{"id":32457,"date":"2025-06-13T17:36:00","date_gmt":"2025-06-13T12:06:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=32457"},"modified":"2025-09-26T13:05:50","modified_gmt":"2025-09-26T07:35:50","slug":"navigating-the-loss-of-exclusivity","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity","title":{"rendered":"Navigating the Loss of Exclusivity: Big Pharma\u2019s New Playbook"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-69f0e2c34792a\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-69f0e2c34792a\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity\/#The_Patent_Cliff_Returns_Can_Big_Pharma_Innovate_Fast_Enough_to_Stay_on_Top\" >The Patent Cliff Returns: Can Big Pharma Innovate Fast Enough to Stay on Top?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity\/#Merck_A_Case_Study_in_Pipeline-driven_Resilience\" >Merck: A Case Study in Pipeline-driven Resilience<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity\/#AstraZeneca_Diversifying_With_Science-Backed_Expansion\" >AstraZeneca: Diversifying With Science-Backed Expansion<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity\/#Patent_Expirations_Force_a_Reset_Can_BMS_Sustain_Growth_Through_Cost_Discipline\" >Patent Expirations Force a Reset: Can BMS Sustain Growth Through Cost Discipline?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity\/#Outlook_Reinvention_Not_Just_Defense\" >Outlook: Reinvention, Not Just Defense<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-the-patent-cliff-returns-can-big-pharma-innovate-fast-enough-to-stay-on-top\"><span class=\"ez-toc-section\" id=\"The_Patent_Cliff_Returns_Can_Big_Pharma_Innovate_Fast_Enough_to_Stay_on_Top\"><\/span><strong>The Patent Cliff Returns: Can Big Pharma Innovate Fast Enough to Stay on Top?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>For decades, blockbuster drugs have fueled the pharmaceutical industry\u2019s golden age. But as the 2020s unfold, a familiar threat is resurfacing with unprecedented intensity: the Loss of Exclusivity (LOE). With patents on multibillion-dollar therapies nearing expiry, pharma giants are once again bracing for revenue shocks. Yet this time, the stakes are higher\u2014and the playbooks are different. From bold R and D bets to surgical cost-cutting and smarter lifecycle management, the next 5 years will separate the truly future-ready players from the rest. Here is how three of the biggest names, <strong>Merck, AstraZeneca, and BMS<\/strong>, are rewriting their post-LOE strategies.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-merck-a-case-study-in-pipeline-driven-resilience\"><span class=\"ez-toc-section\" id=\"Merck_A_Case_Study_in_Pipeline-driven_Resilience\"><\/span><strong>Merck: A Case Study in Pipeline-driven Resilience<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As Merck nears the Loss of Exclusivity for its flagship immunotherapy, <strong>KEYTRUDA<\/strong>, the company is entering a pivotal phase where strategic foresight is critical. With KEYTRUDA\u2019s patent protection set to expire in <strong>2028<\/strong>, Merck faces substantial revenue pressure, given the drug\u2019s dominant position in its oncology portfolio. In response to this impending challenge, Merck is taking proactive steps to reshape its pipeline and diversify its revenue streams through internal R&amp;D investment, business development efforts, and strategic partnerships, all designed to sustain long-term growth beyond the patent cliff.&nbsp;&nbsp;<\/p>\n\n\n\n<p>In anticipation of the loss of exclusivity, Merck is accelerating its pipeline development, focusing on 20 promising growth drivers across key therapeutic areas such as cardiometabolic diseases, infectious diseases, ophthalmology, and immunology. This diversified approach reflects Merck\u2019s commitment to mitigating the financial impact of patent expirations and ensuring sustained revenue generation.&nbsp;<\/p>\n\n\n\n<p>Among its new assets, Merck is particularly optimistic about <strong>WINREVAIR<\/strong>, a <a href=\"https:\/\/www.delveinsight.com\/blog\/winrevair-for-pulmonary-arterial-hypertension-treatment\">promising therapy for pulmonary arterial hypertension (PAH)<\/a>. WINREVAIR is eligible for 12 years of data exclusivity in the US and 10 years in the EU, with exclusivity potentially extending until <strong>2037<\/strong> through granted patents covering its treatment of PAH. This positions WINREVAIR as a key pillar in Merck\u2019s growth strategy, reinforcing the company\u2019s outlook for long-term success despite the looming loss of KEYTRUDA\u2019s exclusivity.<\/p>\n\n\n\n<p>\u201c<em>We are positioned for long-term leadership in oncology as we continue to diversify and deepen our pipeline. We are excited about cardiometabolic as a future area of growth, including with our oral PCSK9 inhibitor program, where we have important Phase III readouts this year. In immunology, HIV, and ophthalmology, we have opportunities to bring forward first-in-class and\/or best-in-class blockbuster medicines<\/em>,\u201d said Robert Davis, Chairman of the Board, President, and Chief Executive Officer of Merck, during the company\u2019s earnings call in February 2025.<\/p>\n\n\n\n<p>Beyond KEYTRUDA, several other critical assets in Merck\u2019s portfolio are poised to lose exclusivity by 2030, heightening the urgency of its diversification strategy. This wave of impending expirations further emphasizes the need for Merck to rapidly accelerate its pipeline development and strategically expand into high-potential therapeutic areas. By doing so, the company aims to safeguard its long-term growth and mitigate the revenue impact of these upcoming losses, positioning itself for continued success in an increasingly competitive pharmaceutical landscape.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td colspan=\"5\"><strong>Key Merck Assets Facing Loss of Exclusivity by 2030 and Their 2024 Performance<\/strong><\/td><\/tr><tr><td><strong>Drug Name<\/strong><\/td><td><strong>US<\/strong><\/td><td><strong>EU<\/strong><\/td><td><strong>JP<\/strong><\/td><td><strong>2024 Revenue<\/strong><strong>(in USD millions)<\/strong><\/td><\/tr><tr><td><strong>JANUVI<\/strong><\/td><td>2026<sup>a<\/sup><\/td><td>Expired<\/td><td>2025\u20132026<\/td><td>1,334<\/td><\/tr><tr><td><strong>JANUMET\/<\/strong><strong>JANUMET XR<\/strong><\/td><td>2026<sup>a<\/sup><\/td><td>Expired<\/td><td>N\/A<\/td><td>935<\/td><\/tr><tr><td><strong>LENVIMA<\/strong><strong><sup>b<\/sup><\/strong><\/td><td>2026<\/td><td>2026<sup>c<\/sup><\/td><td>2026<\/td><td>1,010<\/td><\/tr><tr><td><strong>BRIDION<\/strong><\/td><td>2026<\/td><td>Expired<\/td><td>Expired<\/td><td>1,764<\/td><\/tr><tr><td><strong>GARDASIL<\/strong><\/td><td>2028<\/td><td>Expired<\/td><td>Expired<\/td><td rowspan=\"2\">8,583<\/td><\/tr><tr><td><strong>GARDASIL 9<\/strong><\/td><td>2028<\/td><td>2030<sup>c<\/sup><\/td><td>2030<\/td><\/tr><tr><td><strong>KEYTRUDA<\/strong><\/td><td>2028<sup>d<\/sup><\/td><td>2031<\/td><td>2032\u20132033<\/td><td>29,482<\/td><\/tr><tr><td><strong>LYNPARZA<\/strong><strong><sup>e<\/sup><\/strong><\/td><td>2027<sup>c<\/sup> (with pending PTE)<\/td><td>2029<sup>c<\/sup><\/td><td>2028\u20132029<\/td><td>1,311<\/td><\/tr><tr><td colspan=\"5\">a. As a result of settlement agreements related to a patent directed to the specific sitagliptin salt form of the products, exclusivity will extend through May 2026 for Januvia and JANUMET and through July 2026 for JANUMET XR.<br>b. Part of a global strategic oncology collaboration with Eisai.<br>c. Eligible for six months of pediatric market exclusivity.<br>d. The compound patent family contains two additional patents that expire in 2029 due to patent term adjustment resulting from patent office delay. These patents are based on the initial discovery of the active ingredient in KEYTRUDA. While these patents may provide additional protection, the Company expects that they will be the subject of litigation in the future.<br>e. Part of a global strategic oncology collaboration with AstraZeneca.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>With the expiration of several major assets, Merck is set to lose nearly <strong>USD 45 billion<\/strong> in revenue-generating products by <strong>2030<\/strong>. KEYTRUDA, the company\u2019s highest-earning therapy, contributed approximately <strong>USD 29 billion<\/strong> to Merck\u2019s revenue in 2024.<\/p>\n\n\n\n<p>To extend KEYTRUDA\u2019s patent life, Merck is leveraging additional compound patents that expire in <strong>2029<\/strong> due to patent term adjustments related to regulatory delays. Although these patents, stemming from the original discovery of KEYTRUDA\u2019s active ingredient, may provide some protection, they are expected to face significant litigation.<\/p>\n\n\n\n<p>In parallel, Merck is expanding KEYTRUDA\u2019s clinical applications, exploring its potential in hepatocellular, ovarian, and small-cell lung cancers, as well as evaluating a subcutaneous formulation combined with berahyaluronidase alfa for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-non-small-cell-lung-cancer-market\">first-line treatment of metastatic non-small cell lung cancer<\/a>.&nbsp;<\/p>\n\n\n\n<p>As Merck prepares for the post-KEYTRUDA era, the company is shifting focus to WINREVAIR, which generated <strong>USD 419 million<\/strong> in sales in <strong>2024<\/strong>. WINREVAIR is poised to play a pivotal role in Merck\u2019s post-KEYTRUDA growth strategy, providing a promising avenue for future revenue.<\/p>\n\n\n\n<p>\u201c<em>I would just say, overall, our confidence in WINREVAIR and the potential benefit for patients with PAH and, in turn, its importance for growth are unchanged<\/em>,\u201d said Robert Davis, Chairman of the Board, President, and Chief Executive Officer of Merck, during the company\u2019s earnings call in February 2025.<\/p>\n\n\n\n<p>According to Merck\u2019s Q4 2024 earnings presentation, the company generated approximately <strong>USD 57 billion<\/strong> in <strong>2024<\/strong>, but this figure is expected to undergo a significant shift in the coming years. Merck aims to generate <strong>USD 50 billion<\/strong> in revenue by the <strong>mid-2030s<\/strong> through a diversified portfolio across various therapeutic areas.&nbsp;<\/p>\n\n\n\n<p>While oncology will continue to be the leading therapy area, the company is currently over-dependent on this segment, a reliance that is poised to change. By the mid-2030s, revenue from other therapy areas, including cardiometabolic, immunology, ophthalmology, and infectious diseases, is expected to contribute approximately <strong>50%<\/strong> of Merck\u2019s total revenue, reflecting the company\u2019s strategic pivot toward a more balanced and diversified growth model.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"321\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140014\/Merck-Revenue-in-USD-Billion-1024x321.png\" alt=\"Merck-Revenue-(in-USD-Billion)\" class=\"wp-image-32462\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140014\/Merck-Revenue-in-USD-Billion-1024x321.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140014\/Merck-Revenue-in-USD-Billion-300x94.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140014\/Merck-Revenue-in-USD-Billion-150x47.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140014\/Merck-Revenue-in-USD-Billion-768x241.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140014\/Merck-Revenue-in-USD-Billion-1536x481.png 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140014\/Merck-Revenue-in-USD-Billion-2048x642.png 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>Merck\u2019s strategic shift toward innovation and portfolio diversification highlights its proactive approach to navigating upcoming patent expirations. As the company moves into the post-KEYTRUDA landscape, the performance of its new and advancing assets, including WINREVAIR, will be central to driving sustained long-term growth.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"AstraZeneca_Diversifying_With_Science-Backed_Expansion\"><\/span><strong>AstraZeneca: Diversifying With Science-Backed Expansion<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>AstraZeneca is entering a pivotal phase marked by the approaching loss of exclusivity for several key therapies. With a strong emphasis on scientific innovation, the company is strategically positioning itself to mitigate the impact of upcoming patent expirations through a combination of internal pipeline advancement, targeted acquisitions, and global expansion efforts.&nbsp;<\/p>\n\n\n\n<p>Several high-value assets from AstraZeneca are approaching the end of their patent protection by <strong>2030<\/strong>, signaling potential revenue challenges ahead. Among them, <strong>FARXIGA<\/strong> stands out as the company\u2019s top-performing cardiovascular drug, having generated approximately <strong>USD 7.7 billion<\/strong> in revenue in <strong>2024<\/strong>. With its patent set to expire in <strong>2026<\/strong>, AstraZeneca faces mounting pressure to offset the anticipated loss through pipeline innovation or strategic lifecycle management.<\/p>\n\n\n\n<p>In addition to FARXIGA, several other AstraZeneca assets across key therapeutic areas, including oncology, rare diseases, respiratory, and immunology, are poised to lose market exclusivity by 2030. This upcoming wave of expirations underscores the need for AstraZeneca to bolster its late-stage pipeline and explore new growth drivers to sustain momentum in the face of looming patent cliffs.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td colspan=\"5\"><strong>Key AstraZeneca Assets Facing Loss of Exclusivity by 2030 and Their 2024 Performance<\/strong><\/td><\/tr><tr><td><strong>Drug Name<\/strong><\/td><td><strong>US<\/strong><\/td><td><strong>EU<\/strong><\/td><td><strong>JP<\/strong><\/td><td><strong>2024 Revenue<\/strong><strong>(in USD millions)<\/strong><\/td><\/tr><tr><td><strong>LYNPARZA (olaparib)<\/strong><\/td><td>2024, 2027(2024\u20132041)<\/td><td>2029(2024\u20132029)<\/td><td>2029(2024\u20132034)<\/td><td>3,072<\/td><\/tr><tr><td><strong>FARXIGA\/FORXIGA (dapagliflozin)<\/strong><\/td><td>2026&nbsp;(2025\u20132040)<\/td><td>2028&nbsp;(2027, 2028<sup>2)<\/sup><\/td><td>2024\u20132025(2028\u20132040)<\/td><td>7,656<\/td><\/tr><tr><td><strong>FASENRA (benralizumab)<\/strong><\/td><td>2024&nbsp;(2028\u20132034)&nbsp;<\/td><td>2025(2028\u20132034)<\/td><td>2025(2034)<\/td><td>1,689<\/td><\/tr><tr><td><strong>SYMBICORT<\/strong><strong>(budesonide\/<\/strong><strong>formoterol)<\/strong><\/td><td>2025\u20132029<\/td><td>Expired<\/td><td>Expired<\/td><td>2,879<\/td><\/tr><tr><td><strong>SOLIRIS<\/strong><strong>(eculizumab)<\/strong><\/td><td>2027<sup>a<\/sup>&nbsp;(2025\u20132032)<\/td><td>2027&nbsp;(2029)<\/td><td>2027&nbsp;(2029)<\/td><td>2,588<\/td><\/tr><tr><td><strong>BRILINTA\/BRILIQUE (ticagrelor)<\/strong><\/td><td>2025(2030\u20132036)<\/td><td>2025&nbsp;(2037)<\/td><td>2024&nbsp;(2025\u20132030)<\/td><td>1,333<\/td><\/tr><tr><td colspan=\"5\">a. Settled with Amgen and Samsung Bioepis for a licensed biosimilar entry date of March 2025.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>AstraZeneca is strategically positioned to manage the upcoming patent cliff, supported by a robust pipeline of over <strong>90 late-stage<\/strong> trials with an average non-risk-adjusted peak-year revenue potential of <strong>USD 1 billion<\/strong> per asset. With a revenue target of <strong>USD 80 billion<\/strong> by <strong>2030<\/strong>, the company remains focused on core therapeutic areas, oncology, respiratory, and cardiovascular diseases, while expanding into immunology and rare diseases. Its growing interest in cell therapy reflects a forward-looking strategy to address complex immune disorders through innovation and advanced technologies.<\/p>\n\n\n\n<p><em>\u201cWe are making a very important step toward the achievement of our strategic ambitions, in particular, the USD 80 billion sales in 2030. And we are progressing high-value readouts that will unlock further growth,<\/em>\u201d said Pascal Soriot, Executive Director and Chief Executive Officer of AstraZeneca, during the company\u2019s earnings call in February 2025.<\/p>\n\n\n\n<p><strong>Oncology <\/strong>continues to be the company\u2019s primary growth engine, generating <strong>USD 22.4 billion <\/strong>in 2024\u2014up 24% year-over-year. <a href=\"https:\/\/www.delveinsight.com\/report-store\/tagrisso-drug-insight-and-market-forecast\"><strong>TAGRISSO<\/strong><\/a><strong> <\/strong>led with over <strong>USD 6.5 billion <\/strong>in sales and remains the market leader in frontline EGFR-mutated NSCLC. <a href=\"https:\/\/www.delveinsight.com\/report-store\/lynparza-drug-insight-and-market-forecast\"><strong>LYNPARZA<\/strong><\/a><strong> <\/strong>exceeded <strong>USD 3 billion<\/strong>, while <strong>IMFINZI <\/strong>and <strong>IMJUDO <\/strong>together approached <strong>USD 5 billion <\/strong>in revenues. <strong>CALQUENCE <\/strong>and <strong>ENHERTU <\/strong>each delivered over <strong>USD 2 billion<\/strong>, with CALQUENCE sustaining its lead in frontline chronic lymphocytic leukemia (CLL), supported by anticipated volume growth and the potential approval of AMPLIFY targeting the finite therapy segment.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"398\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140053\/AstraZeneca-Revenue-in-2024-1024x398.png\" alt=\"AstraZeneca-Revenue-in-2024\" class=\"wp-image-32464\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140053\/AstraZeneca-Revenue-in-2024-1024x398.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140053\/AstraZeneca-Revenue-in-2024-300x117.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140053\/AstraZeneca-Revenue-in-2024-150x58.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140053\/AstraZeneca-Revenue-in-2024-768x299.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140053\/AstraZeneca-Revenue-in-2024-1536x597.png 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140053\/AstraZeneca-Revenue-in-2024-2048x796.png 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>Recent regulatory momentum, such as the EU recommendation for IMFINZI in resectable <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-muscle-invasive-bladder-cancer-market\">muscle-invasive bladder cancer (MIBC)<\/a>, and the uptake of <strong>TRUQAP<\/strong> in second-line biomarker-altered breast cancer further highlight AstraZeneca\u2019s ability to drive growth through indication expansion.&nbsp;<\/p>\n\n\n\n<p>Although AstraZeneca\u2019s rare disease segment is under pressure, mainly from declining <strong>SOLIRIS<\/strong> sales due to patient shifts to <strong>ULTOMIRIS<\/strong> and biosimilar competition such as the <strong>April 2024<\/strong> launch of <strong>EPYSQLI<\/strong>, the company is entering a critical juncture with a significant patent cliff ahead. As high-revenue assets like FARXIGA and LYNPARZA approach loss of exclusivity, AstraZeneca\u2019s robust oncology portfolio, deep late-stage pipeline, and strategic investments in innovation and cell therapy position it well to navigate these challenges and sustain long-term growth beyond 2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Patent_Expirations_Force_a_Reset_Can_BMS_Sustain_Growth_Through_Cost_Discipline\"><\/span><strong>Patent Expirations Force a Reset: Can BMS Sustain Growth Through Cost Discipline?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Bristol Myers Squibb is at a critical juncture as it confronts the financial impact of an upcoming loss of exclusivity for key assets. In response, the company has initiated sweeping cost-cutting measures aimed at preserving margins and reallocating resources toward pipeline innovation and strategic growth areas. This shift marks a recalibration of Bristol Myers Squibb\u2019s operating model, offering a glimpse into how the company is rewriting its playbook to remain competitive in a post-patent world.<\/p>\n\n\n\n<p>Several high-revenue assets at Bristol Myers Squibb are nearing loss of exclusivity, placing substantial pressure on the company\u2019s future earnings. In <strong>2024,<\/strong> the company reported revenue of approximately <strong>USD 48.3 billion<\/strong>, with <strong>ELIQUIS (apixaban)<\/strong> alone contributing <strong>USD 13.3 billion<\/strong>. Set to expire in <strong>2026<\/strong>, ELIQUIS represents a major revenue pillar, and its upcoming loss underscores the scale of exposure Bristol Myers Squibb faces as it braces for a wave of patent expirations that could reshape its earnings trajectory. Beyond <strong>ELIQUIS<\/strong>, several high-performing therapies are approaching the end of their market exclusivity, intensifying the pressure on Bristol Myers Squibb\u2019s revenue sustainability.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td colspan=\"5\"><strong>Key BMS Assets Facing Loss of Exclusivity by 2030 and Their 2024 Performance<\/strong><\/td><\/tr><tr><td><strong>Drug Name<\/strong><\/td><td><strong>US<\/strong><\/td><td><strong>EU<\/strong><\/td><td><strong>JP<\/strong><\/td><td><strong>2024 Revenue<\/strong><strong>(in USD millions)<\/strong><\/td><\/tr><tr><td><strong>YERVOY (ipilimumab)<\/strong><\/td><td>2025<\/td><td>2026<\/td><td>2025<\/td><td>2,530<\/td><\/tr><tr><td><strong>ORENCIA (abatacept)<\/strong><\/td><td>2026<\/td><td>2026<\/td><td>2026<\/td><td>3,682<\/td><\/tr><tr><td><strong>POMALYST\/IMNOVID (pomalidomide)&nbsp;<\/strong><\/td><td>2026<\/td><td>Generics available<\/td><td>2026<\/td><td>3,545<\/td><\/tr><tr><td><strong>REVLIMID (lenalidomide)<\/strong><\/td><td>2026<\/td><td>Generics available<\/td><td>Generics available<\/td><td>5,773&nbsp;<\/td><\/tr><tr><td><strong>OPDIVO (nivolumab)<\/strong><\/td><td>2028<\/td><td>2030<\/td><td>2031<\/td><td>9,304&nbsp;<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>To navigate the wave of upcoming patent expirations, Bristol Myers Squibb is relying on both operational restructuring and lifecycle management strategies. The recent launch of a subcutaneous formulation of <strong>OPDIVO (nivolumab)<\/strong> reflects an effort to sustain its immuno-oncology franchise beyond the drug&#8217;s expected loss of exclusivity in <strong>2028<\/strong>. While early physician outreach is underway, the projected <strong>30\u201340%<\/strong> conversion from IV to subcutaneous remains an internal estimate, and actual uptake will depend on market dynamics and clinical adoption.<\/p>\n\n\n\n<p>In a bold move to strengthen its oncology pipeline, Bristol Myers Squibb has teamed up with BioNTech in a high-stakes, <strong>~USD 11 billion<\/strong> partnership to co-develop and co-commercialize the investigational bispecific antibody BNT327 for solid tumors. The deal includes a <strong>USD 1.5 billion<\/strong> upfront payment and <strong>USD 2 billion<\/strong> in guaranteed milestone payments through <strong>2028<\/strong>, all recorded as acquired in-process research and development (IPR&amp;D) expenses. BioNTech stands to gain an additional <strong>USD 7.6 billion<\/strong> in potential development, regulatory, and commercial milestones. With a 50:50 split on development costs, manufacturing responsibilities, and global profits and losses, this collaboration signals Bristol Myers Squibb\u2019s aggressive push to fuel future growth through innovation and strategic alliances.<\/p>\n\n\n\n<p><em>\u201cWith respect to the cost programs, just a bit of context. As we were executing on last year\u2019s program, we cataloged a number of opportunities for us to become a more agile company, to become more nimble and speedy in terms of how we operate,\u201d <\/em>said Christopher S. Boerner, Chairman and Chief Executive Officer of Bristol Myers Squibb during the Q4 2024 Earnings Call.<\/p>\n\n\n\n<p>On the cost front, Bristol Myers Squibb has expanded its cost-saving program by an additional <strong>USD 2 billion<\/strong>, aiming to reduce operating expenses from <strong>USD 16 billion<\/strong> to <strong>USD 15 billion<\/strong> by <strong>2027<\/strong>. Of this, <strong>USD 1 billion<\/strong> is expected to be realized in <strong>2025<\/strong>, with the remaining <strong>USD 1 billion<\/strong> by the end of <strong>2027<\/strong>. Unlike the initial <strong>USD 1.5 billion<\/strong> initiative, where most savings were reinvested, this expanded effort is intended to drop entirely to the bottom line. The savings are split evenly between organizational redesign and enhancements in operational efficiency. While this aggressive approach may support short-term financial stability, it also raises concerns about overdependence on internal restructuring at a time when sustained investment in innovation remains critical.<\/p>\n\n\n\n<p>The <a href=\"https:\/\/www.delveinsight.com\/blog\/5-schizophrenia-drugs-challenging-bms-karxt\">approval of <strong>COBENFY<\/strong><\/a> in <strong>September 2024<\/strong> highlights continued investment in select pipeline assets, but the company\u2019s decision not to issue long-term guidance may reflect caution amid a shifting revenue base. While Bristol Myers Squibb aims to exit the decade with top-tier growth, execution risks remain as it balances cost containment with the need to replenish its portfolio.<\/p>\n\n\n\n<p><em>\u201cWe&#8217;re not going to be giving long-term guidance as a standard course. This reflects the philosophy that we have that we&#8217;re going to guide to what we and you can hold us accountable for. But what we&#8217;ve also been very clear on is that our focus continues to be on driving top-tier growth exiting this decade,\u201d<\/em> said Christopher S. Boerner, Chairman and Chief Executive Officer of Bristol Myers Squibb during the Q4 2024 Earnings Call.<\/p>\n\n\n\n<p>As Bristol Myers Squibb navigates a pivotal period marked by major loss of exclusivity events, its strategy reflects both urgency and uncertainty. While expanded cost-cutting measures and lifecycle extensions, such as the subcutaneous OPDIVO, may provide temporary relief, they also underscore a heavier reliance on defensive tactics rather than bold innovation. However, recent moves like the high-stakes alliance with BioNTech signal a growing emphasis on external innovation to strengthen its oncology pipeline and offset future revenue gaps. The absence of long-term financial guidance raises questions about visibility into future growth, especially as pressure mounts to replace high-revenue assets with new launches. Ultimately, the success of BMS\u2019s post-patent playbook will depend not just on operational discipline but on its ability to deliver meaningful pipeline-driven value in an increasingly competitive environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Outlook_Reinvention_Not_Just_Defense\"><\/span><strong>Outlook: Reinvention, Not Just Defense<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As Merck, AstraZeneca, and Bristol Myers Squibb approach the patent cliff, each company is taking a distinct strategic path to sustain growth. Merck is proactively diversifying beyond oncology, with a focus on cardiometabolic and immunology assets like WINREVAIR, aiming for an equal split between oncology and other therapy areas by the mid-2030s. AstraZeneca, while facing the LOE of FARXIGA and other assets, is better insulated by a deep pipeline and a strong innovation engine spanning oncology, CVRM, and <a href=\"https:\/\/www.delveinsight.com\/rare-diseases\">rare diseases<\/a>. In contrast, Bristol Myers Squibb is leaning heavily into operational streamlining to preserve margins amid LOE for ELIQUIS and others, while also advancing external innovation through high-value partnerships such as its recent alliance with BioNTech. Collectively, these strategies underscore the evolving playbooks big pharma is adopting to navigate the loss of exclusivity and reposition for sustainable growth.<\/p>\n\n\n\n<p><strong>Frequently Asked Questions<\/strong><\/p>\n\n\n\n<div class=\"schema-faq wp-block-yoast-faq-block\"><div class=\"schema-faq-section\" id=\"faq-question-1758872042818\"><strong class=\"schema-faq-question\"><strong>What does \u201closs of exclusivity\u201d (LOE) mean for pharmaceutical companies?<\/strong><\/strong> <p class=\"schema-faq-answer\">Loss of exclusivity refers to the expiration of patent protection or market exclusivity for a drug, which allows generic or biosimilar competitors to enter. This often leads to significant revenue erosion for the innovator company.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1758872047254\"><strong class=\"schema-faq-question\"><strong>How are top pharma companies preparing for upcoming LOEs on blockbuster drugs?<\/strong><\/strong> <p class=\"schema-faq-answer\">Companies are responding by diversifying their pipelines, accelerating R&amp;D, forging partnerships, cutting costs, and pursuing life-cycle management strategies (e.g., new formulations or indications).<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1758872047728\"><strong class=\"schema-faq-question\"><strong>What is a case example of a company facing LOE and how are they managing it?<\/strong><\/strong> <p class=\"schema-faq-answer\">Merck is preparing for the impending LOE of its blockbuster <strong>Keytruda<\/strong> (expected around 2028) by investing in new assets across immunology, cardiometabolic diseases, and ophthalmology, and by expanding indications of existing drugs.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1758872048176\"><strong class=\"schema-faq-question\"><strong>Why is lifecycle management important post-LOE?<\/strong><\/strong> <p class=\"schema-faq-answer\">Lifecycle management helps extend market value by reformulating drugs (e.g. subcutaneous vs intravenous), expanding indications, or combining drugs, thereby delaying revenue decline after exclusivity ends.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1758872049417\"><strong class=\"schema-faq-question\"><strong>What long-term strategies should pharma adopt to survive recurring LOE waves?<\/strong><\/strong> <p class=\"schema-faq-answer\">Pharma firms should shift from defensive tactics to reinvention\u2014building resilient, diversified pipelines, strengthening innovation, and ensuring they are less reliant on single blockbuster drugs.<\/p> <\/div> <\/div>\n","protected":false},"excerpt":{"rendered":"<p>The Patent Cliff Returns: Can Big Pharma Innovate Fast Enough to Stay on Top? For decades, blockbuster drugs have fueled the pharmaceutical industry\u2019s golden age. But as the 2020s unfold, a familiar threat is resurfacing with unprecedented intensity: the Loss of Exclusivity (LOE). With patents on multibillion-dollar therapies nearing expiry, pharma giants are once again [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":32466,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[96,22415,18438,22299,17529,16851,20755,17967,345,22572,395,431,22573,22149],"industry":[17225],"therapeutic_areas":[17242,17228],"class_list":["post-32457","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-astrazeneca","tag-bristol-mayer-squibb","tag-calquence","tag-cobenfy","tag-eliquis","tag-enhertu","tag-farxiga","tag-imfinzi","tag-keytruda","tag-loss-of-exclusivity","tag-merck","tag-opdivo","tag-patent-cliff","tag-winrevair","industry-pharmaceutical","therapeutic_areas-cardiovascular-diseases","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The End of Exclusivity: Opportunity or Crisis for Big Players?<\/title>\n<meta name=\"description\" content=\"As Merck, AstraZeneca, and BMS approach the patent cliff, each company is taking a distinct strategic path to sustain growth.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The End of Exclusivity: Opportunity or Crisis for Big Players?\" \/>\n<meta property=\"og:description\" content=\"As Merck, AstraZeneca, and BMS approach the patent cliff, each company is taking a distinct strategic path to sustain growth.\" 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Joshi"},"sameAs":["http:\/\/Delveinsight.com"]},{"@type":"Question","@id":"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity#faq-question-1758872042818","position":1,"url":"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity#faq-question-1758872042818","name":"What does \u201closs of exclusivity\u201d (LOE) mean for pharmaceutical companies?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Loss of exclusivity refers to the expiration of patent protection or market exclusivity for a drug, which allows generic or biosimilar competitors to enter. This often leads to significant revenue erosion for the innovator company.","inLanguage":"en-US"},"inLanguage":"en-US"},{"@type":"Question","@id":"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity#faq-question-1758872047254","position":2,"url":"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity#faq-question-1758872047254","name":"How are top pharma companies preparing for upcoming LOEs on blockbuster drugs?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Companies are responding by diversifying their pipelines, accelerating R&amp;D, forging partnerships, cutting costs, and pursuing life-cycle management strategies (e.g., new formulations or indications).","inLanguage":"en-US"},"inLanguage":"en-US"},{"@type":"Question","@id":"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity#faq-question-1758872047728","position":3,"url":"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity#faq-question-1758872047728","name":"What is a case example of a company facing LOE and how are they managing it?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Merck is preparing for the impending LOE of its blockbuster <strong>Keytruda<\/strong> (expected around 2028) by investing in new assets across immunology, cardiometabolic diseases, and ophthalmology, and by expanding indications of existing drugs.","inLanguage":"en-US"},"inLanguage":"en-US"},{"@type":"Question","@id":"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity#faq-question-1758872048176","position":4,"url":"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity#faq-question-1758872048176","name":"Why is lifecycle management important post-LOE?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Lifecycle management helps extend market value by reformulating drugs (e.g. subcutaneous vs intravenous), expanding indications, or combining drugs, thereby delaying revenue decline after exclusivity ends.","inLanguage":"en-US"},"inLanguage":"en-US"},{"@type":"Question","@id":"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity#faq-question-1758872049417","position":5,"url":"https:\/\/www.delveinsight.com\/blog\/navigating-the-loss-of-exclusivity#faq-question-1758872049417","name":"What long-term strategies should pharma adopt to survive recurring LOE waves?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Pharma firms should shift from defensive tactics to reinvention\u2014building resilient, diversified pipelines, strengthening innovation, and ensuring they are less reliant on single blockbuster drugs.","inLanguage":"en-US"},"inLanguage":"en-US"}]}},"author_meta":{"display_name":"Sandeep Joshi","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/sjoshidelveinsight-com"},"featured_img":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/13140238\/navigating-the-loss-of-exclusivity-300x183.png","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Articles<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Articles<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">AstraZeneca<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Bristol Mayer Squibb<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Calquence<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">COBENFY<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Eliquis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Enhertu<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Farxiga<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Imfinzi<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Keytruda<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Loss of Exclusivity<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Merck<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Opdivo<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Patent Cliff<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">WINREVAIR<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">AstraZeneca<\/span>","<span class=\"advgb-post-tax-term\">Bristol Mayer Squibb<\/span>","<span class=\"advgb-post-tax-term\">Calquence<\/span>","<span class=\"advgb-post-tax-term\">COBENFY<\/span>","<span class=\"advgb-post-tax-term\">Eliquis<\/span>","<span class=\"advgb-post-tax-term\">Enhertu<\/span>","<span class=\"advgb-post-tax-term\">Farxiga<\/span>","<span class=\"advgb-post-tax-term\">Imfinzi<\/span>","<span class=\"advgb-post-tax-term\">Keytruda<\/span>","<span class=\"advgb-post-tax-term\">Loss of Exclusivity<\/span>","<span class=\"advgb-post-tax-term\">Merck<\/span>","<span class=\"advgb-post-tax-term\">Opdivo<\/span>","<span class=\"advgb-post-tax-term\">Patent Cliff<\/span>","<span class=\"advgb-post-tax-term\">WINREVAIR<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 11 months ago","modified":"Updated 7 months ago"},"absolute_dates":{"created":"Posted on Jun 13, 2025","modified":"Updated on Sep 26, 2025"},"absolute_dates_time":{"created":"Posted on Jun 13, 2025 5:36 pm","modified":"Updated on Sep 26, 2025 1:05 pm"},"featured_img_caption":"navigating-the-loss-of-exclusivity","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/32457","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/14"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=32457"}],"version-history":[{"count":8,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/32457\/revisions"}],"predecessor-version":[{"id":33521,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/32457\/revisions\/33521"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/32466"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=32457"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=32457"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=32457"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=32457"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=32457"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}