{"id":28,"date":"2014-07-18T12:22:33","date_gmt":"2014-07-18T12:22:33","guid":{"rendered":"http:\/\/delveinsightblog.wordpress.com\/?p=28"},"modified":"2025-05-02T16:18:23","modified_gmt":"2025-05-02T10:48:23","slug":"celecoxib-first-generic-approval-to-teva-and-mylan-from-fda","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/celecoxib-first-generic-approval-to-teva-and-mylan-from-fda","title":{"rendered":"Celecoxib first Generic Approval to Teva and Mylan from FDA"},"content":{"rendered":"<p>On May 30, 2014, the U.S. Food and Drug Administration approved the first generic versions of Celebrex (celecoxib) capsules. Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.<\/p>\n<p style=\"text-align: justify;\">Celebrex is a Pfizer\u2019s blockbuster anti-inflammatory drug. Global sales of Celebrex exceeded USD2.1 billion, in the first nine months of 2013 which was a 13 percent increase on the same period the previous year.<\/p>\n<p style=\"text-align: justify;\">Patent protection from US16059493A originally expiring in November 2013 in the US, paediatric extensions have extended the expiry of the molecule and composition patents, US 5,466,823 (\u2018823) and US 5,563,165 (\u2018165), a further six months, until May 2014. This was the primary hurdle for the companies wishing to develop generic equivalents.<\/p>\n<p style=\"text-align: justify;\">Celecoxib is a selective COX-2 sulphonamide non-steroidal anti-inflammatory drug (NSAID), marketed by Pfizer, Pharmacia and G.D. Searle (both subsidiaries of Pfizer) under brand name Celebrex, <strong>Celebra<\/strong> for arthritis and <strong>Onsenal <\/strong>for polyps. It is indicated for use in the treatment of osteoarthritis, rheumatoid arthritis in patients 2 years or older, ankylosing spondylitis, acute pain and primary dysmenorrheal.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On May 30, 2014, the U.S. Food and Drug Administration approved the first generic versions of Celebrex (celecoxib) capsules. Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","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":[152,153,154,317,412,413,562,564],"industry":[17225],"therapeutic_areas":[17227],"class_list":["post-28","post","type-post","status-publish","format-standard","hentry","category-articles","tag-celebrex","tag-celecoxib","tag-celecoxib-capsules","tag-inc","tag-mylan","tag-mylan-pharmaceuticals","tag-teva","tag-teva-pharmaceutical-industries","industry-pharmaceutical","therapeutic_areas-immunological-and-autoimmune-disorders"],"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>Teva and Mylan&#039;s generic Celecoxib receives FDA nod<\/title>\n<meta name=\"description\" content=\"Celebrex is a Pfizer\u2019s blockbuster anti-inflammatory drug. Global sales of Celebrex exceeded USD2.1 billion, in the first nine months of 2013.\" \/>\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\/celecoxib-first-generic-approval-to-teva-and-mylan-from-fda\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Teva and Mylan&#039;s generic Celecoxib receives FDA nod\" \/>\n<meta property=\"og:description\" content=\"Celebrex is a Pfizer\u2019s blockbuster anti-inflammatory drug. Global sales of Celebrex exceeded USD2.1 billion, in the first nine months of 2013.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/celecoxib-first-generic-approval-to-teva-and-mylan-from-fda\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2014-07-18T12:22:33+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-05-02T10:48:23+00:00\" \/>\n<meta name=\"author\" content=\"DelveInsight\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"DelveInsight\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Teva and Mylan's generic Celecoxib receives FDA nod","description":"Celebrex is a Pfizer\u2019s blockbuster anti-inflammatory drug. 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