{"id":659,"date":"2013-12-01T08:03:53","date_gmt":"2013-12-01T08:03:53","guid":{"rendered":"https:\/\/sagaciousresearch.com\/blog\/?p=659"},"modified":"2022-09-26T05:55:14","modified_gmt":"2022-09-26T05:55:14","slug":"patent-lawsuit-of-actavis-vs-merck-co-over-generic-version-of-nuvaring","status":"publish","type":"post","link":"https:\/\/sagaciousresearch.com\/blog\/patent-lawsuit-of-actavis-vs-merck-co-over-generic-version-of-nuvaring","title":{"rendered":"Patent Lawsuit of Actavis vs. Merck &#038; Co. Over Generic Version of \u201cNuvaRing\u201d"},"content":{"rendered":"\n<p>A patent lawsuit has been filed against <strong>Warner Chilcott Company LLC<\/strong>, a <strong>subsidiary of Actavis<\/strong> for preventing commercialization of drug manufacturers ANDA product prior to the expiration of U.S. Patent No 5,989,581 related to an estrogen\/progestin combination hormonal contraceptive \u201cNuvaRing\u201d that is assigned to <strong>Merck &amp; Co.<\/strong>\u2019s <strong>NuvaRing<\/strong> is a blockbuster drug with total U.S. sales of ~$560 million in the quarter ending October 2013.<\/p>\n\n\n\n<p>Actavis had filed the ANDA with the U.S. Food and Drug Administration seeking approval to market Ethinyl Estradiol and Etonogestrel Vaginal Ring, 0.015 mg\/24 hour and 0.12 mg\/24 hour. It is a generic version of Merck &amp; Co.&#8217;s NuvaRing, indicated for use by women to prevent pregnancy. This generic drug product, if is <strong>bioequivalent <\/strong>, will be approved by FDA and get listed in FDA\u2019s Orange Book. FDA lists all the approved products, both innovator and generic in its<em> Orange Book<\/em>. Also, it will be comparable to branded product in dosage form, strength, route of administration, quality, performance characteristics and intended use.<\/p>\n\n\n\n<p>&nbsp;Actavis is presumed to be the &#8220;first applicant&#8221; to file an ANDA for the generic version of NuvaRing and, should it be approved, may be entitled to 180 days of generic market exclusivity.&nbsp; The data furnished in an ANDA provides for the review and ultimate approval of a <strong>generic drug product<\/strong>. <strong>Generic drug applications<\/strong> are termed &#8220;abbreviated&#8221; because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.<\/p>\n\n\n\n<p>&nbsp;The aforementioned lawsuit was filed under the provisions of the <strong>Hatch-Waxman Act<\/strong> . Since 2003, this US patent law has ensured increased availability and access to generic drugs by limiting the use of 30-month stays by brand-name drug sponsors and by clarifying the types of patents that must and must not be submitted to FDA.<\/p>\n\n\n\n<p><strong>Our Services:<\/strong><br><a href=\"https:\/\/patentdraftingcatalyst.com\/\">Patent Drafting Support<\/a> | Fixed and Cost-effective Patent Searches | <strong><a href=\"https:\/\/sagaciousresearch.com\/patentability-search\">Patent Searches<\/a><\/strong> | Prior Art Search&nbsp;|&nbsp;<strong><a href=\"https:\/\/sagaciousresearch.com\/biological-sequence-search\">Bio-Sequence Patents<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A patent lawsuit has been filed against Warner Chilcott Company LLC, a subsidiary of Actavis for preventing commercialization of drug manufacturers ANDA product prior to the expiration of U.S. Patent No 5,989,581 related to&#46;&#46;&#46;<\/p>\n","protected":false},"author":1,"featured_media":25857,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[],"tags":[],"coauthors":[983],"class_list":["post-659","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Patent Lawsuit of Actavis vs. Merck &amp; Co. 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