{"id":1691,"date":"2011-06-13T10:03:48","date_gmt":"2011-06-13T14:03:48","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=1691"},"modified":"2011-06-13T10:03:48","modified_gmt":"2011-06-13T14:03:48","slug":"more-on-generic-antiretrovirals","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/more-on-generic-antiretrovirals\/2011\/06\/13\/","title":{"rendered":"More on Generic Antiretrovirals &#8230;"},"content":{"rendered":"<p>In the <a href=\"http:\/\/blogs.nejm.org\/index.php\/surprise-its-generic-combivir\/2011\/05\/26\/\" target=\"_blank\">recent post<\/a> on the approval of generic Combivir &#8212; and the <em>lack <\/em>of availability of generic Epivir (lamivudine, 3TC), which was both anticipated and likely to be more useful &#8212; I speculated there were several possible causes of this surprising turn of events.<\/p>\n<p>But ultimately I concluded, &#8220;In sum, the\u00a0<em>real <\/em>reason there\u2019s no generic 3TC remains a mystery.&#8221;<\/p>\n<p>Last week, however, I received a fascinating email from an industry representative, who has asked that I summarize the turn of events from their perspective:<\/p>\n<ul>\n<li>The Epivir patent in the US expired in May 2010.<\/li>\n<li>A generic company was granted exclusive rights to market a generic in the US for 6 months. \u00a0(This is part of patent law.)<\/li>\n<li>The particular company that was granted exclusivity was not been able to manufacture a product that has met approvability standards by the FDA.<\/li>\n<li>During the period of exclusivity, furthermore, <em>no other company can market a generic either<\/em> &#8212; again, patent law in action.<\/li>\n<\/ul>\n<p>Mystery solved &#8212; and thank you for the clarification.<\/p>\n<p>But I hasten to add that this information was not widely known by HIV\/ID specialists, and furthermore not easy to find. \u00a0One of my colleagues has likened reading rulings on patent law for generics akin to learning English as a second language, a very apt analogy.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the recent post on the approval of generic Combivir &#8212; and the lack of availability of generic Epivir (lamivudine, 3TC), which was both anticipated and likely to be more useful &#8212; I speculated there were several possible causes of this surprising turn of events. But ultimately I concluded, &#8220;In sum, the\u00a0real reason there\u2019s no [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,5,8,9],"tags":[15,216,333,382,384,423,552],"class_list":["post-1691","post","type-post","status-publish","format-standard","hentry","category-hiv","category-infectious-diseases","category-patient-care","category-policy","tag-3tc","tag-combivir","tag-epivir","tag-generic-antiretrovirals","tag-generics","tag-hiv","tag-lamivudine"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/1691","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/comments?post=1691"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/1691\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=1691"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=1691"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=1691"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}