AstraZeneca initiated patent infringement proceedings in the United States against Aurobindo Pharma, USA, in connection with an Abbreviated New Drug Application (ANDA) filed by Aurobindo with the USFDA. The ANDA sought market approval for the commercial manufacture, use, and sale of Saxagliptin hydrochloride tablets in 2.5 mg and 5 mg strengths before the expiry of AstraZeneca’s US patent, under Section 505(j) of the Federal Food, Drug, and Cosmetic Act.<\/p>\n
AstraZeneca is the sole marketing authorisation holder for Saxagliptin hydrochloride tablets in the United States, sold under the brand name Onglyza. Onglyza (saxagliptin) is an oral dipeptidyl peptidase 4 (DPP-4) inhibitor used for the treatment of Type-2 Diabetes Mellitus. The drug promotes insulin secretion by the pancreas and inhibits excess sugar production by the liver, and is noted for its ability to control blood sugar without the weight gain associated with certain other anti-diabetic treatments.<\/p>\n
Onglyza was originally developed by Bristol-Myers Squibb. AstraZeneca partnered in its development from 2007, and the two companies jointly submitted an NDA to the USFDA in 2008. Marketing approval for the treatment of Type-2 Diabetes was granted in 2009. Saxagliptin also received marketing authorisation from the European Medicines Agency and was approved in more than 66 countries, including India. AstraZeneca subsequently acquired outright ownership of the drug from Bristol-Myers Squibb.<\/p>\n
In February 2014, the FDA placed Saxagliptin under review and issued a safety announcement concerning potential heart failure risks, requiring the manufacturers to submit clinical trial data within one month. The data submitted in support of the original NDA had been presented as excluding any cardiovascular risk.<\/p>\n
In the first week of December of that year, Aurobindo informed AstraZeneca by notice letter that it had submitted an ANDA to the FDA seeking approval to manufacture, use, and sell Saxagliptin hydrochloride tablets before the expiry of the relevant patent. According to a court order, the submission of an ANDA prior to patent expiry constitutes a technical act of infringement under the applicable US framework, and preliminary information indicated that one or more claims of the unexpired patent would be infringed by the product described in Aurobindo’s ANDA. AstraZeneca sought to enjoin Aurobindo from obtaining approval, contending that approval before patent expiry would cause it irreparable harm.<\/p>\n
This article is for general information and does not constitute legal advice. Readers should consult a qualified attorney before acting on any matter discussed here.<\/p>\n","protected":false},"excerpt":{"rendered":"
Astrazeneca has brought a patent infringement case against Aurobindo Pharma over an ANDA filing for Onglyza\u2019s generic version in the US. The dispute centres on the alleged infringement of Saxagliptin hydrochloride patents before their expiry.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"iawp_total_views":29,"footnotes":""},"categories":[6,14],"tags":[6919,495,6918,12815,158,12816,5994,6920],"class_list":["post-17682","post","type-post","status-publish","format-standard","hentry","category-intellectual-property","category-patents","tag-anda-litigation","tag-astrazeneca","tag-aurobindo-pharma","tag-onglyza-patent-infringement-anda","tag-patent-litigation","tag-saxagliptin-hydrochloride","tag-type-2-diabetes","tag-usfda"],"_links":{"self":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/17682","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/comments?post=17682"}],"version-history":[{"count":4,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/17682\/revisions"}],"predecessor-version":[{"id":149713,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/posts\/17682\/revisions\/149713"}],"wp:attachment":[{"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/media?parent=17682"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/categories?post=17682"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bananaip.com\/intellepedia\/wp-json\/wp\/v2\/tags?post=17682"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}