Lupin no longer trying to market generics of Truvada and Viread

Indian drugmaker Lupin (LOPN: BO) seems to have abandoned plans to bring to market generic versions of Gilead Sciences’ (Nasdaq: GILD) blockbuster AIDS drugs Truvada (emtricitabine and tenofovir disoproxil fumarate) and Viread (tenofovir disoproxil fumarate) before patent expiries.

According to a Gilead filing with the US Securities and Exchange Commission last week, in May 2014, Lupin amended its Abbreviated New Drug Applications to certify that it is no longer seeking approval to market generic versions of Truvada and Viread prior to the expiration of the four patents associated with tenofovir disoproxil fumarate in January 2018 (including pediatric exclusivity). As a result, on May 30, the New York District Court granted Gilead and Lupin's Joint Motion for Order of Dismissal in Gilead's patent infringement law suit against Lupin for the tenofovir disoproxil fumarate patents. The Joint Motion for Dismissal will be filed with the Federal Trade Commission and the Department of Justice as required by law.

In 2012, Gilead received notices that Lupin had submitted ANDAs to the US Food and Drug Administration requesting permission to manufacture and market generic versions of Truvada and Viread. In the notices, Lupin alleged that patents associated with tenofovir disoproxil fumarate and emtricitabine are invalid, unenforceable and/or would not be infringed by Lupin's manufacture, use or sale of generic versions of Truvada and Viread. In 2012, Gilead filed law suits against Lupin in US District Court for the Southern District of New York (the NY District Court) for infringement of its patents.