Vivus goes to court to stop Hetero infringement of Stendra patents in USA

USA-based Vivus (Nasdaq: VVUS) says it has filed a lawsuit in the US District Court for the District of New Jersey against Hetero USA Inc and Hetero Labs, units of Indian generics drugmaker Hetero, in connection with patent infringement relating to its erectile dysfunction (ED) treatment Stendra (avanafil).

The lawsuit was filed in response to an Abbreviated New Drug Application (ANDA) filed by Hetero. In its application, Hetero seeks to market and sell generic versions of the currently approved doses of Stendra tablets prior to the expiration of US Patents 6,656,935 and 7,501,409, which are listed in the US Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. VIVUS filed the lawsuit on the basis that Hetero's proposed generic products infringe each of these patents.

In accordance with the Hatch-Waxman Act, as a result of having filed a lawsuit within 45 days of the Paragraph IV certification notice, FDA approval of the ANDA will be stayed until the earlier of (i) up to 30 months from the expiration of Stendra's New Chemical Entity exclusivity period (ie, October 27, 2019) or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed.