Vivus says Actavis has filed ANDA for generic Qsymia

US drug developer Vivus (Nasdaq: VVUS) disclosed on Friday that the company had received notice from generics major Actavis (NYSE: ACT) that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration for generic versions of all strengths of obesity agent Qsymia (phentermine and topiramate extended-release).

It said that the notice from Actavis included a Paragraph IV certification with respect to all of the company’s patents listed in the FDA’s Orange Book on the date of the company’s receipt of the notice. A paragraph IV certification is a certification by a generic applicant that patents covering the branded product are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of the generic product. Qsymia was launched in the USA in 2012 (The Pharma Letter September 19, 2012).

Vivus added that it is currently reviewing the details of Actavis’ notice. Under the Hatch-Waxman Act, the company has 45 days from receipt of the notice to determine if it will file a patent infringement suit. If the company brings such a suit, a stay of approval of up to 30 months will be imposed by the FDA on Actavis’ ANDA. "The company intends to vigorously enforce its intellectual property rights, but cannot predict the outcome of this matter," Vivus stated.