Teva files ANDA for generic version of HIV drug
FOSTER CITY, Calif. Teva is hoping to release its version of an HIV drug before the drug’s patents expire.
Gilead Sciences announced that it had received notice that Teva had applied for regulatory approval with the Food and Drug Administration for a generic version of Viread (tenofovir disoproxil fumarate). The application contained a Paragraph IV certification, which asserts that three of the four patents covering Viread are invalid, unenforceable or won’t be infringed by Teva’s version of the drug.
Under the Hatch-Waxman Act of 1984, Gilead has 45 days from the receipt of the letter to file a patent-infringement lawsuit against Teva. A lawsuit would restrict the FDA from approving Teva’s version of Viread for up to two-and-a-half years or until a court decision. Teva would need to invalidate all four of Viread’s patents before it could launch.
Gilead has a lawsuit pending against Teva in response to Teva’s attempt to gain approval for generic versions of the HIV drugs Truvada (emtricitabine and tenofovir disoproxil fumarate) and Atripla (efavirenz, emtricitabine and tenofovir).