FDA decides Teva is sole first-to-file on Provigil; Mylan argues ruling

Israel-based Teva Pharmaceutical Industries (Nasdaq: TEVA) said on April 5 that the US Food and Drug Administration has decided that its wholly owned subsidiary, Teva Pharmaceuticals USA, is sole first-to-file for both Orange Book patents listed for Provigil (modafinil), a drug for the treatment of narcolepsy, and therefore Teva’s ANDA alone is entitled to 180-day exclusivity.

Cephalon launched generic Provigil on March 29 (The Pharma Letter April 1) and the FDA has also decided that such launch triggered the exclusivity.

Teva, the world’s largest generic drugmaker, said it expects Par Pharmaceutical (NYSE: PRX) to launch a second generic product on April 6 pursuant to the agreement with the US Federal Trade Commission in connection with the Cephalon acquisition last year. Par confirmed on Friday that it had, indeed, starting shipping its generic version of Provigil, which has annual sales of around $1.1 billion in the USA.