Pfizer’s Lyrica Gets Split Decision As FDA Raises The Formulation Bar For Generics

With Pfizer’s blockbuster pain drug facing numerous generic challengers, the pharma gets FDA to agree not to accept any pregabalin ANDA that would include a “not less than” minimum level for R-isomer impurities; Pfizer’s patent certification arguments fall flat, however.

It arrived five months later than Pfizer Inc. had requested and denied a request that could have delayed generic challengers to its pain drug Lyrica (pregabalin) significantly, but the world’s biggest pharma still got a win Nov. 30 as FDA replied to a citizen petition by agreeing not to accept any ANDA for pregabalin that includes a “not less than” minimum level for R-isomer impurities.

Pfizer had filed its petition on June 6 against the background of a patent-infringement lawsuit pending against eight companies that...

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