Celebrex Generics: Will Any Qualify For 180-Day Market Exclusivity?

Last patent covering Pfizer’s pain drug is a reissue of an earlier patent on which 180-day exclusivity has already been triggered; FDA has previously declined to award exclusivity to such patents.

Generic manufacturers will be able to launch their versions of Celebrex (celecoxib), Pfizer Inc.’s fourth top revenue generating drug, when it goes off patent in December 2015. But it’s uncertain whether FDA will award any of them 180 days of marketing exclusivity.

The unpredictability is the result of FDA’s apparent policy on reissue patents. Kurt Karst, of Hyman, Phelps & McNamara, noted...

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