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...