FDA Approves Mylan and Watson ANDAs for Generic Celebrex
The FDA granted final approval to Mylan and Watson for generic versions of Pfizer’s blockbuster arthritis drug Celebrex, allowing the companies to share 180-day exclusivity with Teva.
Both generics firms first launched their versions of Celebrex (celecoxib) in December as authorized generics using tentative FDA approval. Those launches came even as Mylan and Watson (now Actavis) continued to challenge an April 2014 FDA decision granting rival Teva first-filer exclusivity. Teva’s celecoxib launched Dec. 10 following a patent infringement settlement with Pfizer.
Mylan confirmed receiving final approval after a law firm representing the company in the case announced the FDA decision in a blog post.
The FDA shouldn’t have granted Teva first-filer exclusivity, Hyman, Phelps & McNamara says, because that exclusivity was based off invalidation of an initial patent that was later reissued. Rather, Mylan, Watson and Teva were each entitled to first-filer rights after their Hatch-Waxman challenges invalidated the reissued patent.
After a federal appeals court struck down the FDA decision of sole exclusivity in December, jurisdiction was returned to the agency, which granted final approval to the ANDAs. The two companies can now join in on the exclusivity period that started in December.
An Actavis spokesman said that the company will now be able to transition from the authorized generic provided by Pfizer to one it manufactures itself. The company is looking to switch by the end of the year.
Celebrex, which brought Pfizer $2.5 billion in sales last year, has been at the center of other controversies as well. Several lawsuits against Pfizer allege the company’s patent infringement settlements with ANDA filers amount to anticompetitive deals artificially prolonging market exclusivity. — Bryan Koenig