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Barr Laboratories challenges Alcon drug patents
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WOODCLIFF LAKE, N.J. — Barr Laboratories has initiated a challenge of patents listed by Alcon in connection with Alcon's Patanol, according to a press release from Barr Pharmaceuticals.
In June, Barr filed an abbreviated new drug application containing a paragraph 4 certification for a generic version of Patanol (0.1% olopatadine hydrochloride) with the U.S. Food and Drug Administration. Barr received notification of the application's acceptance for filing in September and thereafter notified the new drug application holder and patent owner, the release said.
On Oct. 24, Alcon announced that it had filed a patent infringement suit in the U.S. District Court in Indianapolis to prevent Barr from proceeding with commercialization. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Patanol is indicated for the treatment of allergic conjunctivitis. The drug had annual sales of approximately $320 million, based on IMS sales data ending August 2007, according to the release.
Barr Laboratories is a subsidiary of Barr Pharmaceuticals.