Alcon Sues Barr Over Generic Patanol Filing

November 2, 2007

Barr Laboratories recently submitted an abbreviated new drug application (ANDA) for generic Patanol with Paragraph IV certifications, prompting Alcon Laboratories to file suit in the U.S. District Court for the Northern District of Illinois.

Patanol (olopatadine HCl) is indicated for treating the signs and symptoms of allergic conjunctivitis. The product had U.S. sales of approximately $320 million during the 12-month period that ended in August, according to Barr. The company submitted its ANDA in June and notified Alcon in September.

Unlike a previous ANDA filed by Apotex that challenged only the ’805 patent, which expires in 2015, Barr’s application also challenges the ’863 patent, which expires in 2010. Alcon sued Apotex in the same court in November 2006.

The ’805 patent covers “topical ophthalmic formulations for treating allergic eye diseases,” and the ’863 patent, which Alcon licenses from its raw material supplier, covers the drug’s pharmaceutical composition, according to Alcon’s Oct. 23 complaint.

The company has asked the court to rule that the FDA may not approve Barr’s product until the patents expire.