Generic drug sale blocked until 2009

Irvine, CA-A federal appellate court has blocked the largest Canadian-owned pharmaceutical company from manufacturing and selling a generic version of Allergan's ketorolac tromethamine ophthalmic solution 0.5% (Acular).

The ruling, by the United States Court of Appeals for the Federal Circuit, upholds a lower-court ruling in favor of Allergan and Roche Palo Alto LLC (formerly known as Syntex). That ruling found that Apotex Inc., Apotex Corp., and Novex Pharma had infringed a valid and enforceable patent owned by Roche Palo Alto and licensed to Allergan.

The solution is used to treat ocular itching related to seasonal allergic conjunctivitis or for the treatment of postoperative inflammation following cataract surgery.

The companies are prevented from making any preparations that make, use, sell, or offer for sale ketorolac tromethamine ophthalmic solution 0.5% in the United States.

Apotex Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned manufacturer of prescription drugs. Novex Pharma is part of the Apotex Group of Companies.