Allergan, Inc. announced that the Federal Trade Commission's (FTC) Bureau of Competition has notified Allergan that it has officially closed its investigation to determine whether Allergan, Syntex International, Ltd. (now Roche Palo Alto), or any other person is engaging in unfair competition by monopolizing the market for ketorolac tromethamine ophthalmic solution by preventing or slowing generic competition to Acular (ketorolac tromethamine ophthalmic solution 0.5 per cent.
"We are pleased with the closing of this investigation by the FTC," said Douglas Ingram, Allergan's executive vice president. "With the closing of this investigation, all open issues involving our successful decision to protect our Acular intellectual property position have been entirely resolved."
The FTC's decision to close the investigation follows a December 29, 2003 ruling by the US District Court for the Northern District of California in favor of Allergan and Syntex International, and concluding that the patent covering Acular is valid, enforceable and infringed by a generic drug proposed to be manufactured by Apotex, Inc., Apotex Corp., and Novex Pharma Inc. (the "Apotex Defendants"). The FTC decision also follows the dismissal of a separate action brought by the Apotex Defendants against Allergan and Roche Palo Alto LLC. The antitrust action was based on allegations concerning the patent infringement lawsuit.
Acular is currently the number one prescribed ophthalmic non-steroidal anti-inflammatory in both the US and the rest of the world. Acular is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis and the treatment of post-operative inflammation in patients who have undergone cataract surgery.