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Allergan keeps generic ketorolac off market

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IRVINE, Calif. — Allergan and Syntex have won a patent infringement lawsuit to keep a generic version of Acular off market, the companies said in a press release.

In 2004, Allergan and Syntex won a patent infringement trial against Apotex and Novex, which had filed an Abbreviated New Drug Application to market a copy of Allergan’s non-steroidal anti-inflammatory drug Acular (ketorolac tromethamine ophthalmic solution 0.5%). Acular is currently approved for the temporary relief of ocular itching due to seasonal allergic conjunctivitis and the treatment of postoperative inflammation in patients who have undergone cataract surgery.

In early June the courts found that the Apotex application violated a patent held by Syntex and licensed by Allergan. As such, the earliest an Apotex application could be approved would be 2009, Allergan said in the release.