MONTVALE, NJ, Aug. 28 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that the U.S. District Court for the District of Delaware has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of U.S. Patent No. 4,663,318 ('the '318 patent') listed by Ortho McNeil Janssen in connection with Janssen's Razadyne(R) (galantamine hydrobromide), 4mg, 8mg and 12mg tablets. The Court's decision will effectively end the 30-month stay with respect to Barr's generic Razadyne tablets and Barr's generic Razadyne ER (galantamine hydrobromide), 8 mg, 16 mg and 24 mg extended release capsules.

In her ruling, District Court Judge Robinson found that the '318 patent is invalid for lack of enablement. Judge Robinson also denied Janssen's request for a Temporary Restraining Order which would have prevented Barr from marketing its product.

'We are very pleased with the Court's decision invalidating the patent on Razadyne and we intend to launch our generic Razadyne product immediately following receipt of final FDA approval, which we expect imminently,' said Christine Mundkur, CEO of Barr Laboratories, Inc. 'We also are evaluating our options regarding a launch of our generic version of Razadyne ER,' Mundkur continued.

Barr filed an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for Janssen's Razadyne (galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets on February 28, 2005, the first day that an ANDA containing a Paragraph IV certification could be submitted based on the expiration of the New Chemical Entity (NCE) exclusivity on the product. Following receipt of notification from the FDA of the application's acceptance for filing, Barr notified the New Drug Application (NDA) holder and patent owner of Barr's challenge to the patents protecting Razadyne. On June 15, 2005, Barr announced that Janssen had filed suit in the District Court for the District of Delaware, and the trial occurred in May 2007.

Janssen announced in its Form 10-Q filed with the U.S. Securities & Exchange Commission on May 10, 2005 that it had received Paragraph IV certifications for Razadyne tablets from six other generic pharmaceutical companies relating to the patents protecting Razadyne.

Barr also has a pending ANDA for Razadyne ER (galantamine hydrobromide), 8 mg, 16 mg and 24 mg extended release capsules. In its ANDA for that product, Barr certified that the '318 patent was invalid, unenforceable or not infringed. Barr subsequently amended its application to certify that an additional patent, U.S. Patent No. 7,160,559 ('the '559 patent'), which was not listed at the time Barr's original ANDA was filed, was invalid, unenforceable or not infringed. Janssen sued Barr in the District Court for the District of New Jersey on June 30, 2006. Pursuant to an Order in the case, Judge Robinson's decision in the District of Delaware will be given effect in the Razadyne ER litigation.