Barr receives U.S. approval for generic Razadyne tablets

Aug 28 2008

Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., received final approval from the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne (galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets. Barr intends to launch its generic Razadyne tablets product immediately.

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.

On June 15, 2005, Barr announced that Janssen had filed suit in the District Court of Delaware. 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 from six other generic pharmaceutical companies relating to the patents protecting Razadyne.

Earlier today, Barr 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 Razadyne (galantamine hydrobromide), 4mg, 8mg and 12mg tablets. The Court's decision effectively ended 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. Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has announced that it will appeal the decision.

Razadyne tablets had annual sales of approximately $102 million for the twelve months ending June 2008, according to IMS sales data.