Barr Pharmaceuticals has announced that its subsidiary, Barr Laboratories has received final approval from the FDA to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne, 4mg, 8mg and 12mg tablets. Barr intends to launch its generic Razadyne tablets product immediately.

Previously, Barr has filed an abbreviated new drug application (ANDA) with the FDA for Janssen's Razadyne (galantamine hydrobromide), 4mg, 8mg and 12mg tablets.

Following receipt of notification from the FDA of the application's acceptance for filing, Barr notified the new drug application holder and patent owner of Barr's challenge to the patents protecting Razadyne. On June 15, 2005, Barr has announced that Janssen had filed suit in the District Court of Delaware.

Later, Barr has announced that the US District Court of Delaware has ruled in favor of its subsidiary, Barr Laboratories in the challenge of US 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), 8mg, 16mg and 24mg extended release capsules.