Barr Pharmaceuticals, Inc announced that its subsidiary, Barr Laboratories, Inc, received final approval from the US 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.
The U S District Court for the District of Delaware has ruled in favour of Barr's 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.
Barr Pharmaceuticals, Inc is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.