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 ER (galantamine hydrobromide extended release capsules), eq. to 8 mg, 16 mg and 24 mg.
Barr also announced that it is the first company to file an Abbreviated New Drug Application (ANDA) with the US Food & Drug Administration (FDA) containing a paragraph IV certification for a generic version of Razadyne ER capsules, and therefore is entitled to 180-days of marketing exclusivity, as provided for under the Hatch Waxman Act. The company intends to launch its product shortly.
Barr filed its ANDA with the FDA containing a paragraph IV certification for the 8 mg eq. capsule strength of Razadyne ER on March 1, 2006. Barr amended its ANDA on March 10, 2006 to include the 16 mg eq. and 24 mg eq. capsule strengths in its filing. Following receipt of the notice from the FDA that Barr's ANDA was accepted for filing, Barr notified the New Drug Application (NDA) holder and patent owner.
On July 6, 2006, Barr announced that Janssen had filed suit against the company in the US District Court of New Jersey asserting US patent No 4,663,318 (the '318 patent) against Barr. Barr subsequently amended its application to certify that a later listed patent, US 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, and provided notice of this to Janssen. Janssen subsequently filed a new suit asserting the '559 patent against Barr.
On August 28, 2008, Barr announced that the US District Court for the District of Delaware had ruled in Barr's favour in the challenge of the '318 patent listed by Ortho McNeil Janssen in connection with Janssen's Razadyne tablets.
In her ruling, District Court Judge Robinson found that the '318 patent is invalid for lack of enablement. Pursuant to an order in the case pending in the District of New Jersey, Judge Robinson's decision in the District of Delaware was given effect in the Razadyne ER litigation. Therefore, the decision regarding the '318 patent effectively ended the 30-month stay with respect to Barr's generic Razadyne ER (galantamine hydrobromide), 8 mg, 16 mg and 24 mg extended release capsules.
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.