Barr gets FDA clearance for generic Razadyne

Barr Laboratories has received final approval from the US Food and Drug Administration to manufacture and market a generic version of Ortho McNeil Janssen's RazadyneER (galantamine hydrobromide extended release capsules), 8mg, 16mg and 24mg. Barr also said that it is the first company to file an Abbreviated New Drug Application with the FDA containing a Paragraph IV certification for a generic version of the product, 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 R on March 1, 2006. It amended its ANDA on March 10, 2006. On July 6, 2006, it announced that Janssen had filed suit against the company in the US District Court of New Jersey asserting US Patent no 4,663,318. Barr subsequently amended its application to certify that a later listed patent, US patent no 7,160,559, 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. The latter subsequently filed a new suit asserting the '559 patent against Barr. On August 28 this year Barr said that the District Court for the District of Delaware had ruled in its favor in the challenge of the '318 patent. In her ruling, District Court Judge Robinson found that the '318 patent is invalid for lack of enablement.

Razadyne ER had annual sales of around $112.0 million for the 12 months ending June, according to IMS sales data.