BioCentury
ARTICLE | Company News

Cipher, Napp Pharmaceutical Group Ltd., Purdue Pharma drug delivery, neurology news

November 9, 2009 8:00 AM UTC

Purdue and Napp sued Cipher in the U.S. District Court for the Eastern District of Virginia, alleging that Cipher's Cip-Tramadol ER, an extended release tramadol capsule, infringes their U.S. Patent Nos. 6,254,887 and 7,074,430 covering controlled-release tramadol. Biovail Corp. (TSX:BVF; NYSE:BVF, Mississauga, Ontario) and Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) have licenses from Purdue and Napp for Ultram ER controlled-release tramadol. In February, FDA granted tentative approval of Napp's 505(b)(2) NDA for Cip-Tramadol, pending expiration of exclusivity for Ultram ER in 2014. Cipher subsequently filed a paragraph IV certification against the '887 patent, stating the patent was invalid and/or will not be infringed. Purdue and Napp are seeking to delay the final approval and marketing of Cip-Tramadol ER until the patents expire in 2014 (see BioCentury, March 3). ...