Teva, Impax neurology news
Teva's Cephalon Inc. subsidiary filed suit against Impax in the U.S. District Court for the District of Delaware alleging an ANDA from Impax for a generic version of pain drug Fentora fentanyl infringes U.S. Patent Nos. 6,200,604 B1, 6,974,590 B2, 7,862,832 B2 and 7,862,833 B2. The '604 and '590 patents cover methods of use for Fentora buccal oral tablets, while the '832 and '833 patents cover methods of administering fentanyl and opiates, respectively. The ANDA contains Paragraph IV certifications claiming that the patents are invalid, unenforceable and/or will not be infringed by the ANDA. The '604 and '590 patents expire March 26, 2019, while the '832 and '833 patents expire June 15, 2028.
In March, the court ruled an ANDA from Watson Pharmaceuticals Inc. (NYSE:WPI, Corona, Calif.) for a generic version of Fentora infringes a fifth patent from Cephalon, U.S. Patent No. 6,264,981. The patent covers a method for oral transmucosal drug delivery and expires in 2019. Also in March, the court ruled that the '604 and '590 patents are invalid for lack of enablement (see BioCentury, March 21 & March 28). ...