Shire, TWi Pharmaceuticals, Par Pharmaceutical neurology news
Shire, TWi and Par Pharmaceutical's Anchen Pharmaceuticals Inc. subsidiary settled a patent infringement suit related to an ANDA submitted by TWi for a generic version of Shire's ADHD drug Intuniv guanfacine extended release. Under the settlement, Anchen will receive a license to market the drug on July 1, 2016, while TWi, Anchen's authorized distributor and filing agent, will receive a license to manufacture the drug. Shire will receive a royalty on sales of the generic and may authorize Anchen to sell an generic version of Intuniv supplied by Shire. Anchen and TWi agreed to a consent judgment confirming that their proposed generic infringes U.S. Patent Nos. 6,287,599 and 6,811,794, and that the patents are valid and enforceable. The patents cover sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles and expire in December 2020 and July 2022, respectively.
In 2010, Shire filed suit in the U.S. District Court for the District of Delaware alleging TWi's ANDA infringed the patents. Par acquired Anchen in 2011. ...