Endo, Teikoku Seiyaku, Watson neurology news

Endo, Teikoku and Watson settled patent infringement suits related to an ANDA submitted by Watson for a generic version of Endo's Lidoderm lidocaine topical patch. In 2010, Endo and Teikoku filed suit in the U.S. District Court for the District of Delaware alleging Watson's ANDA infringed U.S. Patent No. 5,827,529. In 2011, Endo filed another suit in the same court alleging Watson's ANDA infringed U.S. Patent Nos. 5,741,510; 6,096,333; 6,096,334; 5,536,263; and 6,361,790.

Under the settlement, Watson may not launch the generic until Sept. 15, 2013. Endo will provide Watson $12 million in branded Lidoderm product to sell each month from January 2013 to August 2013. If the ANDA is not approved by Dec. 31, 2013, Endo will provide Watson $6.7 million in branded Lidoderm product each month in 2014 that the ANDA is not approved. If the ANDA is not approved by Dec. 31, 2014, Endo will provide Watson $7.1 million in branded Lidoderm product each month from January 2015 to September 2015 that the ANDA is not approved. Watson will pay Endo a 25% royalty on gross profit of Watson's generic until another generic, including an authorized generic, enters the market. Endo may launch an authorized generic if a company besides Watson launches a generic Lidoderm or seven and a half months after Watson launches its generic. ...