Allergan plc issued the following statement regarding ongoing litigation on patents related to Namenda XR (memantine hydrochloride) extended release capsules following announcement of FDA final ANDA approval by Lupin.

"As announced on September 10, 2015, Allergan's Forest Laboratories subsidiaries and its licensors announced a settlement agreement regarding their Namenda XR ANDA litigation with Amneal Pharmaceuticals as first filer and granted a licensed entry date of January 31, 2020. In addition, the company has settled with all other Namenda XR ANDA defendants, including Lupin Limited and Lupin Pharmaceuticals, Inc., and the company has not announced any earlier licensed entry dates.

One of the licensed patent families covering Namenda XR has been held invalid by the Federal District Court for the District of Delaware. That decision is under appeal to the US Court of Appeals for the Federal Circuit. The company will defend the validity of these patents on appeal and believes that its arguments on appeal are substantial and meritorious.

If the district court ruling on these patents is upheld, there is a possibility that generic entry for Namenda XR could occur following an adverse Court of Appeals decision."