The lawsuit covers some or all of US patent Nos. 5,061,703; 8,039,009; 8,168,209; 8,173,708; 8,283,379; 8,329,752; 8,362,085; and 8,598,233.
Forest licenses the ‘703 patent, which expires in April 2015, from Merz, and the ‘209, ‘708, ‘379, ‘752, ‘085 and ‘233 patents, which expire in November 2025, from Adamas. Forest owns the ‘009 patent, which expires in March 2029.
The defendants named in the lawsuit include Sun Pharma Global, Teva Pharmaceuticals USA, Wockhardt Bio, and related companies and subsidiaries.
Forest received notification from these companies that they had filed abbreviated new drug applications (ANDAs) with Paragraph IV certifications seeking approval to market generic versions of NAMENDA XR before the expiration of some or all of the patents.
The aforementioned lawsuit was commenced before the expiration of forty-five days from the date of receipt of each notification letter, which triggered an automatic stay of approval of the applicable ANDAs that expires no earlier than June 2016 (unless the court issues a decision adverse to Forest, Merz, and Adamas earlier).