Opinion ID: 209997
Heading Depth: 2
Heading Rank: 1

Heading: Forest's NDA for Lexapro®

Text: Forest holds an approved NDA for its drug Lexapro®, which is used to treat depression and generalized anxiety disorder. Forest currently faces no generic competition for Lexapro®. Forest Labs., Inc. v. Ivax Pharms., Inc., 438 F.Supp.2d 479, 494 (D.Del.2006). As part of the process for filing its Lexapro® NDA, Forest listed two patents in the FDA's Orange Book, namely: U.S. Patent Nos. Re. 34,712 (the '712 patent) and 6,916,941 (the '941 patent). The '712 patent includes claims covering substantially pure forms of escitalopram, the active ingredient of Lexapro®. The '941 patent generally covers crystalline particles of escitalopram oxate of a particular size range, as well as dosage forms containing particles of this size range, and methods of manufacturing particles in this size range. The '712 patent expires in 2012; the '941 patent expires in 2023.