The product is the generic version of Pfizer’s Pristiq tablet,commonly used in the treatment of major depressive disorder (MDD) in adults.
Mylan says it is one of the first companies to file a complete ANDA containing a Paragraph IV certification for both pros and cons to have 180 days of exclusive marketing upon the approval.
The plaintiffs filed the lawsuit against Mylan in the US district court for district of delaware.
Currently, Mylan has 169 ANDAs, which need to get FDA approval.
Pristiq Tablets had total sales of $559.4m by the end of financial year, according to IMS Health.