FDAnews Drug Daily Bulletin

The FDA tentatively approved Lupin Pharmaceuticals’ ANDA for a generic version of Forest Laboratories’ blockbuster antidepressant Lexapro. Lupin said it would launch the drug after it loses patent protection in 2012.

Lexapro (escitalopram oxalate) is a selective serotonin reuptake inhibitor approved for the treatment of major depressive disorder and general anxiety disorder. According to IMS Health, the product had $2.6 billion in sales for the 12 months ending in March. Lupin’s tentative approval covers the 10- and 20-mg tablets.

Lupin said it has 27 approved ANDAs, three tentatively approved ANDAs and 33 approvals pending at the FDA.

Several other generic companies have tentatively approved ANDAs for generic Lexapro for all dosage strengths — 5, 10 and 20 mg. Those firms include Teva Pharmaceutical, Actavis, Mylan and Dr. Reddy’s Laboratories.

Forest is involved in ongoing patent litigation over the drug with Caraco Pharmaceutical. Lexapro had sales of approximately $577.2 million for the company’s fourth quarter — a 9 percent increase over the same quarter last year.