The U.S. health regulator has approved the generic versions of Eli Lilly & Company’s Cymbalta, a drug to treat depression, paving the way for various Indian pharmaceutical companies to launch their products in the U.S. market.

“The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions,” the USFDA said in a statement.

Aurobindo Pharma, Dr. Reddy’s Laboratories, Lupin, Sun Pharma Global FZE, Teva Pharmaceuticals USA and Torrent Pharmaceuticals received FDA approval to market duloxetine in various strengths, it added.

“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” Acting Director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research Kathleen Uhl said. Generic prescription drugs approved by the FDA had the same high quality and strength as brand-name drugs, the health regulator said.

Our Mumbai Correspondent writes:

Lupin, on Thursday, said its U.S. subsidiary Lupin Pharmaceuticals Inc. (LPI) launched its Duloxetine Hydrochloride Delayed-release capsules in 20 mg, 30 mg and 60 mg strengths in the U.S. market after it received approval from the USFDA.

Duloxetine Hydrochloride Delayed-release capsules are used in the treatment of major depressive disorder (MDD), generalised anxiety disorder (GAD) and management of diabetic peripheral neuropathic pain (DPNP), the company said.

Cymbalta Delayed-Release capsules had annual U.S. sales of about $5.43 billion (as per IMS MAT September, 2013).

In a statement Sun Pharma said its subsidiary is eligible for shared 180-day marketing exclusivity in the U.S..