Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), has entered into an in-licensing agreement with Alembic Pharmaceuticals Limited to exclusively market Desvenlafaxine Base Extended Release tablets in the US healthcare system.
Alembic Pharmaceuticals Limited is the sponsor and manufacturer of the New Drug Application (NDA) Desvenlafaxine Base Extended Release tablets. The product is a bioequivalent version of innovator drug, Pristiq by Pfizer Inc. The market size for Pristiq is US $ 590 Mn (IMS – MAT January 2013).
Desvenlafaxine Base Extended Release tablets is indicated for the treatment of major depressive disorder. The product will be available in 50 mg and 100 mg dosage strengths. Alembic has received the final approval from the US Food and Drug Administration (US FDA) and Ranbaxy expects the product to be available in the U.S. marketplace during the first quarter of 2013.
Commenting on the development, Bill Winter, vice president, Ranbaxy Trade Sales and Distribution, North America said, “Ranbaxy is pleased to partner with Alembic to offer a safe, effective, affordable generic alternative to the brand formulation much ahead of the patent expriation. We are committed to expand our portfolio of products offered in the US market for the benefit of patients, prescribers and the US healthcare system.”