Ranbaxy in deal with Alembic to market bioequivalent Pristiq in USA

The US subsidiary of India’s largest drugmaker, Ranbaxy Laboratories (AB: BO), which is majority owned by Japan’s Daiichi Sankyo (TYO: 4568 ), has entered into an in-licensing agreement with Indian firm Alembic Pharmaceuticals (BSE: 533573) to exclusively market desvenlafaxine base extended release tablets in the US health care system.

Alembic is the sponsor and manufacturer of the New Drug Application for desvenlafaxine base extended release tablets,  a bioequivalent version of innovator drug, Pristiq from global pharma behemoth Pfizer (NYSE: PFE). Pristiq generated US sales of $590 million (IMS – MAT January 2013).

Pristiq was also the subject of a patent challenge by Watson Pharmaceuticals (now known as Actavis) last year, when Pfizer filed a law suit to prevent the company from commercializing the product, resulting in a stay of final Food and Drug Administration approval of Watson's Abbreviated New Drug Application until August 29, 2015 or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities (The Pharma Letter June 26, 2012).