FDA approves generic Arthrotec

FDA has approved Watson’s generic diclofenac sodium and misoprostol delayed-release tablets (Arthrotec, G.D. Searle, a subsidiary of Pfizer), indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.

According to a company press release, Watson plans to launch the product in the fourth quarter of 2012.

For the 12 months ending May 31, 2012, Arthrotec had total US sales of approximately $130 million according to IMS Health data.

“Arthrotec is a brand name combination product of diclofenac and misoprostol,” said Formulary advisor James M. Wooten, PharmD, associate professor, department of medicine, section of clinical pharmacology, University of Missouri-Kansas City. “The misoprostol is intended to alleviate the ulcer producing potential of diclofenac. Those patients well controlled on the brand name Arthrotec may receive a price break with FDA’s approval of the generic product. However, until the price is announced by the generic company it is difficult to predict the extent of the price reduction.”