Mylan (MYL) may begin manufacturing a generic version of the blood glucose lowering drug Fortamet starting Aug. 1, according to an agreement reached between the generic drug maker and both Shionogi Pharma and Andrx Pharmaceuticals, which was previously known as Watson Pharmaceuticals until it changed its name on Jan. 1 to Actavis (AGN).
The agreement settles a patent infringement lawsuit that the two had brought against Mylan for seeking to manufacture and sell a generic version of the drug prior to the expiration of the patents protecting it.
As a result of the settlement, Mylan will be able to manufacture 500 mg and 1000 mg extended-release metformin hydrochloride tablets, the generic version of Fortamet, which had sales of approximately $125 million in the U.S. for the 12 months ending Sept. 30, 2012. All pending litigation between the parties will be dismissed, and Mylan will be allowed to manufacture the treatment before Aug. 1 if certain undisclosed conditions are met. The rest of the terms were not released either.
Fortamet is used by patients with Type 2 diabetes mellitus, which Shiongi markets in the U.S. under the brand name Fortamet.
