Glenmark settles Para IV litigation with Forest Labs for generic Savella

Glenmark Pharmaceuticals has entered into a settlement agreement with Forest Laboratories and Royalty Pharma Collection Trust to settle and dismiss the outstanding patent litigation related to Glenmark’s abbreviated new drug application (ANDA) for milnacipran hydrochloride 12.5 mg, 25 mg, 50 mg, and 100 mg tablets - the generic version of Forest’s Savella.
 
As per the agreement, Glenmark will have the option to market and distribute its milnacipran hydrochloride tablets or an authorised generic version of Savella tablets. Other terms of the settlement agreement are confidential.
 
Savella is indicated for the management of fibromyalgia - a rheumatic condition characterised by muscular or musculoskeletal pain with stiffness and localised tenderness at specific points on the body. According to IMS Health sales data for the 12 month period ending October 2015, Savella achieved annual sales of approximately $ 134.7 million.
   
Glenmark’s current portfolio consists of 103 products authorised for distribution in the US marketplace and 63 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.