Glenmark Generics Inc, USA (GGI), the United States subsidiary of GlenmarkGenerics Limited (GGL) has commenced marketing and distribution of cyclobenzaprine hydrochloride tablets in the US market.
Cyclobenzaprine hydrochloride tablets are the generic version of Flexeril tablets of McNeilPediatrics and are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Overall generic market sales for the product are approximately USD 36 million for the 12 month period ending March 2010, according to IMS Health Data.
The Abbreviated New Drug Application (ANDA) for cyclobenzaprine hydrochloride tablets was approved through Glenmark’s longstanding partnership with InvaGen Pharmaceuticals Inc. (InvaGen). The company will exclusively market and distribute the product while InvaGen will be responsible for their manufacture and supply. All profits on cyclobenzaprine hydrochloride tablets’ sale in the US will be shared between Glenmark and InvaGen.
In 2005, Glenmark and InvaGen entered into a collaboration agreement for the joint development, filing and marketing of several generic pharmaceutical products for the US market. The product list included a mixture of off-patent and patent-protected molecules. Glenmark’s current portfolio consists of 58 products authorized for distribution in the US marketplace. The company has over 50 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.