Bangalore, March 14, 2008: The US subsidiary of India-based Glenmark Pharmaceuticals has initiated the marketing and distribution of Nabumetone tablets and Hydroxyzine Hydrochloride tablets in the US market. Glenmark commenced shipping immediately upon final approval from the US Food and Drug Administration for an Abbreviated New Drug Application (ANDA) for Nabumetone tablets in 500mg and 750mg strengths; and Hydroxyzine Hydrochloride tablets in 10mg, 25mg and 50mg strengths, through its partnership with InvaGen Pharmaceuticals.

 

Nabumetone is a non-steroidal anti-inflammatory drug and is used to treat pain or inflammation caused by arthritis. According to IMS health data, for the 12-month period ending December 2007, the market size of Nabumetone was $97 million. Hydroxyzine belongs to a group of medicines called sedating antihistamines. Its main use is to help in the treatment of anxiety. According to IMS health data, the market size of Hydroxyzine Hydrochloride was $60 million.

 

Glenmark will exclusively market and distribute Nabumetone and Hydroxyzine Hydrochloride tablets while InvaGen will be responsible for their manufacture and supply. All development, regulatory costs and profits on Nabumetone and Hydroxyzine Hydrochloride tablets’ sale in the US will be shared equally between Glenmark and Invagen.

 

Glenmark and InvaGen entered into a collaboration agreement in 2006 for the joint development, filing and marketing of seven generic pharmaceutical products for the US market. The product list included a mixture of off-patent and patent-protected molecules with cumulative annual sales in the US of about $4.1 billion.