New Delhi, Mar 13 (UNI) Glenmark Pharmaceuticals Ltd (Glenmark) today said its US subsidiary Glenmark Pharmaceuticals Inc (GPI), has undertaken the marketing and distribution of Nabumetone and Hydroxyzine Hydrochloride tablets in the US market.
Glenmark has commenced shipping of Nabumetone tablets in 500mg and 750mg strengths and Hydroxyzine Hydrochloride tablets in 10mg, 25mg and 50mg strengths, through its partnership with InvaGen Pharmaceuticals Inc (Invagen) immediately after receiving approval from the US Food and Drug Administration (ANDA).
The Company 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 hydrichloride tablets's sale in the US will be shared equally between Glenmark and Invagen.
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 dollars.
Hydroxyzine belongs to a group of medicines called sedating antihistamines. Hydrbxyzine's main use is to help in the treatment of anxiety. According to IMS Health data, for the 12 month period ending December 2007, the market size of Hydroxyzine Hydrochloride was 60 million dollars.
In FY 06, Glenmark and InvaGen entered into a collaboration agreement 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 dollars.
This recent approval expands Glenmark's portfolio to 28 generic products for the US market. The Company has over 35 ANDAs undergoing review with the US FDA for approval and launch.
UNI PDT DB1348