Glenmark Generics Inc, USA (GGI), the US subsidiary of Glenmark Generics Limited and a leading company in the manufacture, marketing and distribution of high-quality, low-cost generic pharmaceutical products in the US, initiated the launch of fosinopril sodium and hydrochlorothiazide tablets in the US market.

Fosinopril sodium and hydrochlorothiazide (HCTZ) tablets are available in both 10mg/12.5mg and 20mg/12.5mg strengths and are indicated for the treatment of hypertension. Glenmark's product is the AB rated therapeutic equivalent of Bristol Myers Squibb's Monopril-HCT. Overall generic market sales for the product is approximately USD 10 million for the 12 month period ending March 2009, according to IMS Health Data.

Terrance Coughlin, chief executive officer, Glenmark Generics Limited commented, "Glenmark is prepared to commence shipping based on today's final approval from the US FDA. As fosinopril + HCTZ is a maintenance medication, we are very pleased with this approval as it gives us the chance to provide customers with guaranteed and uninterrupted supply which they may not have been getting in the past. We anticipate a successful launch considering the limited competitive landscape coupled with the niche positioning of this product."

The Abbreviated New Drug Application (ANDA) for fosinopril sodium and hydrochlorothiazide 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 development, regulatory costs and profits on fosinopril sodium and hydrochlorothiazide tablets' sale in the US will be shared equally between Glenmark and Invagen.

In fiscal year 2006, 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.

This recent approval expands Glenmark's portfolio to 46 generic products authorized for distribution in the US market. The company has over 40 ANDAs pending approval with the US FDA.