Glenmark Confirms Patent Challenge on Atovaquone & Proguanil Hydrochloride tablets

Date: 18 August 2009

 -   Glenmark is the Sole first-to-file applicant for this product.

- If the patent is successfully challenged, Glenmark will be entitled to a 180-day exclusivity

August 18, 2009 – Glenmark Generics Ltd confirmed that Smithkline Beecham Corporation (d/b/a Glaxosmithkline(GSK)) filed a patent infringement lawsuit on their U.S. subsidiary, Glenmark Generics Inc., USA (Glenmark) in the US District Court for the District of Delaware in connection with the Abbreviated New Drug Application (ANDA) filing for Atovaquone and Proguanil hydrochloride 250mg/100mg tablets. GSK currently markets their product as Malarone® in the United States and is indicated for the prevention and treatment of malaria. Total U.S. sales as reported by IMS Health for the 12 month period ending June 2009 were approximately USD 53 million.

Glenmark believes it is the sole first to file applicant on this product. Glenmark had earlier filed its ANDA containing a paragraph IV certification for its generic version of atovaquone and proguanil hydrochloride tablets with the U.S. Food & Drug Administration (FDA), and following receipt of the notice from the FDA that Glenmark's ANDA had been accepted for filing, notified the New Drug Application (NDA) holder and patent owner.

Smithkline Beecham Corporation’s lawsuit is part of the patent challenge process under the Hatch-Waxman Act. Based on the information published by the FDA, Glenmark believes it may be the first applicant to have filed an ANDA for this product with a paragraph IV certification. In the event that Glenmark successfully challenges the patent, Glenmark will be entitled to a 180-day exclusivity period. Glenmark’s current portfolio consists of over 40 products authorized for distribution in the U.S. marketplace. The Company has 45 ANDA’s pending for approval with the U.S. FDA. With this filing, Glenmark has four sole first-to-file products currently under litigation under the Hatch-Waxman Act. The other three products are Zetia® ( Ezetimibe), Tarka® (Trandolapril + Verapamil) and Cutivate® (Fluticasone lotion). Pending successful patent challenges, Glenmark will be entitled to sole marketing exclusivity for the 180 day period.

About Glenmark Generics Ltd.:

Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries. GGL has a strong base in Formulations development with teams operating out of laboratories in India and Latin America. The Company has a state-of-the-art manufacturing plant at Goa, India that is approved by US FDA, TPD (Canada), MHRA, UK and many other overseas regulatory authorities. GGL also markets over 45 APIs to more than 80 countries across the world and had over 30 USDMFs filed and/or approved along with several Canadian DMFs, EDMFs and CEPs/CoSs. [www.glenmark-generics.com]

About Glenmark Pharmaceuticals Ltd.:

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. The company is listed on India’s two premier stock exchanges, the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). It employs over 5500 people across its global operations over 85 countries. The Company is a leader in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc.], and metabolic disorders [Diabetes, Obesity, etc.]. The company has a significant presence in branded generics markets across emerging economies including India. In December 2008, Glenmark bagged the prestigious SCRIP award for the “Best Pharma Company in the World – SME” and the “Best Company in Emerging Markets” at the SCRIP Awards 2008 in London. For more information on GPL, log on to http://www.glenmarkpharma.com/

For further information, please contact:

Jason D’Souza | Medha Satam

Glenmark, Mumbai, India

Tel: [+91 22] 40189919 / 40189993 Email : connect@glenmark-generics.com

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