HomeGlenmark receives tentative approval from US-FDA for cholesterol-lowering agent Ezetimibe
Date: 27 April 2009
§ This is the first tentative approval for Ezetimibe granted by USFDA
§ Glenmark believes it has first-to-file status on Ezetimibe, providing a potential for 180 days of marketing exclusivity
Glenmark Generics Ltd’s US subsidiary(GGI) announced that the US Food and Drug Administration (US-FDA) has granted tentative approval for the generic version of Schering Plough and MSP Singapore Company LLC’s hypercholesterolemia treatment Zetia®(ezetimibe).
The tentative approval granted by the US-FDA is for the 10 mg tablets of Ezetimibe and constitutes the first tentative approval granted by the FDA for a generic version of the drug. Glenmark believes that it has first-to-file status on Ezetimibe tablets, thereby providing a potential of 180-days of marketing exclusivity.
Glenmark would have the earliest opportunity among any competitors to gain market share from the branded product Zetia® which achieved sales of USD 1.5 billion in 2008. Product launch is dependent upon receipt of final approval of its ANDA from the US FDA and resolution of litigation currently pending in the US district court of New Jersey.
The Company will be vertically integrated by manufacturing the active pharmaceutical ingredient for its Ezetimibe tablets.
Glenmark filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA) seeking regulatory approval to market a generic version of Ezetimibe on October 25, 2006. Glenmark’s ANDA included a Paragraph IV certification with respect to patents listed by Schering in the FDA “Orange Book.”
Glenmark’s current portfolio consists of around 40 generic products authorized for distribution in the U.S. market. The Company currently has over 40 ANDA’s filed with the U.S. FDA pending approval. 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.
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 India 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 is in the process of creating marketing front-ends for the launch of its proprietary products in the future. Glenmark’s first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals. Oglemilast is presently undergoing Phase II clinical trials in the US. GRC 6211 has been out-licensed to Eli Lilly & company.
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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