HomeGlenmark Confirms Patent Challenge of Fluticasone Lotion
Date: 17 December 2008
Glenmark Generics Ltd’s US subsidiary(GGI) confirmed Nycomed US ("Nycomed") filed a patent infringement lawsuit on 12 Dec 2008 in the U.S. District Court, Eastern District Court of New York regarding Glenmark's Abbreviated New Drug Application ("ANDA") for its Fluticasone Propionate 0.05% Lotion product. Nycomed currently markets its Fluticasone product as CUTIVATE®.
Glenmark filed its ANDA containing a paragraph IV certification for a generic version of Fluticasone Propionate lotion 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, Glenmark notified the New Drug Application (NDA) holder and patent owner.
Nycomed'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 Nycomed's patent, Glenmark will be entitled to a 180-day exclusivity period.
CUTIVATE (Fluticasone Propionate) 0.05% Lotion had annual sales of approximately USD 33 million in the U.S., based on IMS sales data ending September 2008.
With this filing, Glenmark has three products currently under litigation under the Hatch-Waxman Act. The earlier two molecules are Ezetimibe and Trandolapril+Verapamil Hydrochloride . On successful patent challenges, Glenmark will be entitled for the 180 days exclusivity.
About Glenmark Generics Ltd. (GGL) 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. Its shares are listed on India’s two large 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 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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