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Glenmark Generics Limited has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) with a Paragraph IV Certification, to sell generic version of Azelaic Acid, gel 15% topical. Glenmark’s ANDA product is a generic version of Finacea, indicated for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea (chronic condition characterized by facial redness and pimples).
Shares of Glenmark have fallen about 0.6% to touch an intraday low of Rs 494.1 on BSE. Shares closed yesterday at Rs 497.5 yesterday on BSE.
According to the IMS health data for the twelve months ending September 30, 2012, Finacea had total US sales of approximately $95 million.
Intendis GmbH, Intraserv GmbH & Co. KG and Bayer Healthcare Pharmaceuticals Inc. filed suit against Glenmark Generics Limited and Glenmark Generics Inc. on March 14, 2013, in the United States District Court for the District of Delaware, seeking to prevent Glenmark from commercializing its ANDA product prior to the expiration of US Patent.
According to company statement, Glenmark believes it may be a first applicant to file an ANDA for the generic version of Finacea and may be entitled to 180 days of generic market exclusivity.
