BALTIMORE, June 11 Lupin Pharmaceuticals, Inc. announcedtoday that the U.S. Food and Drug Administration (FDA) has granted finalapproval for the Company's Abbreviated New Drug Application (ANDA) forRamipril capsules, 1.25 mg. 2.5 mg, 5 mg and 10 mg. Commercial shipments ofthe product have commenced.
Lupin's Ramipril capsules are the AB-rated generic equivalent of KingPharmaceutical's Altace(R) capsules, indicated for the treatment ofhypertension. The brand product had annual sales of approximately$920 million for the twelve months ended December 2007, based on IMS Healthsales data.
On June 5, 2008, in an effort to restrict Lupin's launch, King filed amotion for a temporary restraining order (TRO) and preliminary injunctionagainst Lupin Pharmaceuticals, Inc. The hearing occurred June 10, 2008 andKing's motion was denied.
Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals,Inc. said, "We are very excited with the grant of final approval from the FDAas well as the decision from the court. Lupin has invested significantresources in trying to bring its generic equivalent of Altace(R) capsules tothe market and we are very pleased to have prevailed on this additional motionfrom King."
Lupin was the first company to successfully challenge the brand and openthe market to generic Altace(R) capsules. Because Lupin successfullychallenged the patent and the TRO, it is not held back by the citizen'spetition holding up other generics, whose timing of entry remains uncertain.
Commenting on the launch of Ramipril capsules, Bob Hoffman, Vice Presidentof Sales and Marketing said, "This has been a hard fought battle and reflectsLupin's determination to continue its efforts to bringing quality, affordablegeneric alternatives to our customers."
Headquartered in Mumbai, India, Lupin Limited is an innovation ledtransnational pharmaceutical company producing a wide range of quality,affordable generic and branded formulations and APIs for the developed anddeveloping markets of the world. The Company has secured global leadershipposition in Anti-TB and Cephalosporins and has a significant presence in theareas of Cardiovasculars (prils and statins), Diabetology, Asthma and NSAIDs.
The Company's R&D endeavors have resulted in significant progress in itsNCE program. The Company's foray into New Drug Delivery Systems has resultedin the development of platform technologies that are being used to developvalue-added generic pharmaceuticals.
For the financial year ended March 2008, the Lupin's Revenues and Profitafter Tax were Rs.27,730 million (US$ 694 million) and Rs.4,083 million(US$ 102 million) respectively.
Lupin Pharmaceuticals, Inc. (LPI) is the U.S. wholly owned subsidiary ofLupin Limited, which is among the top six Pharmaceutical companies in India.Through its sales and marketing headquarters in Baltimore, Maryland, LupinPharmaceuticals, Inc. is dedicated to delivering high-quality, affordablegeneric medicines trusted by healthcare professionals and patients acrossgeographies. For more information, visit http://www.lupinpharmaceuticals.com.
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