BALTIMORE, June 11 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Ramipril capsules, 1.25 mg. 2.5 mg, 5 mg and 10 mg. Commercial shipments of the product have commenced.
Lupin's Ramipril capsules are the AB-rated generic equivalent of King Pharmaceutical's Altace(R) capsules, indicated for the treatment of hypertension. The brand product had annual sales of approximately $920 million for the twelve months ended December 2007, based on IMS Health sales data.
On June 5, 2008, in an effort to restrict Lupin's launch, King filed a motion for a temporary restraining order (TRO) and preliminary injunction against Lupin Pharmaceuticals, Inc. The hearing occurred June 10, 2008 and King'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 FDA as well as the decision from the court. Lupin has invested significant resources in trying to bring its generic equivalent of Altace(R) capsules to the market and we are very pleased to have prevailed on this additional motion from King."
Lupin was the first company to successfully challenge the brand and open the market to generic Altace(R) capsules. Because Lupin successfully challenged the patent and the TRO, it is not held back by the citizen's petition holding up other generics, whose timing of entry remains uncertain.
Commenting on the launch of Ramipril capsules, Bob Hoffman, Vice President of Sales and Marketing said, "This has been a hard fought battle and reflects Lupin's determination to continue its efforts to bringing quality, affordable generic alternatives to our customers."
Headquartered in Mumbai, India, Lupin Limited is an innovation led
transnational pharmaceutical company producing a wide r
|SOURCE Lupin Pharmaceuticals, Inc.|
Copyright©2008 PR Newswire.
All rights reserved