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.”
About Lupin
Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world. The Company has secured global leadership position in Anti-TB and Cephalosporins and has a significant presence in the areas of Cardiovasculars (prils and statins), Diabetology, Asthma and NSAIDs.
The Company’s R&D endeavors have resulted in significant progress in its NCE program. The Company’s foray into New Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.
For the financial year ended March 2008, the Lupin’s Revenues and Profit after 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 of Lupin Limited, which is among the top six Pharmaceutical companies in India. Through its sales and marketing headquarters in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management’s expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release.
CONTACT: Edith St-Hilaire, Senior Marketing Manager of Lupin
Pharmaceuticals, Inc., +1-410-576-2000 Ext. 207
Web site: http://www.lupinpharmaceuticals.com/
