Wednesday 5 November, 2008

Levetiracetam (Keppra): Mylan launched tablets in US market with generic exclusivity

Mylan has received final approval on Nov 4, 2008 from the USFDA for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma's Keppra®.
Robert J. Coury, Mylan's Vice Chairman and CEO, commented: "We are extremely pleased to be able to monetize another first-to-file opportunity and to offer a more affordable alternative for patients. In addition, after our very strong performance in the third quarter, the launch of Levetiracetam is another significant step toward the continued execution on our stated goals for 2009 and beyond." Following patent is listed for Levetiracetam in the Orange Book:
US4943639 (Expiry: Jan 14, 2009): Which covers Levetiracetam as product.
Mylan and UCB Societe Anonyme and UCB Pharma Inc. (collectively, UCB) previously had entered into an agreement to settle pending litigation relating to Levetiracetam Tablets. Pursuant to the settlement, Mylan was given the right to market the 250 mg, 500 mg and 750 mg strengths of Levetiracetam Tablets in the United States as early as Nov. 1, 2008, provided that UCB obtained pediatric exclusivity for Keppra and Mylan's ANDA obtained final approval from the FDA. UCB was granted pediatric exclusivity relating to the '639 patent, which extends to Jan. 14, 2009. Additional terms of the settlement are confidential.
Levetiracetam Tablets had U.S. sales of approximately $1 billion for the 12 months ending Sept. 30, 2008, for these three strengths.
Levitiracetam was approved by USFDA on Nov 30, 1999 for 250 mg, 500 mg and 750 mg strength tablets. However, 1g tablet strength was approved by USFDA on Jan 6, 2006

Mylan's press release Here

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