"We believe our Orange Book-listed patent provides coverage for AMRIX until 2025 and we intend to work diligently with Cephalon to protect this important product," said Manya S. Deehr, Eurand's Chief Legal Officer.
The filing of this lawsuit is provided for by the Hatch-Waxman Act, a federal statute governing certain aspects of generic drug approvals. Under that statute, the filing of the lawsuit stays any FDA approval of the Mylan and Barr ANDAs until the earlier of a district court judgment in favor of Mylan or Barr or 30 months from the October 2008 receipt of the Mylan and Barr Paragraph IV certification letters.
Eurand developed AMRIX based on its patented and proprietary drug delivery formulation technologies. Cephalon is the exclusive licensee and marketer of AMRIX in the United States. Concurrent with the patent protection described above, Cephalon has a three-year period of marketing exclusivity preventing FDA approval of a generic version of AMRIX until February 2010.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. The company's European headquarters are located in Maisons-Alfort, France.
The company's proprietary products in the United States include:
|SOURCE Cephalon, Inc.|
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