Cephalon (CEPH) and Eurand (EURX) File Infringement Suit Against Mylan (MYL) and Barr Pharma (BRL)
Cephalon, Inc. (Nasdaq: CEPH) and Eurand, Inc. (Nasdaq: EURX) have filed a lawsuit in U.S. District Court in Delaware against Mylan Pharmaceuticals, Inc. (NYSE: MYL) and its subsidiary, Mylan, Inc., and Barr Pharmaceuticals, Inc. (NYSE: BRL) and its subsidiary, Barr Laboratories, Inc., for infringement of Eurand's U.S. Patent Number 7,387,793. This patent claims extended-release formulations containing the muscle relaxant cyclobenzaprine, including AMRIX(R) (Cyclobenzaprine Hydrochloride Extended-Release Capsules) and expires February 26, 2025.
The lawsuit is based upon Abbreviated New Drug Applications (ANDAs) filed by Mylan and Barr, each seeking U.S. Food and Drug Administration (FDA) approval for a generic equivalent of the 15 mg and 30 mg strengths of AMRIX to be sold in the United States. The Mylan ANDA alleges that the AMRIX patent will not be infringed by its manufacture, use or sale of the product described in its ANDA and reserves its right to challenge the validity and/or enforceability of the AMRIX patent. The Barr ANDA alleges that the AMRIX patent is invalid, unenforceable and/or will not be infringed by its manufacture, use or sale of the product described in its ANDA. AMRIX was approved by the FDA in February 2007 for short-term use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
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.[SM]
The lawsuit is based upon Abbreviated New Drug Applications (ANDAs) filed by Mylan and Barr, each seeking U.S. Food and Drug Administration (FDA) approval for a generic equivalent of the 15 mg and 30 mg strengths of AMRIX to be sold in the United States. The Mylan ANDA alleges that the AMRIX patent will not be infringed by its manufacture, use or sale of the product described in its ANDA and reserves its right to challenge the validity and/or enforceability of the AMRIX patent. The Barr ANDA alleges that the AMRIX patent is invalid, unenforceable and/or will not be infringed by its manufacture, use or sale of the product described in its ANDA. AMRIX was approved by the FDA in February 2007 for short-term use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
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.[SM]
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