Cephalon and Eurand Announce Notification of Generic Filing for Cyclobenzaprine Hydrochloride Extended-Releas... ( FRAZER Pa. and PHILADELPHIA Oct. ...)

Cephalon and Eurand Announce Notification of Generic Filing for Cyclobenzaprine Hydrochloride Extended-Release Capsules

Date:10/21/2008

FRAZER, Pa. and PHILADELPHIA, Oct. 21 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) and Eurand NV (Nasdaq: EURX) today announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2008 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Mylan Pharmaceuticals, Inc., requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of AMRIX(R) (Cyclobenzaprine Hydrochloride Extended-Release Capsules). In the Notice Letter, Mylan alleges that the U.S. Patent Number 7,387,793, entitled "Modified Release Dosage Forms of Skeletal Muscle Relaxants," issued to Eurand is invalid, unenforceable and/or will not be infringed by Mylan's manufacture, use or sale of the product described in Mylan's ANDA submission. The Eurand patent covers extended-release formulations containing the muscle relaxant cyclobenzaprine and expires on February 26, 2025. Cephalon has a three-year period of marketing exclusivity for AMRIX that extends until February 2010.

Eurand, the developer of AMRIX, and Cephalon, the exclusive licensee and marketer of AMRIX in the United States, currently are reviewing the Notice Letter. By statute, if Eurand initiates a patent infringement lawsuit against Mylan within 45 days of the Notice Date, then the FDA would be automatically precluded from approving the Mylan ANDA until the earlier of a district court decision finding the patent invalid or not infringed or 30 months from the receipt of the Noti
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SOURCE Cephalon, Inc.
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Cephalon and Eurand Announce Notification of Generic Filing for Cyclobenzaprine Hydrochloride Extended-Releas...( FRAZER Pa. and PHILADELPHIA Oct. ...)