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Article: Spectrum announces initiation of Imitrex injection patent challenge.
- Article from:
- BIOTECH Patent News
- Article date:
- February 1, 2005
CopyrightCOPYRIGHT 2005 Biotech Patent News. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Spectrum Pharmaceuticals, Inc. (Irvine, CA) announced that it has initiated challenge of the patent listed by GlaxoSmithKline in connection with GlaxoSmithKline's Imitrex injection 6mg/0.5mL. The exclusivity afforded the patent listed in the Orange Book for Imitrex injection expires on February 6, 2009. Spectrum's Abbreviated New Application (ANDA) for sumatriptan succinate injection alleges that the Orange Book listed patent is invalid, unenforceable and/or would not be infringed by Spectrum's product.
Spectrum submitted its ANDA containing a Paragraph IV certification for a generic Imitrex injection product with the United States Food and Drug Administration ...