Impax confirms patent challenge of muscle spasm drug
IPXL | Quote | Chart | News | PowerRating -- Impax Laboratories, a technology based specialty pharmaceutical company, has announced that Eurand, Cephalon and Anesta have filed suit for patent infringement in the US District Court of Delaware based on the company's submission of abbreviated new drug application for cyclobenzaprine hydrochloride extended release capsules 15 and 30mg, generic of Amrix, to the FDA.
In connection with this abbreviated new drug application, Impax provided notice that its submission includes a paragraph IV certification stating the company believes its product does not infringe US patent, or the patent is invalid or unenforceable.
Amrix is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
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