Table of Contents
PITTSBURGH and PARSIPPANY, N.J. — Mylan Inc. and Watson Pharmaceuticals Inc. have launched cyclobenzaprine hydrochloride extended-release capsules, a muscle relaxer, in strengths of 15 mg and 30 mg.
Pittsburgh-based Mylan said it’s the first company to have filed a substantially complete abbreviated new drug applications (ANDA) containing a Paragraph IV certification for cyclobenzaprine hydrochloride extended-release capsules and was awarded 180 days of marketing exclusivity for the product, which is being rolled out by its Mylan Pharmaceuticals subsidiary.
Cyclobenzaprine HCl ER capsules are the generic version of Cephalon Inc.’s Amrix capsules, which had U.S. sales of about $125 million for the 12 months ended March 31, according to IMS Health figures reported by Mylan and Watson.
Parsippany, N.J.-based Watson said its Watson Pharma Inc. unit has introduced an authorized generic version of Amrix as part of an agreement with Anesta AG, a subsidiary of Cephalon.
Under the terms of the nonexclusive sales agent agreement, Anesta manufactures and supplies Watson with all dosage strengths of the authorized generic product. Watson said it markets and distributes the product in the United States on behalf of Anesta and will receive payments based on sales of the product.
Amrix is approved for use along with rest and physical therapy to help control muscle spasm associated with acute, painful musculoskeletal conditions, according to Watson.
