IMPAX Lab announced today that innovator Eurand, Inc., Cephalon, Inc., and Anesta AG have filed suit for patent infringement in the United States District Court for the District of Delaware based on the Company's submission of Abbreviated New Drug Application (“ANDA”) for Cyclobenzaprine hydrochloride Extended Release capsules (15 and 30 mg), generic of Amrix(R), to the Food and Drug Administration. Innovator alleged infringement of following Orange Book listed patent:
US7387793 (Expiry: February 26, 2025): Which covers a multi-particulate pharmaceutical dosage form of a skeletal muscle relaxant providing a modified release profile comprising a population of extended release beads, wherein said extended release beads comprise an active-containing core particle comprising a skeletal muscle relaxant selected from the group consisting of cyclobenzaprine, pharmaceutically acceptable salts or derivatives thereof and mixtures thereof; and an extended release coating comprising a water insoluble polymer membrane surrounding said core, wherein said dosage form when dissolution tested using United States Pharmacopoeia Apparatus 2 (paddles @ 50 rpm) in 900 mL of 0.1N HCl at 37.degree. C. exhibits a drug release profile substantially corresponding to the following pattern: after 2 hours, no more than about 40% of the total active is released; after 4 hours, from about 40-65% of the total active is released after 8 hours, from about 60-85% of the total active is released; wherein said dosage form provides therapeutically effective plasma concentration over a period of 24 hours to treat muscle spasm associated with painful musculoskeletal conditions when administered to a patient in need thereof; and wherein said water insoluble polymer membrane comprises a water insoluble polymer selected from the group consisting of ethers of cellulose, esters of cellulose, cellulose acetate, ethyl cellulose, polyvinyl acetate, neutral copolymers based on ethylacrylate and methylmethacrylate, copolymers of acrylic and methacrylic acid esters with quaternary ammonium groups, pH-insensitive ammonio methacrylic acid copolymers, and mixtures thereof; and a plasticizer selected from the group consisting of triacetin, tributyl citrate, tri-ethyl citrate, acetyl tri-n-butyl citrate, diethyl phthalate, dibutyl sebacate, polyethylene glycol, polypropylene glycol, castor oil, acetylated mono- and di-glycerides and mixtures thereof.‘793 patent is listed for 15 mg and 30 mg strengths of AMRIX (Cyclobenzaprine hydrochloride ER capsules). Eurand developed AMRIX based on its patented and proprietary drug delivery formulation technologies. Cephalon is the exclusive licensee and marketer of AMRIX in the United States. USFDA approved innovator’s product on Feb 1, 2007.Further, Cephalon has 3 years of marketing exclusivity (New dosage Form exclusivity) preventing USFDA approval of a generic version of AMRIX until February 1, 2010.
Innovator has earlier sued Mylan Pharma and Barr for the infringement of above patent in Delaware District Court in November, 2008. The generic players filed Para IV on August 11, 2008.
US7387793 (Expiry: February 26, 2025): Which covers a multi-particulate pharmaceutical dosage form of a skeletal muscle relaxant providing a modified release profile comprising a population of extended release beads, wherein said extended release beads comprise an active-containing core particle comprising a skeletal muscle relaxant selected from the group consisting of cyclobenzaprine, pharmaceutically acceptable salts or derivatives thereof and mixtures thereof; and an extended release coating comprising a water insoluble polymer membrane surrounding said core, wherein said dosage form when dissolution tested using United States Pharmacopoeia Apparatus 2 (paddles @ 50 rpm) in 900 mL of 0.1N HCl at 37.degree. C. exhibits a drug release profile substantially corresponding to the following pattern: after 2 hours, no more than about 40% of the total active is released; after 4 hours, from about 40-65% of the total active is released after 8 hours, from about 60-85% of the total active is released; wherein said dosage form provides therapeutically effective plasma concentration over a period of 24 hours to treat muscle spasm associated with painful musculoskeletal conditions when administered to a patient in need thereof; and wherein said water insoluble polymer membrane comprises a water insoluble polymer selected from the group consisting of ethers of cellulose, esters of cellulose, cellulose acetate, ethyl cellulose, polyvinyl acetate, neutral copolymers based on ethylacrylate and methylmethacrylate, copolymers of acrylic and methacrylic acid esters with quaternary ammonium groups, pH-insensitive ammonio methacrylic acid copolymers, and mixtures thereof; and a plasticizer selected from the group consisting of triacetin, tributyl citrate, tri-ethyl citrate, acetyl tri-n-butyl citrate, diethyl phthalate, dibutyl sebacate, polyethylene glycol, polypropylene glycol, castor oil, acetylated mono- and di-glycerides and mixtures thereof.‘793 patent is listed for 15 mg and 30 mg strengths of AMRIX (Cyclobenzaprine hydrochloride ER capsules). Eurand developed AMRIX based on its patented and proprietary drug delivery formulation technologies. Cephalon is the exclusive licensee and marketer of AMRIX in the United States. USFDA approved innovator’s product on Feb 1, 2007.Further, Cephalon has 3 years of marketing exclusivity (New dosage Form exclusivity) preventing USFDA approval of a generic version of AMRIX until February 1, 2010.
Innovator has earlier sued Mylan Pharma and Barr for the infringement of above patent in Delaware District Court in November, 2008. The generic players filed Para IV on August 11, 2008.
Amrix(R) 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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