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the first-to-file drug prasugrel: hec pharm was sued by eli lilly
author:    time: 2014-07-11   browse: 1287

on july 8, 2014, hec pharm received a complaint from united states district court southern district of indiana about eli lilly and company et al.(collectively, “plaintiffs”) for their complaint against defendants hec pharm co., ltd. et al (collectively, “defendants”).plaintiffs asserted the infringement of u.s. patent nos.  ("medicinal compositions containing aspirin," issued march 26, 2013) following a paragraph iv certification as part of defendants' filing of an anda to manufacture a generic version of lilly's effient? (prasugrel hydrochloride, to be used in combination with aspirin for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome).

the ftf(first-to-file) anda application of prasugrel hydrochloride was submitted by hec pharm and its subsidiary sunshine lake pharma to usfda on july 10, 2013, which is the first day that the generic company can submit an anda for lilly's effient?.

hec pharm has done a full investigation in the early stage of development, meanwhile, the us attorney representing for hec pharm believes that the patent is invalid or unenforceable. hec pharm will actively respond to the action in determining the outcome of the litigation.

ftf generic drug

in 1984, the united states issued hatch-waxman act to encourage generic manufactures to challenge the brand drug patents and break the brand monopoly, thus reduce the economic burden of patients. the first successful challenger, which is called the ftf generic drug, will be awarded with 180 days market exclusivity for generic. to be the ftf generic drug, the first one to submit the anda application and a paragraph iv certification are needed.

paragraph iv certification

paragraph iv certification provides opportunities for generic manufacturers to launch the generic version of brand drug before the expiration of brand drug’s patents listed in orange book, which requires generics manufacturers to certify that patents in orange book are invalid, unenforceable, and/or the generic drug seeking to be approved will not infringe such patents.

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