Monday 20 June 2016

Total 8 ANDA filers are in the First TO File Race for TICAGRELOR tablet 60MG and 90MG (Innovator name: BRILINTA)

Watson, HEC, Apotex, Amneal, InvaGen,  Mylan, Prinston and Sigmapharma are the defendants in TICAGRELOR tablet 60MG and 90MG
(Innovator name: BRILINTA) patent litigation case where ASTRAZENECA LP-Innovator company is Plaintiffs has registered Patent Infrimgement Complaint against all mentioned ANDA filer in Jurisdiction District of Delaware 

This is an action for patent infringement arising under the patent laws of the United States, Title 35, United States Code, against all defendants. This action relates to Abbreviated New Drug Application (“ANDA”) No. 208599 (“ticagrelor ANDA”) filed by Defendant with the U.S. Food and Drug Administration (“FDA”) for approval to market generic versions of AstraZeneca’s BRILINTA® (ticagrelor) drug product, prior to expiration of AstraZeneca’s U.S. Patent Nos. 6,251,910 (“the ’910 patent”), 6,525,060 (“the ’060 patent”), 7,250,419 (“the ’419 patent”), 7,265,124 (“the ’124 patent”), and 8,425,934 (“the ’934 patent”) that are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”) for BRILINTA® (collectively “the Orange Book Patents”).

BRILINTA is indicated to reduce the rate of cardiovascular death,myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI). For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.

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