: Pharma major AstraZeneca has filed a petition in a USA court alleging Dr Reddy's Laboratories Limited is attempting to come out with generic version of its patented blockbuster drugBrilinta (Ticagrelor) in the US market before the expiration of a patent of the drug (276).
In a petition filed in the District Court of New Jersey on July 23, AstraZeneca alleged the Indian drug maker's proposed generic Brilinta will infringe the patent and requested the court to pass an injunction order against manufacturing, importing and selling that drug in the US.
Brilinta is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI) and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction.
AstraZeneca requested the court to pass an order restraining Dr Reddy's from making, selling and also importing the drug into the United States.
Dr Reddy's submission of Abbreviated New Drug Application (A NDA) to obtain approval to engage in the commercial manufacture, use, offer to sell, or sale of generic Ticagrelor tablets prior to the expiration of the patent (276) constituted an act of infringement under US laws, AstraZeneca alleged.
Brilinta clocked USD 1.32 billion in sales in 2018 worldwide including USD 588 million in the USA, according to AstraZeneca.
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Earlier through a letter, the Indian drug maker notified AstraZeneca UK Limited and AstraZeneca Pharmaceuticals LP that it had submitted its Ticagrelor ANDA to the US FDA.
AstraZeneca also said in its petition that DRL may manufacture, market, and/or sell within the United States the generic product described in the Ticagrelor ANDA if FDA approval is granted.
In the Notice Letter, DRL notified AstraZeneca that its Ticagrelor ANDA contained a "Paragraph IV certification" asserting the '276 patent is invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale of its generic version.
Under Paragraph IV Patent Certifications, a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy.
A city-based pharmaceutical company senior official said patent infringement cases are not uncommon for generic drug makers in USA and the law suit will not have any implications on the performance of the company.