AstraZeneca Moves U.S. Court Against Dr Reddy’s On Brilinta Generic Drug
AstraZeneca Plc has filed a petition in a U.S. court alleging Dr Reddy's Laboratories Ltd. is attempting to come out with the generic version of its patented drug Brilinta (Ticagrelor) in the U.S. before the expiration of a patent of the drug.
In a petition filed in the District Court of New Jersey on July 23, AstraZeneca alleged Dr Reddy’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 U.S.
Brilinta is indicated to reduce the rate of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome 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 U.S. Dr Reddy's submission of Abbreviated New Drug Application 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 U.S. laws, AstraZeneca claimed.
Brilinta clocked $1.32 billion in sales in 2018 worldwide including $588 million in the U.S., according to AstraZeneca. Earlier through a letter, the Indian drugmaker notified AstraZeneca UK Ltd. and AstraZeneca Pharmaceuticals LP that it had submitted its Ticagrelor ANDA to the U.S. FDA.
AstraZeneca also said in its petition that Dr Reddy’s may manufacture, market, and/or sell within the U.S. the generic product described in the Ticagrelor ANDA if the U.S. FDA approval is granted.
In the notice letter, Dr Reddy’s notified AstraZeneca that its Ticagrelor ANDA contained a "Paragraph IV certification" asserting the Patent 276 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 U.S. FDA's approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy.
A Mumbai-based pharmaceutical company senior official said patent infringement cases are not uncommon for generic drugmakers in the U.S. and the lawsuit will not have any implications on the performance of Dr Reddy’s.
On Thursday, Dr Reddy’s shares rose 2.20 percent to Rs 2,655.10 apiece on the BSE while the benchmark Sensex shed 0.04 percent to end the day at 37,830.98 points.