Hyderabad: Merck Sharp & Dohme Corp, a subsidiary of Merck & Co has filed a petition in a US court against Aurobindo Pharma Limited alleging the Indian drug maker is planning to come out with generic versions of its blockbuster drug Janumet before expiration of patent. Merck filed the possible patent infringement petition against Aurobindo in the United States District Court for the District of Delaware on four counts last week.
Janumet (metformin hydrochloride and sitagliptin Phosphate) which is indicated to control high blood sugar in people with type 2 diabetes clocked over USD two billion revenues globally including USD 589 million in the USA in 2019, according to Merck’s 2019 annual report.
Patents of Janumet will expire in July 2022 for the USA with six-month pediatric exclusivity, Merck said in the annual report.
Merck in its petition, said that Aurobindo Pharma had submitted ANDAs (abbreviated new drug application)to the US Food and Drug Administration (FDA) seeking approval from the health regulator to engage in the commercial manufacture, sale, and/or importation of the intended generic drugs prior to the expiration of the “708” patent.
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Merck sought the court, among others, apreliminary and permanentinjunction enjoining Aurobindo, and all personsacting in concert with it, from the commercial manufacture, use, sale, offer for sale, orimportation into the United States of the Indian drug maker’s ANDA Products, or any other drug productcovered by or whose use is covered by the “708” patent, prior to the expiration.
In June, Merck dragged Dr Reddy’s Laboratories to a US court over similar patent issues on Janumet and Januvia. Under Paragraph IV Patent Certifications, a company can seek FDA approval to market a generic drug before the expiration of patents related to the branded medicine that the pharma company seeks to copy.
Acity-based pharmaceutical company senior official said patent litigation cases are not uncommon for generic drug makers in the USA and the lawsuit will not have any implications on the performance of the company.