Merck files petition in US court against Aurobindo Pharma for Janumet

Merck Sharp & Dohme Corp, a subsidiary of Merck & Co has filed a petition in the United States District Court for the District of Delaware on four counts against Aurobindo Pharma alleging that the Indian pharma company is planning to come out with generic versions of its blockbuster drug Janumet before the expiration of a patent.

Janumet (metformin hydrochloride and sitagliptin phosphate) which is indicated to control high blood sugar in people with type 2 diabetes clocked over $2 billion revenues globally including $589 million in the US in 2019, according to Merck’s 2019 annual report.

Patents of Janumet will expire in July 2022 for the US with six-month paediatric exclusivity, Merck said in the annual report.

Merck, in its petition, said that Aurobindo Pharma had submitted abbreviated new drug application (ANDAs) 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.

Merck sought the court, among others, a preliminary and permanent injunction enjoining Aurobindo, and all persons acting in concert with it, from the commercial manufacture, use, sale, offer for sale, or importation into the United States of the Indian drug maker’s ANDA Products, or any other drug product covered 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.