Aurobindo Pharma in legal battle with Merck over blockbuster diabetes drug Janumet
Hyderabad: In a major setback to Aurobindo Pharma, Merck Sharp & Dohme Corp, a subsidiary of Merck & Co has filed a petition in a US court against the Hyderabad-based drugmaker for allegedly planning to come out with generic versions of Merck's blockbuster diabetes drug Janumet before the expiration of the 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 looked over USD two billion revenues globally including USD 589 million in the USA in 2019, according to Merck's 2019 annual report.
Patents of Janumetwill 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.
As per a recent PTI report, 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 IVPatentCertifications, 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.
A city-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.