Merck files petition against Aurobindo Pharma on “Janumet” – Diabetic Drug
A complaint has been filed in a U.S. court against Aurobindo Pharma Limited by a subsidiary of Merck & Co – Merck Sharp & Dohme Corp, alleging that the Indian drugmaker is preparing to manufacture the generic versions of its drug Janumet before the patent’s expiry. In the United States District Court for the District of Delaware, Merck filed the possible patent infringement petition on 4 counts against Aurobindo Pharma.
According to Merck’s 2019 annual report, the drug – Janumet (metformin hydrochloride and sitagliptin Phosphate) used to regulate high blood sugar in patients with type 2 diabetes clocked over USD 2 billion revenues around the world including USD 589 million in the USA last year.
In the annual report, Merck said that with 6-month pediatric exclusivity Janumet’s patents will expire in July 2022 for the USA.
The petition stated that, so as to participate in the commercial manufacture, sale, and/or importation of the intended generic medicine, Aurobindo Pharma had submitted ANDAs (abbreviated new drug application) to the US FDA seeking authorization before the “708” patent expires. The firm sought the court, among others, a preliminary and permanent injunction urgingAurobindo, and all persons acting jointly with it, from the commercial manufacturer, use, sale, offer for sale, or importation into the United States of the Indian drug manufacturer’s ANDA Products, or any other medicinal product covered by or whose use is covered by the “708” patent, before the expiry of the patent.
Over a similar patent issue on Janumet and Januvia, Merck dragged Dr. Reddy’s Laboratories to a US court in June. A company can seek FDA approval to market a generic medicine prior to the expiration of patents related to the branded medicine that the pharma company looks for to copy, according to paragraph IV Patent Certifications.
The patent lawsuits cases are not rare for generic medicine manufacturers in the US, and the lawsuit will certainly not have any implications on the company’s performance, as per a senior official of the pharmaceutical firm.
Author: Sruthi S