In India, the entry of cheaper generic versions of two widely-used diabetes medicines, Jardiance (empagliflozin) and Tradjenta (linagliptin) has been temporarily blocked, according to The Times of India (TOI).
In March, the Himachal Pradesh high court passed separate orders on German firm Boehringer Ingelheim’s plea, restraining Dr. Reddy’s and Macleods from producing and marketing these two diabetes medicines.
The U.S. Food and Drug Administration (FDA) approved Jardiance in August 2014 and Tradjenta in May 2011 – both drugs are manufactured by Boehringer Ingelheim.
The generic versions of these drugs, launched by Indian companies, are marketed at a fraction of the price, reducing treatment costs for patients with diabetes.
Several Indian companies have launched generic versions of Jardiance and Tradjenta. The patent on these brand-name drugs is about to expire. Boehringer Ingelheim holds the patent for Jardiance and Tradjenta in India until 2025 and 2023, respectively.
In a recent suit filed by Boehringer Ingelheim against Macleods on Tradjenta, Justice Ajay Mohan Goel said, “This order is being passed taking into consideration the un-rebutted facts, at least till this stage, that there exists an Indian Patent 243301 in favor of the applicants, which is to expire on 18th August, 2023 and the respondent, without any valid patent or authorization/license from the applicant, has started manufacturing and selling the infringing product under the brand name of Linamac and Linaone.”
A Boehringer Ingelheim spokesperson told TOI that the company has obtained “separate court orders, granting a permanent injunction and an ad-interim injunction restraining domestic pharmaceutical manufacturing companies from manufacturing and selling generic versions of empagliflozin and linagliptin drugs in the country.”
“The high court has pronounced its decision dismissing the requests made by MSN Laboratories and Dr. Reddy’s – both domestic pharmaceutical manufacturers – to vacate the ad interim injunctions restraining them from manufacturing and selling generic versions of empagliflozin drugs.” the spokesperson added. “Consequently, the ad-interim injunction granted against MSN Laboratories and Dr. Reddy’s in October 2021 has been made absolute by the High Court.”