Legal battle on the anvil as Indian companies launch copies of Jardiance

A controversial spin is in the works with MSN Laboratories launching what it terms is the most affordable copies of Jardiance (empagliflozin), the top-selling patented anti-diabetes pills sold by German drugmaker Boehringer Ingelheim (BI) - in India. Earlier, Hyderabad-based Dr Reddy's Laboratories (BSE: 500124) had launched copies of Jardiance.

According to MSN, empagliflozin tablets are sold under the brand name 'Empaone' with the company "aiming to provide affordable and accessible treatment options for diabetics in need across India."

The Hyderabad-based pharmaceutical company said it has developed the active ingredient (API) and final dosage form (FDF) at its state-of-the-art R&D center. "Development is completely unique, from conceptualization to API development and FDF," MSN said in a statement.

Earlier, Dr Reddy’s released a copy of Jardiance. According to experts, the launch could be controversial and could lead to a legal battle. BI may request temporary restraint orders.

The drug has a valid patent in India until 2025, but Indian firms are debuting empagliflozin copies ahead of expected patent expiry for the diabetes blockbuster. Cipla and Lupin also sell empagliflozin under license from BI.

Boehringer response

"There is information about the launch of a generic empagliflozin molecule by a domestic pharmaceutical company. This may be a case of patent infringement. Options (are on) to protect the rights of empagliflozin as an active patentee. We are exploring the exercise of patent rights, which is essential to promote the Indian patent system and patient-centered progress and innovation," according to a Boehringer Ingelheim statement.

There are 77 million people in India who suffer from type 2 diabetes. According to IQVIA data as of August 2021, the Indian anti-diabetes drug market is growing at 9% every year. Among them, SGLT2 inhibitors and their combinations swelled and are the fastest of all other classes of anti-diabetes drugs.