MSN Labs launches patented diabetes pill Jardiance after DRL, heats up potential legal battle

Hyderabad-based drugmaker MSN Laboratories on Monday said it has launched the most affordable copies of Jardiance (Empagliflozin), the top-selling patented anti-diabetes pills sold by German drug maker Boehringer Ingelheim (BI).
MSN said its Empagliflozin tablets to be sold under brand name ‘EMPAONE’ will cost Rs 15.90 and Rs 18.90 for each 10 mg and 25 mg tablet respectively, while Jardiance 10 mg and 25 mg prices costs Rs.51.3 and Rs 62.2 per pill.

"‘EMPAONE’ is intended to provide diabetes patients in need across India with an affordable and accessible therapeutic option," MSN said in a release.

The Hyderabad-based drug maker said it has developed the active pharmaceutical ingredient (API) and the finished dosage formulation (FDF) of EMPAONE at its in-house state-of-the-art R&D center.

"The development is fully indigenous right from conceptualization to API development and FDF," MSN said.

ET on Monday reported that Hyderabad-based Dr Reddy's Labs has launched copies of Jardiance, which has valid patent in India until 2025 and experts say the launch is likely to take a controversial spin and head for a court battle. BI may seek temporary restraining order and claim.

Cipla and Lupin also market the Empagliflozin under license from BI.

"We have information about a generic empagliflozin molecule launch by a domestic pharma manufacturer, which could be an instance of patent infringement. We are exploring options to protect our rights as the active patent holder of empagliflozin. We have faith in the Indian Patent system and the enforcement of patent rights, which is imperative to drive patient-centred progress and innovation," BI said.

India has 77 million people suffering from Type 2 diabetes. According to IQVIA data as of Aug. 2021, India's anti-diabetes drugs market was at Rs. 16306 crore, growing annually at 9%. Of that, SGLT2 plain and combinations swelled to Rs. 969 crore and 487 crore respectively, which is the fastest among all other class of anti-diabetes drugs.