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BioSpectrum India May 2025

The Indian pharmaceutical market is witnessing a dramatic transformation following the patent expiry of Empagliflozin (sold under the brand name Jardiance by Boehringer Ingelheim) on March 11, 2025, used for treatment of adults with type 2 diabetes mellitus, as an adjunct to diet and exercise to improve glycemic control and to reduce the risk of cardiovascular death in patients with established cardiovascular disease.

Mushrooming Generics.Turn Affordable Lifeline

Jardiance (empagliflozin), a sodium-dependent glucose co-transporter 2 (SGLT2) inhibitor, was approved in 2014 for type 2 diabetes and later expanded to include heart failure and kidney disease indications. In 2023, the drug generated $8 billion in global sales, according to reports. The drug remains the leader in the SGLT2 inhibitor market, holding a substantial 31.2 per cent market share in 2025.

Following the patent expiry of Empagliflozin, multiple branded generics have flooded the Indian market in a short span, signaling one of the most competitive post-patent scenarios in recent years. For instance, on March 12, Alkem Laboratories announced the launch of Empanorm in India, a generic version of empagliflozin, for the treatment of type-2 diabetes mellitus, chronic kidney disease (CKD), and chronic heart failure (HF). The product is priced approximately 80 per cent lower than the innovator drugs, making it more accessible to patients.

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