India’s pharmaceutical landscape is set for a major shake-up as domestic drugmakers gear up to launch affordable versions of the diabetes drug Empagliflozin. With Boehringer Ingelheim’s patent expiring on March 11, companies like Mankind Pharma, Torrent, Alkem, Dr Reddy’s, and Lupin are preparing to introduce low-cost alternatives—bringing relief to millions of diabetes patients.

The Indian pharmaceutical industry is on the brink of a breakthrough in diabetes treatment, with leading domestic drugmakers preparing to introduce cost-effective generic versions of the blockbuster diabetes drug, Empagliflozin. According to a Times of India report, following the expiration of Boehringer Ingelheim’s patent on March 11, companies like Mankind Pharma, Torrent Pharmaceuticals, Alkem Laboratories, Dr Reddy’s, and Lupin are set to offer this life-saving medication at a staggering 90 per cent lower price. This move will significantly reduce the financial burden on millions of diabetes patients in India, making advanced therapy more accessible than ever before.

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Following the expiration of Boehringer Ingelheim’s patent on March 11, companies like Mankind Pharma, Torrent Pharmaceuticals, Alkem Laboratories, Dr Reddy’s, and Lupin are set to offer this life-saving medication at a staggering 90 per cent lower price.

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Massive Price Drop to Benefit Millions

Empagliflozin, an SGLT2 inhibitor, is widely prescribed for managing type-2 diabetes and reducing risks of heart failure and chronic kidney disease. The drug has been effective in improving cardiovascular outcomes and slowing disease progression. However, its high cost has remained a significant barrier for patients.

Currently, the innovator’s version costs around Rs 60 per tablet, but the upcoming generics are expected to be priced between Rs 9 and Rs 14 per tablet. This marks a game-changing shift in the diabetes drug market, which has expanded from Rs 14,000 crore in 2021 to nearly Rs 20,000 crore today.

Why This Matters: India’s Diabetes Crisis

India is home to an estimated 10.1 crore (101 million) diabetes patients, making it one of the largest diabetic populations in the world. According to the International Diabetes Federation (IDF), most patients in India bear out-of-pocket expenses due to limited medical reimbursement policies. The rising cost of diabetes management, coupled with complications such as heart disease, kidney failure, and nerve damage, underscores the urgent need for affordable treatment options.

Pharma Giants Gearing Up for Market Domination

Among the frontrunners in this space is Mankind Pharma, India’s fourth-largest pharmaceutical company by market share. The company has announced plans to launch Empagliflozin at one-tenth of its current price. Meanwhile, Torrent Pharmaceuticals strengthened its position by acquiring three Empagliflozin brands from Boehringer Ingelheim last year, ensuring a strong foothold in this rapidly expanding segment.

A Mankind Pharma executive as reported by The Economic Times emphasized the company’s commitment to affordability:

“This aligns with our philosophy of breaking cost barriers with a high-quality product (raw materials certified by regulators like the US FDA) at an affordable price. Using our active pharmaceutical ingredient (API) in bulk lowers costs, and we will deploy separate teams to promote two distinct brands, boosting distribution and market share.”

Implications for the Broader Diabetes Drug Market

The introduction of low-cost Empagliflozin generics is likely to have far-reaching effects on the diabetes drug market in India:

Market Dynamics: The availability of affordable Empagliflozin is expected to intensify competition among pharmaceutical companies, potentially leading to price reductions in other diabetes medications as firms strive to maintain their market share.

Market Share of Similar Drugs: Drugs such as Dapagliflozin, another SGLT2 inhibitor, currently hold a significant portion of the market. The entry of cheaper Empagliflozin generics could challenge this dominance, prompting a reevaluation of pricing and marketing strategies among competitors.

Empagliflozin: A Distinctive Therapeutic Option

Empagliflozin differentiates itself from other diabetes medications through its unique mechanism of action and additional health benefits:

Mechanism of Action: As an SGLT2 inhibitor, Empagliflozin works by blocking the reabsorption of glucose in the kidneys, leading to its excretion through urine. This insulin-independent pathway offers an alternative for patients who may not respond well to other treatments.

Cardiovascular and Renal Benefits: Beyond glycemic control, Empagliflozin has demonstrated efficacy in reducing hospitalisations related to heart failure and in slowing the progression of chronic kidney disease, benefiting both diabetic and non-diabetic patients.

Potential Impact on Diabetes Management

The availability of affordable Empagliflozin generics could revolutionise diabetes management in India:

Enhanced Accessibility: Lower prices are expected to make advanced diabetes treatments accessible to a broader patient population, particularly those in middle- and lower-income groups who previously found the costs prohibitive.

Shift in Treatment Paradigms: Healthcare providers may consider prescribing Empagliflozin earlier in the treatment regimen, given its comprehensive benefits and improved affordability.

Development of Combination Therapies: The introduction of cost-effective generics may encourage the development of new combination therapies, potentially enhancing treatment efficacy and patient adherence.

“The availability of generics will give patients more choices, but the impact may not be as significant as when Dapagliflozin went off-patent,” said Sheetal Sapale, Vice President (Commercial) at Pharmarack (as reported by The Indian Express).

With this move, India’s Empagliflozin market, currently valued at ₹640 crore, is expected to see an unprecedented surge in competition. Pharmaceutical firms are racing to capture a larger share, intensifying price wars and ultimately benefiting millions of Indian patients.

While Metformin remains the first-line treatment for type-2 diabetes, the inclusion of SGLT2 inhibitors like Empagliflozin in combination therapies has proven beneficial for glycemic control and cardiovascular health. The arrival of affordable generics will revolutionize the diabetes treatment landscape, paving the way for a healthier, more accessible future for millions.