Dapagliflozin

New Delhi: In less than two months after diabetes drug Empagliflozin went off patent, Indian branded generic players have crowded the market with their versions of the product leading to a month-on-month doubling in the number of players and brands flooding the market in April. Nearly 147 brands of the drug and 37 companies are in the market now, up from 86 brands and 19 companies in March, according to data from industry tracker and market researcher PharmaTrac. Doctors said that an increasing number of anti-diabetic drugs going off patent-with Empagliflozin being the latest-is good for patients and medical practitioners as it makes anti diabetes drugs more affordable in India where cases of diabetes are rising. Empagliflozin-which was Boehringer Ingelheim's innovator drug sold under the brand name Jardiance-went off patent mid-March. It is used to improve glucose control in people with Type 2 diabetes. "With almost 150 brands and 40 companies jumping in the Empagliflozin off patent opportunity and volume sales picking up steeply in the last two months, every player in the IPM (Indian pharmaceutical market) looks like geared up to make the most of this opportunity," said Sheetal Sapale, vice president, commercial, PharmaTrac. "Most of the innovator molecules (used to treat Type 2 diabetes) in SGLT 2 (Sodium-Glucose Co-Transporter-2) and DPP4 i (Dipeptidyl peptidase-4 inhibitors) have gone off patent... creating many affordable options available to eligible Indian masses through branded generics ," she added. Empagliflozin is an SGLT-2 inhibitor . Others in the same group include dapagliflozin-whose patent expired a couple years ago leading to nearly 200 generic brands coming into the market. Companies such as Alkem Laboratories , Glenmark Pharmaceuticals and Mankind Pharma launched their versions of Empagliflozin, and slashed prices to about ₹5 per unit, which is 80-90 per cent lower than the innovator's prices. "Ever since dapagliflozin has gone off patent, many more people have access to it has become cheaper. Empagliflozin is also similar to it...it's a good medicine for sugar, gives some protection to the heart and kidney too," said Dr David Chandy, director-endocrinology & diabetology at Sir H N Reliance Foundation Hospital and Research Centre. More such molecules going off patent increases the reach to larger populations. "Earlier when only the innovators had these molecules, maybe 2-5 per cent of India's diabetic population could afford it, now the entire diabetic population can afford it," said Chandy. Empagliflozin is a ₹745 crore market today with plains contributing to almost 45 per cent in terms of value as well as quantity. Empagliflozin plain and Empagliflozin plus Linagliptin contribute nearly 80 per cent of this. "In the long-term, more and more affordable medication options are good for patients with the cases of diabetes spiralling in the country and doctors have more ammunition or options for treatment now compared to 5-10 years back," said Chandy. "What will be interesting in the diabetes scenario is that in the next six months, once semaglutide goes off patent, there will be a paradigm shift for diabetes treatment once it is available at a low price," he said. By Rica Bhattacharyya ,

AstraZeneca's bid to derail Medicare's power to negotiate lower drug prices on certain prescription drugs under the Inflation Reduction Act (IRA) has failed in a US appeals court.In a ruling Thursday, the Third Circuit Court of Appeals sided with the US government, affirming a lower court's 2024 dismissal of AstraZeneca's lawsuit. That court found AstraZeneca hasn't shown it was directly harmed by the negotiation programme and failed to prove the law violated its constitutional rights.AstraZeneca filed its lawsuit against the US government after the Centers for Medicare & Medicaid Services (CMS) selected its drug Farxiga (dapagliflozin) almost two years ago as one of the first 10 medicines subject to price negotiations under the IRA. The discounted prices are set to take effect at the start of 2026.The company claims that the negotiation programme deprives it of procedural due process and that some provisions of CMS guidance regarding how it selects qualifying drugs violate the Administrative Procedure Act (APA).Regarding the alleged APA violations, AstraZeneca said the price negotiations would impact its ability to make R&D decisions. However, the court found the company's evidence lacking, noting that its only support was an executive's affidavit citing potential effects on research investments — an assertion the panel concluded "does not establish a concrete and particularised injury to AstraZeneca."AstraZeneca's claim that the programme hindered its ability to value Farxiga during negotiations with CMS was also tossed.Meanwhile, AstraZeneca's due process challenge was dismissed as well. The company said the IRA's price negotiation scheme limits its ability to sell its drugs at a market rate, infringing on its property rights. However, the appeals court rejected that argument, saying "there is no protected property interest in selling goods to Medicare beneficiaries… at a price higher than what the government is willing to pay when it reimburses those costs."AstraZeneca also argued that the programme is unfair because it lets the government impose price controls without allowing companies to challenge those decisions in court. The appeals court disagreed, finding "these are not private market transactions, regardless of the private hands through which CMS's funds pass."Mulling next stepsIn an emailed statement to FirstWord, a company spokesperson said "AstraZeneca is disappointed by the Court's decision and is considering next steps."A number of drugmakers have tried to challenge the Medicare drug negotiations, including Johnson & Johnson, Merck & Co., Bristol Myers Squibb and Boehringer Ingelheim, most ending in failure. However, late last year, the Fifth Circuit Court of Appeals handed industry a narrow victory by reversing an earlier dismissal and allowing PhRMA and other groups to challenge the drug negotiation programme.Earlier this year, 15 drug products were chosen for the second round of US drug price negotiations.