Generics surge as patent expiry restores mkt pulse, boosting drug volumes

Hundreds of generic brands have flooded the market after patents expired for key anti-diabetic and cardiac drugs in the past four to five years. These generic brands have not only enhanced patient access by making the drugs more affordable, but they have also driven up volumes. 

An analysis by Pharmarack, a market research firm, showed that 226 vildagliptin (anti-diabetic) brands are now available in the market after Novartis’ patent expired in December 2019. Similarly, 200 dapagliflozin brands have already been launched in the domestic market since the patent expiry in October 2020. Dapagliflozin was discovered by Bristol Myers Squibb and developed in partnership with AstraZeneca. 

Sheetal Sapale, vice-president (commercial) at Pharmarack, told Business Standard that once a patent expires, several generics are launched, and within a few months, prices crash to one-third — or in some cases, one-fifth — of the originator brand. Volumes also surge at the same time. By the third year after patent expiry, dapagliflozin volumes had increased tenfold. 

This is because as the drugs become more affordable, more doctors begin prescribing them, increasing their reach. 

Rajeev Juneja, managing director of Mankind Pharma, said that after generics are launched, even general physicians will start prescribing empagliflozin (which went off-patent this March), further increasing volumes and patient access. Juneja expects volume growth to be in the range of 50–100 per cent after patent expiry, while the value will decline this year due to the price crash. “In two to three years, the value of the drug will surpass the current market size,” he said. India is home to more than 100 million diabetics, and demand for diabetic drugs is rising — the Rs 20,611 crore anti-diabetic drug market in India is growing at about 9 per cent. The cardiac segment is valued at Rs 29,855 crore and is growing at 10.8 per cent. Together, the cardio and diabetic segments contribute around one-fifth of the domestic pharmaceutical market. 

While hundreds of brands are launched, all vying for market share, many do not survive. “If quality assurance and quality control are strictly followed, these brands work. Otherwise, smaller brands vanish, as doctors are cautious when choosing a branded generic drug,” Sapale said. The ensuing price war, however, benefits patients. 

Empagliflozin prices crashed by 90 per cent — from Rs 60 to Rs 5.5 per tablet — as Mankind Pharma, Glenmark Pharmaceuticals, Alkem, CORONA Remedies, and others launched the drug this week. Many more companies are likely to follow suit. 

Another key class of drugs, GLP-1 receptor agonists (GLP-1 RAs), is set to go off-patent, with Novo Nordisk’s blockbuster drug semaglutide losing patent protection in 2026. Several companies, including Mankind, are in the fray to develop the drug in-house and launch it in the Indian market.