Representative photo: Anastasiia Ostapovych/Unsplash.
The Indian diabetes market is heating up as a new class of diabetes drug that many Indian companies have been eyeing, but held back on because of patents, is finally seeing action. The Ahmedabad-based pharmaceutical giant Zydus Healthcare announced on October 4 that it is launching tablets of Dapagliflozin in India “upon its patent expiry under the brand name Dapaglyn”. AstraZeneca innovated this drug, and has licensed its sales in India by Sun Pharma and Abbott Healthcare.
Zydus has said Dapagliflozin will be available at a third of the price. This translates to Rs 17 for a 10-mg pill and Rs 14 for a 5-mg pill. A day later, Eris Lifesciences, another Ahmedabad-based company, also launched the drug with its own 10-mg variant priced at Rs 14.50 a tablet, and a 5-mg tablet for Rs 14. Other companies are also in the process of launching their Dapagliflozin variants, with some even attempting to price each pill at Rs 12 or lower.
At the same time, at least 10 companies, including Zydus, Natco, Ajanta and Intas, are involved in a patent infringement case currently in court. There is already an injunction order against Natco to stop selling the product in the market; two other companies have been restrained; court hearings are on for other companies while even others haven’t been listed yet.
An AstraZeneca Pharma India spokesperson reserved comment on the matter since it “is sub judice and being actively heard in the court”. However, he still said that “AstraZeneca has a strong patent portfolio for novel compound Dapagliflozin” and that it has “filed many lawsuits against generic companies that have launched or are about to launch their generic versions of Dapagliflozin” without AstraZeneca’s authorisation.
Zydus Healthcare has claimed that the product was launched immediately after its patent expired in India. Manufacturers of generic drugs have contended in turn that Zydus’s decision amounts to patent evergreening. ‘Evergreening’ loosely refers to attempts by innovators to extend their intellectual property rights over a product.
“Emerging markets like India have stricter patent laws against evergreening of patents,” Aditya Khemka, a veteran pharma analyst, said. So “such patent cover is either denied or defeated in the court of law, thereby enabling generic companies to launch generic versions of a medicine.”
Then again, there is also the significance of Dapagliflozin to consider. Dapagliflozin is part of a newer class of medications called sodium-glucose co-transporter 2 (SGLT-2) inhibitors. According to Khemka, the market for these drugs is “growing at 20% per annum in India”. So Khemka argues that it is inevitable that “new players will enter the space” and “prices will come down”. And if multiple companies launch generic versions of Dapagliflozin at the same time, “it will really bring down the prices – but if the entry of new players is staggered over a period of time, then there will still be a lower-intensity price war.”
Dapagliflozin is targeted principally at patients of type 2 diabetes. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine, and checks the progress of renal failure. On July 4 this year, AstraZeneca India received marketing authorisation for Dapagliflozin, sold under the brand name Forxiga, to treat patients with heart failure with reduced ejection fraction (HFrEF)[footnote]When the left side of the heart doesn’t pump blood out normally[/footnote]. As a result, according to AstraZeneca, it became “the first in class SGLT-2 inhibitor drug approved [to treat] HFrEF”. And according to a Zydus spokesperson, the ingredients required to make Dapagliflozin tablets don’t have to be imported.
The challenge at the moment is that the drug apparently has two patent registrations in India — IN 205147, which is the ‘genus patent’ up to October 2, 2020, and IN 235625, the ‘species patent’ valid up to May 15, 2023. Since April this year, AstraZeneca has taken several companies to the Delhi high court alleging patent infringement, and hearings are underway.
But given the drug’s benefits and its market potential, Khemka’s prediction — that there will be competition and a price war — is expected to hold out. “This looks like a repeat of what had happened when the Novartis diabetes drug Vildagliptin went off-patent in December 2019,” Hari Natarajan, founder and managing director of Pronto Consult, an independent consulting company specialising in doctor perception studies and market insights, said. “It had seen multiple players enter the Indian market, and the price of the drug fell from Rs 45 per tablet to as low as Rs 5 per tablet. Now, again, we are likely to see this with Dapagliflozin.”
“Zydus has already launched it
According to AIOCD AWACS, the market for anti-diabetes medicines is a huge and growing market. It today stands at around Rs 14,000 crore (in terms of retail sales of anti-diabetes medicines in India in a year) and is growing at around 8% per annum. Within this, the market for dapagliflozin alone is today at around Rs 360 crore (this includes dapagliflozin tablets and tabl
In March 2016, Sun Pharmaceutical and AstraZeneca India announced a partnership to distribute Dapagliflozin. Sun Pharma has been promoting and distributing this drug under the brand name Oxra. AstraZeneca has also entered into a licensing agreement with Abbott Healthcare.