Pharma companies are launching generics of Sitagliptin post-patent expiry; Can this make diabetic care affordable? – The Financial Express

Sitagliptin, an anti-diabetic drug, sold under the brand name Januvia and is used to treat Type 2 diabetes. In July this year, the drug lost its patent. Usually, loss of patent means a fall in the price of the drug, and according to industry experts, sometimes by more than 50-70 per cent.
Interestingly, several pharmaceutical companies have already launched generic versions of the anti-diabetic drug.
Experts told Financial Express.com that the patent loss can be a huge relief for patients with type-2 diabetes in India as it is expected to massively reduce the cost of the drug.
According to 2019 estimates, 77 million individuals had diabetes in India, which is expected to rise to over 134 million by 2045. Diabetes was the ninth leading cause of death with an estimated 1.5 million deaths directly caused by the disease in India.
“Sitagliptin, was a ‘wonder drug’ for type 2 Diabetes launched in 2006 by Merck. Sitagliptin, sold under the brand name Januvia, is the drug of choice used to treat high blood sugar levels caused by type-2 diabetes. Sitagliptin works by increasing levels of natural substances called incretins which help to control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar the patient’s liver makes,” Amit Choudhary, Co-founder and CEO, Dawaa Dost told Financial Express.com.
According to Choudhary, Sitagliptin has been shown to lower HbA1c levels by about 0.7% points versus placebo.
Sitagliptin is one of the most effective drugs used in diabetes management as substantiated by data collected and analysed over several years. Sitagliptin does not have any major side effects and is, therefore, an important drug in diabetes management, he added.
Sitagliptin is a drug used in patients with type-2 diabetes mellitus- a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces.
“Sitagliptin is a class DPP-4 Inhibitor and a blockbuster drug proven to have good results in diabetes control the world over. It is important because out of the 7 odd gliptins which were introduced Sitagliptin was amongst the top performing drugs,” Ankur Agarwal, Founder, Medkart told Financial Express.com.
Hyperglycaemia, or when the body cannot effectively use the insulin it produces. Hyperglycaemia, or high blood sugar, is a common effect of uncontrolled diabetes and over time causes serious damage to many of the body’s systems.
Earlier this year, India’s drug price regulator National Pharmaceutical Pricing Authority (NPPA) fixed the prices of fixed-dose combinations of several anti-diabetic drugs. Meanwhile, generics Sitagliptin is available in the Indian market with the expiry of the patent.
“With Sitagliptin going out of patent, many pharmaceutical companies like Cadilla, Zydus, have launched generic versions of the drug. This has resulted in a price correction of a critical medicine &  led to the price of Sitagliptin, which was being sold at the rate of ₹45 per tablet to fall to ₹8 – ₹18 per tablet. Sitagliptin becoming more affordable by 50-80% will benefit the 70 mn type-2 diabetics in India (International Diabetes Federation report, 2021), most of whom were unable to afford this medicine,” Choudhary told Financial Express.com.
According to reports, as the patient pool remains limited, the competition in the Oral Anti-Diabetic Drug (OAD) market has intensified. India has a population of 1.4 billion which is growing by less than one per cent every year.
“The pre-patent expiry price of the drug was Rs. 50 per tab and has come down to Rs. 7.7 per tab. A lot more patients who were unable to afford the treatment due to overall cost can now afford it and have better control over their conditions,” Agarwal told Financial Express.com.
However, according to data from market research firm AWACS, US pharmaceutical major Merck, along with its partners, has managed to retain an 81 per cent market share in value terms for its anti-diabetic molecule sitagliptin in the Indian market.
Moreover, New launch activity by generic players, too, has slowed, the data showed. In November, there was no generic brand launch in sitagliptin or the sitagliptin-metformin combination.
The innovator brand from Merck was priced at around Rs 40 per tablet. Glenmark was the first to launch a generic version of sitagliptin, priced at Rs 10-20 per tablet.
According to industry experts, after a patent expiry, the volume of the market expands significantly. There is an interesting trend that is often witnessed in the chronic disease management market.
Patients who suffer from chronic diseases like diabetes often don’t change brands. Consequently, even if the patent goes off, the innovator brand also reduces prices and still maintains premium over generic brands.
“Pharma companies saw an opening with Sitagliptin going off patent in July 2022. On October 6, 2022, Alkem Labs, the country’s 5th largest drugmaker launched for the first time in India, a triple-drug fixed-dose combination (FDC) of dapagliflozin, sitagliptin and metformin under the brand name of Dapanorm trio at an affordable price for adults with type 2 diabetes. On the same day, Glenmark, the country’s top generic drugmaker, launched Lobeglitazone (Lobeglitazone),” Choudhary told Financial Express.com.
According to the International Diabetes Federation, India recorded an estimated 77 million diabetes cases in 2019, of which only around 45 percent were diagnosed. By 2030, this number could touch 100 million.
“With the number of patients increasing, the diabetes care market in India is expected to reach about $60 billion in the next 10 years, from approximately $17 billion, according to Redcore. And every pharma company wants a piece of the pie. This price correction is good news for patients as the price of Sitagliptin saw a 50-80% drop from ₹45 per tablet to fall to ₹8 – ₹18 per tablet making the medicine more affordable to millions of Indians,” he added.
Though there may be several generic launches, only a few 10-15 brands manage to grab a significant share of the doctor’s pen.
“Upon the expiry of a blockbuster drug the rush is seen in almost every big category, Diabetes is a huge category in India and no drug company can ignore it. We at Medkart have seen 8-10x growth in volumes of a drug going off-patent within 12 months of patent expiry. More companies promoting it to more doctors and affordability driving adoption goes hand in hand. A win-win situation for both the patient as well as the doctor,” Agarwal told Financial Express.com.
In September this year, the central government launched diabetes drug Sitagliptin and its combinations at rates as low as ₹60 per pack of ten, which will be sold at generic pharmacy stores, Janaushadhi Kendras.The Ministry of Chemicals and Fertilisers in a statement informed that the Pharmaceuticals & Medical Devices Bureau of India (PMBI) has included new variants of Sitagliptin and its combination across its Jan Aushdhi Kendras.
“India is a 95% + generic medicine market. Hence, any medicine which goes off-patent helps in making the medicine more affordable & accessible to millions of Indians. However, the non-transparent supply chain does not pass on the benefit to the consumer & the consumer is left with paying exorbitant prices for generic medicine. This triggers an avalanche of healthcare issues of trust, adherence and awareness resulting in India being in the bottom quartile of the healthcare benchmarks,” Choudhary told Financial Express.com.
Choudhary also informed that in a country where 85 percent of total health expenditure is out-of-pocket and medicines constitute 20-60 percent of total healthcare expenditure, generics play a crucial role in breaking this vicious cycle and making healthcare affordable for patients.
The Sitagliptin market will also undergo the same market clutter phenomenon as Vildagliptin and Dapagliflozin. Sitagliptin’s impact to be seen in the market may take a few more months of observation.
“Having generic options has nothing to do with quality and more generic options will only come for drugs with wider acceptance. Hence, linking both of them is completely wrong. Wider adoption will drive prices down and the patient should be benefited,” Agarwal told Financial Express.com.
India’s oral anti-diabetic market is worth Rs 12,500 crore, of which DPP4i (Dipeptidyl peptidase 4 inhibitor) class of anti-diabetics has a share of more than Rs 4,000 crore. Sitagliptin is the gold standard in the DPP4i category with over 62 percent market share in the global market.
“Since generic medicines are made exactly the same as an already marketed brand-name drug in every way – dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use – they pose no quality concerns. There have been in the past smaller brands which have made quality & efficacy sacrifices to the detriment of the customer, but broadly, given the strict Government guidelines on manufacturing, there should be no concerns to the doctors,” Choudhary told Financial Express.com.
Ahmedabad-based Cadila Pharmaceuticals has also made a foray into the diabetes care segment with the launch of Sitenali and Jankey, having cardio-safe gliptin sitagliptin.
Last week, Glenmark Pharmaceuticals Limited announced that it has launched the first triple fixed-dose combination Teneligliptin with Pioglitazone and Metformin in India.
In the beginning of this year, Novo Nordisk India launched the world’s first and only “peptide in a pill”, oral semaglutide, a game changer in diabetes management. Semaglutide, a GLP-1 receptor analogue (GLP-1 RA) – one of the drug classes to treat diabetes, till now was available only in the form of injections. This is the first time a GLP-1 RA has been developed in an oral formulation.
According to Choudhary, there is an epidemiology of type 2 diabetes in India with some studies indicating that 57 percent of adults in India are undiagnosed, which is nearly 44 million more patients.
“Given the progressive nature of the disease, the approach to solving and managing this has to be urgent & different from the way of treating an acute patient. We believe a comprehensive cycle of patient management with availability, affordability, education on the medicine and disease in regional languages and check on adherence to the prescription can allow the disease to be ‘managed’ and the progression can be slowed down,” he added.  
All classes of antidiabetic drugs are well represented in India – namely biguanides (metformin), thiazolidones (various glitazones), sulfonyl ureas (glipizide, glimepride), meglitinides (sulfonyl urea analogues such as repaglinide, nateglinide), GLP-1 receptor agonists (incretin mimetics such as liraglutide), DPP-4 inhibitors (gliptins such as sitagliptin & vildagliptin), SGLT2 inhibitors (dapagliflozin, etc.), Alpha glucosidase inhibitors (Acarbose).
However, several industry experts have emphasised that there is a need for new drug development for the treatment of type 2 diabetes and the development of better alternative dosage forms and novel delivery systems to the current injectable insulin for type 1 diabetes. 
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