Cardio-diabetics set to gain as key drugs go off patent

Indian cardio-diabetic patients are in for a huge relief as prices of two key diabetes and heart ailment-related drugs have gone off-patent this year and home-grown companies have rushed to fill the market with cheaper generic variants of the innovator drugs. The prices have already dropped by almost 80 percent in most cases.

The good news is that more diabetes drugs are set to go off-patent in the next two to four years, bringing relief to India’s 73-million diabetics. Swiss multinational Novartis’ Galvus (Vildagliptin) went off patent in December. From 20-25 per dose (a patient needs two doses per day), the prices have already fallen in the range of 5 and 6 per dose, or about 10 per day for a chronic diabetic patient. Earlier this month, Ahmedabad’s Eris Lifesciences acquired Zomelis for Vildagliptin-based formulations from Novartis for 93 crores. The market is heating up.

At least 30 new brands are already available in the market, with almost every major pharma company in the country Torrent, Zydus, Intas, Lupin, Panacea, Cipla, Zuventus, Emcure going after this drug. The market size is estimated to be roughly around 900 crore or so (along with its combination with Metformin, another diabetes drug).

Another cardiac drug Ticagrelor (AstraZeneca sells as Brilinta) went off patent this year. And Bristol-Myers Squibb’s Apixaban (brand name Eliquis) is under litigation related to a timeline for patent expiry. One patent expires this month, but the innovator had claimed that another one protects it till September 2022.

Hyderabad’s Natco Pharma has already tried to launch a generic Apixaban (named Apigat) and the matter went to Delhi High Court. “Domestic companies are ready with their generic versions of Apixaban and most would be launching it using the same route as Natco,” said a senior official of a Mumbai-based company planning to launch the product.

Ticagrelor is a platelet aggregation inhibitor or a blood thinner. It is prescribed to patients with a history of cardiac illness to reduce the chances of a heart attack. Apixaban also reduces blood clotting and reduces the chances of a stroke. Ticagrelor was roughly priced around 55 per dose.

The prices are likely to come down to as low as 12, claimed industry insiders, with the average price at ~20 per dose. Similarly, Apixaban prices have come down from ~70 to ~12 per dose. A chronic patient stands to save around 80 percent of his monthly cost on these medicines if he switches to home-grown brands.

“The innovator companies, too, have slashed their prices, but they would still continue to command a premium pricing as they are the innovators. Doctors who prefer to prescribe innovator brands may continue to do so. Even then the patient stands to benefit, saving anything between 40 percent and 50 percent,” said the head of the cardio-diabetic and drug licensing division of a leading pharma company.

Will there be a price war? A senior official of a Mumbai-based drug firm said he does not think so. Another diabetes drug Teneligliptin (Mitsubishi Pharma drug) had seen a major bloodbath in the domestic pharma market after the patent expired.

While Glenmark was the first to launch the generic version in June 2015 for 19.9 per dose, soon at least 100 brands followed, with prices crashing to almost 6-7 per dose. “Gliptins were available for 40-45 a dose prior to Teneligliptin.

When the patent expired, the initial prices fell to a third of the innovator price. Pharma companies thought it was a substantial reduction and the first movers did brisk business.

The later entrants did not have any other strategy, but to have a pricing advantage and the prices continued to fall,” he explained. Teneligliptin was also not backed by good clinical data, which also made pricing the main strategy for companies to push the drug.

But, the case for Vildagliptin is likely to be different it has established efficacies and it is likely to eat into the ~600-crore Teneligliptin market. “Moreover, from specialist doctors, now even general physicians would start prescribing Vildagliptin, thus, expanding the market significantly in terms of volumes,” said drug launching the drug.

Gliptins are a new category of drugs for diabetes treatment with a market size of ~3,500- 4,000 crore, growing at 30 percent or more.

The overall diabetic market is estimated to be around 13,000 crores or so, dominated by a cheap drug Metformin. A Gujarat-based company launching its own Vildagliptin brand said it expected at least 50 brands in the segment, as the market expanded along with further price erosion. Sitagliptin is set for patent expiry next around 2021 along with some drugs in the SGLT2 inhibitor (also called gliflozins) segment in the following years.