A blockbuster heart failure drug by Swiss pharma major Novartis is going off-patent in January this year. Several pharmaceutical industry experts told Financial Express.com that the patent loss of Vymada or Entresto is set to cause major disruptions in India’s cardiology sector.
In India, the drug is sold as a combination of Sacubitril and Valsartan and is one of the fastest-growing drugs in the country’s Rs 23,000 crore cardiac market. Reportedly, it has reached a size of Rs 550 crore in the Indian cardiac market and is estimated to have a size of $4 billion globally.
According to WHO, heart failure is a major public health problem in India, with an estimated 2.8 million new cases occurring each year.
With the drug going off-patent, many pharmaceutical companies like Torrent Pharma, Sun Pharma, Cipla, Lupin, USV have already jumped on the chance to market generic versions of the drug.
Vymada, a prescription medication used to treat heart failure, is a combination of two drugs – Sacubitril and Valsartan – and works by inhibiting the enzyme Neprilysin, which breaks down proteins that help relax and widen blood vessels.
According to Dr. P Ashok Kumar, Advanced Heart failure management & Transplant Cardiologist, SPARSH Hospital, Vymada is a “real game changer” in the management of patients with heart failure.
Vymada (sacubitril + valsartan) is a leading drug to treat adults with long-lasting (chronic) heart failure to help reduce the risk of death and hospitalization. The first ingredient, valsartan, has been used for years to treat heart failure.
“Valsartan reduces blood vessel tightening and the build-up of sodium and fluid. The second ingredient, sacubitril, works unlike any other heart failure treatment and can only be found in Vymada. It helps relax blood vessels and decrease sodium and fluid in the body,” Prashant Khadayate, Director – Lifesciences Consulting and Research, GlobalData, told Financial Express.com.
According to GlobalData’s ‘Pharmaceutical Intelligence Center’, the number of diagnosed prevalent cases of heart failure in India is estimated to grow at a CAGR of 4.02%, from 10.2 million in 2022 to 12.5 million in 2028.
Patent Expiry: An Opportunity for Domestic Player
According to Khadayate, Vymada’s patent expiry will provide an opportunity for Indian players to launch a generic version of the drug.
“As a result, we can expect a price reduction for the sacubitril + valsartan combination with the launch of cheaper versions of the same combination in the market following patent expiry. We can expect a price reduction of 55 – 80% from the current Vymada pricing, which is around INR 85 per tablet for Vymada,” he added.
He also emphasised that following this development Indian companies get a chance to strengthen their existing cardiovascular portfolio, which could bring a lot of synergy in terms of more treatment options to both doctors and patients.
In India, Sun pharma has the largest share in the country’s cardiac market, followed by Torrent Pharma, Lupin and USV.
Last year, Dr. Reddy’s Laboratories had already armed its arsenal by acquiring the cardiovascular brand Cidmus from Novartis earlier this year for Rs 463 crore. Currently, each Vymada 100 mg tablet costs around Rs 85.
The development comes after the patent expiry of key anti-diabetes drugs like Sitagliptin. Experts told Financial Express.com that India’s price regulator is keeping an eye on key drugs going off-patent. Reportedly, the Centre and the industry are working on a pricing mechanism for drugs that are going off-patent.
After diabetes, cardiology is one of the fastest-growing therapy areas. Post the patent expiry of the blockbuster drug, major pharma companies are all set for plans to enter the Rs 24,000-crore space to get a slice of the opportunity.
According to experts, there is going to be cut-throat competition in heart failure therapy with over 50 companies launching generic versions of the drug.
“Reduced prices would mean higher prescription and drug adherence resulting in market expansion for the molecule, which presents an opportunity for domestic players to enter with their combination and build their portfolio in the heart failure segment,” Vikas Khare, Vice-President and Chronic Cluster Head, JB Pharma told Financial Express.com.
Dr. Kumar also told Financial Express.com that doctors were using it at a smaller dose rather than titrating it to the highest possible dose.
The drug has a near 40 percent of compound annual growth rate (CAGR). Reportedly, it is one of the fastest-growing molecules in the cardiology segment. The Swiss pharma major markets the drug as Entresto and it has an estimated sales of $4 billion annual sales worldwide.
“Besides Novartis’s Vymada, Dr. Reddy’s, JB Chemicals and Mankind are the other players who are marketing it under their own brands at present but with the patent expiring for the drug, the doors are open for other domestic players to manufacture their own generic counterparts. We expect at least 10 other companies to launch this medicine in this year,” Amit Choudhary, Co-founder and CEO, Dawaa Dost told Financial Express.com.
Moreover, the affordable versions of the blockbuster drug are expected to hit the market this month and reportedly reduce the cost of the therapy by nearly half.
Affordability: A Major Factor
The Swiss firm had launched its brand in India in February 2017 and in-licensed it to Cipla and Lupin.
“Novartis’ Vymada currently sells at ₹1,200 per strip making the medicine unaffordable for the majority of Indians who need it. However, with the drug going off-patent this month, its price is expected to be slashed by 40-50% which will make it affordable for a wider section of the community,” Choudhary
In December last year, JB Pharma cut the price of Azmarda, a cardiac drug patented by Novartis by half. The Rs 500-crore market of sacubitril-valsartan. the combination used in Azmarda, has a CAGR of around 30 percent.
“The benefits of Sacubitril-Valsartan will be extended to more patients as it will become more affordable. Currently, only 20 to 25% of deserving patients have been prescribed this molecule due to its high cost. Patients have to Price reduction after patent expiry will help in improving patient adherence and higher prescription benefitting more patients,” Khare told Financial Express.com.
The doctors told Financial Express.com that they believe 50-60 per cent of patients could be prescribed this drug if it became more affordable.
“In a developing country like India, the cost has always been a factor and the medical care expenses are huge. Most of the medications used in heart failure management are extremely costly, especially in the initial phase until the patency of the molecules go away. If there are 4 to 5 heart failure medications and if all of them are expensive, it becomes difficult for the patient to manage the cost,” Dr. Kumar told Financial Express.com.
According to Dr. Kumar, if the cost drops it will definitely be beneficial for the overall health sector and the other medications also may be brought under the price control regime.
At present, Azmarda is the third largest brand in the category and commanded 17 percent market share with moving annual turnover (MAT) sales of Rs 93.5 crore in October, according to market intelligence agency IQVIA.
In April 2022, JB Pharma acquired the Azmarda brand for Rs 246 crore from Novartis Switzerland for sales in the India region. According to the company, the drug will likely be prescribed twice as much as it becomes affordable.
What More Needs to Be Done In This Segment?
According to Khare, although the patent loss will make Sacubitril-Valsartan more affordable, adding to that Heart Failure Support or Assistance programs should be initiated.
“This will help patients play an active part in the treatment of heart failure by monitoring key measurements, recording the medication they are taking, understanding the disease, and adopting healthy lifestyle changes,” he added.
He also emphasised that awareness of Heart Failure needs to be increased in common people.
“Most people miss the early signs resulting in delayed diagnosis and therapy initiation. Aware people make informed health decisions which will help doctors diagnose more patients at an early stage and save more lives,” he said.
Choudhary emphasised that although we have made progress with respect to making cardiac care more affordable in terms of providing free treatment.
“…to people from economically weaker sections of society at government hospitals or enabling angioplasties at ₹50,000 which is a fraction of the real price of the procedure, we have barely scratched the surface especially when it comes to post-cardiac disease care.”
He said that this will not only help reduce the household expenditure on CVD medicines by 50-80 percent, but also ensure that the patient remains adherent, which is crucial in managing the disease as most CVDs are progressive diseases.