Indian firms rush to tap into US Viagra market
PHARMACEUTICAL GIANT PFIZER WOULD LOSE THE PATENT IN US IN 2020 ON THE BLUE PILL USED FOR TREATING IMPOTENCE
Indian companies are coming up with their Viagra versions to tap into a lucrative American market as pharmaceutical giant Pfizer would lose the patent in the US in 2020 on the blue pill used for treating impotence. Nearly five crore Americans suffer from erectile dysfunction. They will be India’s largest market for exports of medicines.
Seven Indian companies – Rubicon Research, Hetero Drugs, Macleods Pharma, Dr. Reddy’s, Aurobindo Pharma, Torrent Pharmaceuticals and Ajanta Pharma – have got US Food and Drug Administration (FDA)’s approval to produce the medicine. They are among 15 global firms to get the go-ahead for producing sildenafil citrate, the formulation patented as Viagra.
COULD SPARK PRICE CRASH IN THE US
The Indian firms are working on strategies that could bring down the Viagra price in the US by almost 99%. The pill costs about $65 (over ~4,400) in the US. Pfizer had launched its generic version at half the price in 2017.
Experts believe even this would not match the price the Indian firms could offer.
Macleods Pharmaceuticals sells its Viagra version in India for ~58 and Ajanta Pharma for ~32 per tablet.
Pfizer’s global sales from Viagra touched $1.685 billion (over ~10,900 crore) in 2014 while the global erectile dysfunction drugs market was estimated to be worth $4.35 billion in 2016.
Macleods Pharmaceuticals vice president Niteesh Srivastava called lower pricing the only way to gain preference. “Hence, a price war is certain.” Srivastava said lesser-known or relatively smaller firms will be able to crash prices due to less overhead expenditures. He added pharma giants will have a better hold on the pharmacy benefit managers (PBMs) in the US to reach the desired negotiations.
“It is an opportunity for Indian drug makers to cash in on their R&D and pricing strength and get into the US market for Viagra, which has largely been cartel led so far due to patent and policy regulation,” said Sougat Chatterjee, president of TFPL, a global research consulting firm.
The Indian firms face rising FDA license fees. The FDA has increased the fee for processing drug applications by over ~65 lakh to ~1.1 crore this fiscal year, against the earlier ~45 lakh.
“With such investments gaining approvals, every player will come on the ground with a surprise strategy to reap long-term results,” Srivastava said.
An important factor will aid them. After the UK’s approval for Viagra as an Over-the-counter (OTC) product, it is expected that the US would follow suit considering the highly motivated patient population.
“Many among these seven companies have been waiting to get into the US OTC market considering its sheer volume. Now, they are likely to have the opportunity,” Chatterjee said.
THE PHARMACY BENEFIT MANAGERS ROUTE
The Indian manufacturers are expected to tie up with the PBMs, which managed pharmacy benefits for 26.6 crore Americans in 2016. “These PBMs operate inside of integrated healthcare systems as part of retail pharmacies, and as part of insurance companies. The success of Indian firms will depend on their relationship and networking with these pharmacy chains,” said Indian Drug Manufacturers’ Association executive director Ashok Madan.
Most of the firms remained tight-lipped about their plans. Dr. Reddy’s Laboratories said its spokesperson was travelling, emails sent to Cadila Healthcare, Torrent Pharmaceuticals, Rubicon Research went unanswered.
An Ajanta Pharma official, who requested anonymity, said they had just two US approvals until 2014. “In 2016, we had nine new approvals. We are upping our ante to expand the business in the US. Whenever a drug loses a patent, it is a big opportunity. However, we are still working on the strategies.”