Getting a chemically-induced erection is about to become much cheaper, as pharmaceutical giant Pfizer’s patent on its blockbuster erectile dysfunction (ED) drug, Viagra, expires in April 2020.
Approximately one in ten adult males will suffer from ED on a long-term basis, with many more suffering the occasional “letdown.” Moreover, recreational Viagra use – including mixing the drug with others such as ecstasy, has been on the rise.
Genuine Viagra costs around $65 per pill in the US, while Pfizer struck a deal with Teva Pharmaceuticals in 2007 for a half-price generic version. That said, it’s about to get much cheaper to get it up.
India rises to the occasion
Looking to cash in on the patent expiration are several companies located in India, reports the Hindustan Times.
Seven Indian companies have already secured the required permissions. They are among 15 companies worldwide that have been granted approval by US health watchdog the Food and Drug Administration, to produce sildenafil citrate, the formulation patented as Viagra.
The Indian companies in the fray to sell the blue pill are Rubicon Research, Hetero Drugs, Macleods Pharma, Dr.Reddy’s, Aurobindo Pharma, Torrent Pharmaceuticals and Ajanta Pharma.
Could spark massive price crash in the US
The Indian companies are working on strategies that could bring down the price of Viagra in the US market by almost 99 per cent. –Hindustan Times
Mumbai-based Macleods Pharmaceuticals, for example, sells a generic version of Viagra for .85c/tablet. Another, Ajanta Pharma, a $1.6 billion publicly-listed firm, sells its own version in India for .47 cents each.
Pfizer’s global sales from Viagra alone was $1.685 billion in 2014, according to Transparency Market Research, while the gobal market for ED drugs was valued at $4.35 billion in 2016.
“Lower pricing is the only way to gain preference. Hence, a price war is certain,” said Macleods Pharma VP Niteesh Srivastava, who admitted that Indian competition will likely spark fierce competition. “While lesser known or relatively smaller firms will be able to crash prices due to less overhead expenditures, pharma giants will already have a better hold on the pharmacy benefit managers (PBMs) in the US to reach the desired negotiations,” he added.
“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, reports the Times.
That said, it may not be a walk in the park, as Indian firms will need to contend with rising FDA license fees to around $160,000 USD for the fiscal year 2018, up from roughly $65,000.
“With such investments to gain approvals, every player will come on the ground with a surprise strategy to reap long-term results,” Srivastav said.
Indian firms are also hoping the FDA will follow the United Kingdom’s decision to allow Viagra to be sold over the counter without a prescription.
“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.
Next steps
In anticipation of entry into the US market, Indian manufacturers will begin establishing relationships with pharmacy benefit managers (PBMs) in the United States – which are “primarily responsible for developing and maintaining the formulary, contracting with pharmacies, negotiating discounts and rebates with drug manufacturers, and processing and paying prescription drug claims,” according to the American Pharmacists Association.
In 2016, PBMs managed pharmacy benefits for 26.6 crore Americans. “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 Ashok Madan, executive director, Indian Drug Manufacturers’ Association, a lobby representing over 1,000 pharma companies in India.
Most of the companies, however, remained tight-lipped about their plans. While Dr. Reddy’s Laboratories said its spokesperson is traveling, emails sent to Cadila Healthcare, Torrent Pharmaceuticals, Rubicon Research did not elicit a response. –Hindustan Times
“We 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,” said an official from Ajanta Pharma on condition of anonymity.
Whatever the case and however many hurdles India’s pharmaceutical industry needs to jump through – suffice to say, it’s going to be a lot cheaper to get your boner on in the next few years.
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