Pfizers Viagra patent set to end in US, Indian Pharma eyes Opportunity

New Delhi: Pharma Giant Pfizer is soon going to lose patent of its blockbuster drug Viagra in the US and this indeed is coming as a strong opportunity to Indian firms to make their presence in the US market with their generic versions of the drug.

Viagra is the iconic blue pill that cures erectile dysfunction (impotence in men). It is manufactured by Pfizer and the firm is going to lose its patent in the US in 2020 , a development which will open the door for Indian companies to target the nearly 5 crore Americans who suffer from erectile dysfunction.

The Print has reported that 15 companies worldwide have been granted approval by US Food and Drug Administration (USFDA) to produce sildenafil citrate, the formulation patented as Viagra. Among these seven companies are Indian and include Rubicon Research, Hetero Drugs, Macleods Pharma, Dr Reddy’s, Aurobindo Pharma, Torrent Pharmaceuticals and Ajanta Pharma.

As in case of other drugs, competitive pricing will likely favor the Indian Drug makers. It has been reported that the pill by Pfizer costs about $65, or over Rs 4,400, in the US and the company itself had launched a generic version of the drug at half of the price in 2017.

On the other hand, Indian companies already sell desi versions of Viagra at as low a price as Rs 32. The Indian entry could dent Pfizer’s stranglehold on the drug.

According to the report, Macleods Pharmaceuticals, a Mumbai-based firm started its medicinal exports to the US in 2012 and sells a generic version of Viagra in India as Macsutra for Rs 58 per tablet. Whereas, Ajanta Pharma sells its version in India under the brand name Kamagra for Rs 32 a tablet.

Its global sales from just Viagra touched $1.685 billion, over Rs 10,900 crore, in 2014. According to an American company, Transparency Market Research, the global erectile dysfunction drugs market was valued at $4.35 billion in 2016 quotes the Print.

Niteesh Srivastava, vice president, Macleods Pharmaceuticals told the Print, “Lower pricing is the only way to gain preference. Hence, a price war is certain. 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.”

An official from Ajanta Pharma who requested anonymity told the Print, “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.”

Having said that, the Indian firms would have the major hurdle of rising FDA license fees. The FDA has increased the fee for processing drug applications by over Rs 65 lakh to Rs 1.1 crore for the fiscal year 2018, against the earlier fee of Rs 45 lakh.