Lupin gets nod to sell generic form of Viagra in the US

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Pharmaceutical major Lupin said that it has received approval from the United States Food and Drug Administration for the sales of a generic equivalent of Pfizer Inc’s Viagra tablets.

Sildenafil tablets is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is taken by mouth or via injection into a vein.

Sildenafil tablets had an annual sales of around $611 million in the US market in the doses of 25 mg, 50 mg, and 100 mg.

Sildenafil was synthesized by a group of pharmaceutical chemists working at Pfizer’s Sandwich, Kent, research facility in England. It was initially studied for use in hypertension (high blood pressure) and angina pectoris (a symptom of ischaemic heart disease).

Phase I clinical trials under the direction of Ian Osterloh suggested the drug had little effect on angina, but it could induce marked penile erections. Pfizer decided to market it for erectile dysfunction, rather than for angina.

The drug was patented in 1996, approved for use in erectile dysfunction by the FDA on 27 March 1998, becoming the first oral treatment approved to treat erectile dysfunction in the United States, and offered for sale in the United States later that year.

Annual sales of Viagra peaked in 2008 at US$1.934 billion.

Pfizer’s patents on Viagra expired outside the US in 2012. In December 2017, Pfizer released its own generic version of Viagra. The U.S. Food and Drug Administration has approved more than a dozen drug Manufacturers to market generic sildenafil in the United States, nearly half of whom are from India.

Lupin is one of the world’s biggest makers of generic drugs, and sells both branded and generic formulations, biotechnology products and pharmaceutical ingredients globally.

It is the world’s biggest manufacturer of anti-TB medicines and focuses on cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-infective and NSAID segments of the pharma market.

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