On Monday, Lupin Limited, a Mumbai-based transnational pharmaceutical company, said it has received approval from the U.S. Food and Drug Administration (FDA) to sell a generic version of Viagra in the American market.
Sildenafil Citrate, the active drug of Viagra, is prescribed for the treatment of Erectile Dysfunction (ED).
The company has got the FDA approval to market its product, which is a generic version of Sildenafil Citrate, Pfizer Inc’s Viagra, said Lupin Ltd in a regulatory filing.
The Mumbai-based pharma company has received FDA approval to sell its generic version of Viagra in various strengths.
Sildenafil Citrate is a drug that belongs to the class of pharmacological agents called Phosphodiesterase-5 (PDE5) inhibitors. Other common PDE5 inhibitors include Tadalafil, Vardenafil, and Avanafil. The main function of the drug is to inhibit PDE5 enzyme in the body. Simply put, these drugs improve erection health in men by boosting blood flow to the penile organ.
The FDA approved Sildenafil Citrate in 1998 for the treatment of ED, although it was originally discovered for the treatment of pulmonary arterial hypertension.
Lupin sells generic Sildenafil Citrate tablets under the name Enthusia and Lupigra in 50 mg and 100 mg potencies.
Sildenafil tablets USP – 25 mg, 50 mg, and 100 mg – had annual sales of nearly $611 million in the American market, according to the data of IQVIA MAT December 2018. The shares of Lupin were trading 1.73 percent down at Rs. 730.65 per share on the Bombay Stock Exchange (BSE).
