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NEW YORK — The first generic versions of Viagra, Pfizer Inc.’s blockbuster drug for erectile dysfunction, were launched this week in the United States by Teva Pharmaceutical Industries Ltd. and Greenstone LLC.
Israel-based Teva said it’s offering sildenafil citrate tablets in dosages of 25 mg, 50 mg and 100 mg. Greenstone, a Peapack, N.J.-based Pfizer subsidiary, said its sildenafil citrate tablets are available in strengths of 25 mg, 50 mg and 100 mg and are the authorized generic of Viagra.
Viagra totaled U.S. sales of approximately $1.4 billion in the 12 months through August, according to data from IQVIA reported by Teva.
“The launch of Teva’s sildenafil tablets brings an affordable generic treatment option to the estimated 18 million men in the U.S. who are diagnosed with erectile dysfunction,” stated Brendan O’Grady, executive vice president of North America commercial at Teva. “Our team has made it a priority to ensure that patients are able to access this medicine, through both traditional and more innovative channels.”
Teva said it’s providing patient support services for its generic Viagra, such as a sildenafil tablets savings card in which users may pay as little as $0 out-of-pocket, with a maximum benefit of up to $100 per fill, for up to six sildenafil tablet prescriptions.
The company also has launched a website, TevaSildenafil.com, with information on how patients can order their medicine online and have it shipped direct as well as on how to get it via traditional retail channels. Patients also can call Teva customer service at 1-888 TEVA USA for help in finding a nearby pharmacy that carries its sildenafil tablets and can fill their prescription.
In late 2013, Teva and Pfizer reached a settlement to resolve patent litigation on Teva’s generic for Viagra. Under the agreement, Teva was cleared to launch a Viagra generic in the U.S. on Dec. 11, 2017. Teva will pay Pfizer a royalty for a license to produce its generic version.
Pfizer’s patent covering the use of Viagra (sildenafil citrate 25-, 50- and 100-mg tablets) is slated to expire in April 2020. Mylan N.V. reached a settlement with Pfizer in April 2015 that will enable it to introduce generic Viagra in December 2017.
Other companies that have filed Abbreviated New Drug Applications (ANDAs) with the Food and Drug Administration for generic sildenafil citrate tablets include Aurobindo, Amneal, Dr. Reddy’s, Apotex and Ajanta Pharma, among others.
