Is generic Viagra available in the USA? Yes, since 11 December 2017, when Teva launched the first generic version of Viagra tablets there under a patent settlement with Pfizer, and Pfizer's own generics business launched one the same week. This page is the history of how that happened. In Australia, generic sildenafil is on the register and, like Viagra, needs a prescription.
When did generic Viagra go on sale in the USA?
In the week of 11 December 2017. That day Teva announced "the exclusive launch of its generic Viagra® (sildenafil citrate) tablets in the U.S." (Teva, 11 December 2017). A trade report the next day summed up the week: "The first generic versions of Viagra … were launched this week in the United States by Teva Pharmaceutical Industries Ltd. and Greenstone LLC" (Chain Drug Review, 12 December 2017). The FDA had approved Teva's sildenafil 25, 50 and 100 mg tablets on 9 March 2016 (Drugs@FDA, ANDA 077342); the launch waited for the date agreed with Pfizer.
Why did it take until December 2017?
Because of a court settlement. On 17 December 2013 Pfizer announced that it had settled its case against Teva over the patent covering the use of Viagra to treat erectile dysfunction, and that "Teva will be allowed to launch a generic version of Viagra® in the United States on December 11, 2017, or earlier under certain circumstances", paying Pfizer a royalty for a licence (Pfizer, 17 December 2013). The date came from that agreement, not from the patent running out.
Did Pfizer sell its own generic?
Yes. Greenstone, a Pfizer subsidiary, launched sildenafil citrate 25, 50 and 100 mg tablets in the same week as Teva, as the authorised generic of Viagra: the brand owner's own medicine under its generic name (Chain Drug Review, 12 December 2017).
Did more generics follow?
Yes, in 2018. The FDA approved sildenafil 25, 50 and 100 mg tablets from four more companies on 11 June 2018, then from two more later that year. The dates, from the FDA's own records:
| Date | What happened | Record |
|---|---|---|
| 17 December 2013 | Pfizer and Teva settle the US patent case; Teva may launch on 11 December 2017 | Pfizer |
| 9 March 2016 | FDA approves Teva's sildenafil 25, 50 and 100 mg tablets | Drugs@FDA |
| 11 December 2017 | Teva launches; Greenstone (Pfizer) launches the authorised generic that week | Teva, Chain Drug Review |
| 11 June 2018 | FDA approves sildenafil tablets from Aurobindo, Hetero, Rubicon Research and Torrent | Aurobindo, Hetero, Rubicon, Torrent |
| 27 June 2018 | FDA approves Amneal's | Drugs@FDA |
| 12 October 2018 | FDA approves Ajanta's | Drugs@FDA |
| April 2020 | Pfizer's US patent on Viagra for erectile dysfunction expires | Pfizer |
An FDA approval date is not a launch date: the table records when each version was approved, not when it reached the market.
When did the US patent on Viagra expire?
In April 2020. Pfizer's 2013 announcement described its patent covering the use of Viagra to treat erectile dysfunction (the 25, 50 and 100 mg tablets) as one "which expires in April 2020", a date that includes a period of paediatric exclusivity (Pfizer, 17 December 2013). Generic versions were therefore on sale in the USA more than two years before the patent ended, because of the settlement.
Was there generic sildenafil in the USA before 2017?
Yes, but not in the Viagra strengths. The FDA approved generic sildenafil 20 mg tablets from November 2012, for example Torrent's on 6 November 2012 (Drugs@FDA, ANDA 091479). 20 mg is the tablet strength of Revatio, the sildenafil medicine for high blood pressure in the lungs (EMA — Revatio), not one of the 25, 50 and 100 mg strengths of Viagra.
What is the position in Australia?
Generic sildenafil is on the Australian register, and it needs a prescription. A search of the Australian Register of Therapeutic Goods for "sildenafil" returns 78 entries, from tablets to sublingual wafers (ARTG search, 26 September 2026). "In Australia, you need a prescription to get ED medicines" (healthdirect), and sildenafil "can only be supplied to Australians with a prescription" (TGA), whatever the brand. Whether a generic works like Viagra is answered in generic sildenafil vs Viagra.
The short answer
Yes. Generic sildenafil for erectile dysfunction has been sold in the USA since 11 December 2017, first by Teva and by Pfizer's own Greenstone, with more FDA approvals in 2018; Pfizer's US patent ran until April 2020. In Australia, generic sildenafil is on the register and prescription-only. How Viagra was discovered, and when it reached Australia, is in our history of Viagra.
