When was Viagra introduced to the market? In 1998. The US Food and Drug Administration (FDA) approved it on 27 March 1998, Viagra 25, 50 and 100 mg tablets were entered on the Australian Register of Therapeutic Goods on 4 September 1998, and the European Union authorised it ten days later, on 14 September 1998. Those are the official approval dates; none of the records gives the day the first pack was sold in each country.
When was Viagra approved in the United States?
On 27 March 1998. The FDA's Drugs@FDA database lists VIAGRA (sildenafil citrate) tablets under application NDA 020895, first approved on 27 March 1998 (Drugs@FDA — Viagra). A 2006 history of the medicine, co-written by Ian Osterloh, who was responsible for Viagra's clinical development at Pfizer, gives the same month: "The FDA approved Viagra for the treatment of men with ED in March 1998" (Ghofrani et al., Nature Reviews Drug Discovery, 2006).
When did Viagra reach Australia?
In September 1998. Viagra 25, 50 and 100 mg tablets were entered on the Australian Register of Therapeutic Goods (ARTG) on 4 September 1998, as entries 64434, 64435 and 64436 (ARTG search). The same numbers are on the Australian packs today, as "AUST R 64434", "AUST R 64435" and "AUST R 64436", and the leaflet now names Viatris Pty Ltd as the distributor (Viagra CMI). Like every medicine for erectile dysfunction here, it needs a prescription: "In Australia, you need a prescription to get ED medicines" (healthdirect).
When was Viagra approved in Europe?
On 14 September 1998. The European product information for Viagra gives its "Date of first authorisation: 14 September 1998" (EMA — Viagra product information), and the 2006 history agrees: "European approval followed in September 1998" (Ghofrani et al.).
| Date | Where | What the record says | Record |
|---|---|---|---|
| 27 March 1998 | United States | FDA original approval, VIAGRA tablets, NDA 020895 | Drugs@FDA |
| 4 September 1998 | Australia | VIAGRA 25, 50 and 100 mg entered on the ARTG (64434–64436) | ARTG |
| 14 September 1998 | European Union | Date of first authorisation | EMA |
How quickly did doctors start prescribing it?
Within weeks in the United States. The 2006 history reports that "within a few weeks of the introduction of Viagra to the US market more than one million patients had received prescriptions for sildenafil", and that "The first-line treatment of ED began to move from specialists, such as urologists and psychiatrists, to a general practice setting" (Ghofrani et al.). The sources we read give no comparable figure for Australia, so we give none.
What did men use before Viagra?
Treatments applied to the penis itself. A 2019 review of the medicine's story lists them: surgery, vacuum pumps, injections and suppositories placed in the urethra (Goldstein et al., Sexual Medicine Reviews, 2019). Viagra was a tablet, taken by mouth before sex. Some of the older treatments are still used when tablets don't suit: healthdirect lists alprostadil injections and vacuum erection devices among the alternatives (healthdirect).
When did generic versions reach the market?
In the United States, on 11 December 2017, not in 2016 as this page used to say. Under a settlement with Pfizer, "Teva will be allowed to launch a generic version of Viagra® in the United States on December 11, 2017, or earlier under certain circumstances", and Pfizer's US patent on the use of Viagra for erectile dysfunction ran until April 2020, a date that includes a period of paediatric exclusivity (Pfizer, 17 December 2013). Teva announced the launch on that day (Teva, 11 December 2017); the full story is on is generic Viagra available in the USA? In Australia, a search of the ARTG for "sildenafil" returns 78 entries today (ARTG search); the sources we read do not say when the first generic was entered, so we give no date.
The short answer
Viagra reached the market in 1998: approved in the United States on 27 March, entered on the Australian register on 4 September, and authorised in the European Union on 14 September. How it was found is told in how was Viagra discovered?, what it was first meant to treat in what was Viagra's original purpose?, and the whole timeline in our history of Viagra.
