Sildenafil
As of the edition of 20 October 2026, Sildenafil is a small molecule: marketed, first approved in 1998 (US); acts on PDE5A; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Viagra
- First approved
- 27 March 1998 (US)
- Approvals on record
- 17 in 6 regions
- Holder of the most recent approval
- IBSA Institut Biochimique; 7 holders in all
- Withdrawn from market
- 15 September 2003 (in some regions)
- Registered trials
- 272, 47 stopped early
- Disease areas
- Lungs and airways; Urinary and reproductive; Heart and blood vessels; Mental health; Inherited and neonatal; Nervous system
US protection
US protection ends in 2030.
The last listed US exclusivity ends in 2030. The application that gives this date is held by Viatris.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product4 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
3 companies on route B and 1 company on route A because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Sildenafil.
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Companies on route A for this drug
In the product1 company is on route A because of Sildenafil.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| PDE5A | cGMP-specific 3',5'-cyclic phosphodiesterase | O76074 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 47 | 25 | 0 | 8 |
| Phase 1 | 45 | 32 | 3 | 5 |
| Phase 2 | 62 | 37 | 8 | 14 |
| Phase 3 | 48 | 23 | 3 | 10 |
| Phase 4 | 70 | 46 | 4 | 10 |
| All trials | 272 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator and Lead sponsor of trials | 1998 to now |
| Viatris | Acquired holder and Lead sponsor of trials | 1998 to now |
| IBSA Institut Biochimique | Applicant and Lead sponsor of trials | 2016 to now |
| Cmp | Later holder | 2023 to now |