sildenafil citrate · Viatris · NDA 021845, 022473, 203109
Revatio
Earliest generic entry, as listed · earliest of 2 marketed strengths
31 Jan 2030
1 of 2 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by exclusivity: ODE-469.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| ODE-469 | orphan drug (7 years) | 31 Jan 2030 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021845 · 001 · RLD | tablet, oral | EQ 20MG BASE | 31 Jan 2030 |
| 022473 · 001 · RLD | solution, intravenous | EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) | open |
| 203109 · 001 · RLD · discontinued | for suspension, oral | EQ 10MG BASE/ML | open |
Expired or delisted (1)
- M-287 · 31 Jan 2026