vardenafil hydrochloride · Bayer Hlthcare · NDA 021400
Levitra
Earliest generic entry, as listed · earliest of 4 marketed strengths
23 Jul 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8273876. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8273876 | use U-1288 | 23 Jul 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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
- 24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021400-00423 Jul 2027
- 24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021400-00223 Jul 2027
- 24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021400-00123 Jul 2027
- 24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021400-00323 Jul 2027
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021400 · 001 · RLD · discontinued | tablet, oral | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 23 Jul 2027 |
| 021400 · 002 · RLD · discontinued | tablet, oral | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 23 Jul 2027 |
| 021400 · 003 · RLD · discontinued | tablet, oral | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 23 Jul 2027 |
| 021400 · 004 · RLD · discontinued | tablet, oral | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 23 Jul 2027 |