tenofovir alafenamide fumarate · Gilead Sciences Inc · NDA 208464
Vemlidy
Earliest generic entry, as listed
15 Feb 2033
Blocked by patent: US 8754065, US 9296769.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8754065 | — | 15 Feb 2033 |
| US 9296769 | — | 15 Feb 2033 |
| US 8754065 | substance, product, use U-3880 | 15 Aug 2032 |
| US 8754065 | substance, product, use U-999 | 15 Aug 2032 |
| US 8754065 | substance, product, use U-1275 | 15 Aug 2032 |
| US 9296769 | substance, product, use U-999 | 15 Aug 2032 |
| US 9296769 | substance, product, use U-3880 | 15 Aug 2032 |
| US 9296769 | substance, product, use U-1275 | 15 Aug 2032 |
Exclusivities · 1 unexpired
| NPP | new patient population | 27 Mar 2027 |
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
- 25 Oct 2026Generic tentatively approved · 208464-0019 Jul 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208464 · 001 · RLD | tablet, oral | EQ 25MG BASE | 15 Feb 2033 |