FDA Orange Book · active-ingredient family
Tenofovir alafenamide fumarate
Tenofovir alafenamide fumarate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VEMLIDY · NDA 208464
1
Brand (NDA)
2
Generics (ANDA)
4
Listed patents
1
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VEMLIDYRLD | GILEAD SCIENCES INC | NDA 208464 | AB | Nov 10, 2016 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TENOFOVIR ALAFENAMIDE FUMARATE | APOTEX | ANDA 213867 | — | Mar 21, 2024 | |
| TENOFOVIR ALAFENAMIDE | LUPIN | ANDA 214226 | AB | Mar 30, 2023 |
Marketing exclusivity (1)
- NPPNew patient population exclusivity (3 years)
Mar 27, 2027
in 9 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8754065 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-999 |
| 9296769 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-1275 |
| 9296769*PED | Feb 15, 2033 | in 6 yr 9 mo | |
| 8754065*PED | Feb 15, 2033 | in 6 yr 9 mo |
Tenofovir alafenamide fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
