FDA Orange Book · active-ingredient family
Emtricitabine; tenofovir alafenamide fumarate
Emtricitabine; tenofovir alafenamide fumarate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DESCOVY · NDA 208215
1
Brand (NDA)
3
Generics (ANDA)
6
Listed patents
3
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DESCOVYRLD×2 | GILEAD SCIENCES INC | NDA 208215 | — | Jan 07, 2022 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE | MACLEODS PHARMS LTD | ANDA 214216 | AB | Apr 07, 2026 | |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE | LUPIN | ANDA 213926 | — | Dec 13, 2024 | |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE×2 | APOTEX | ANDA 214053 | — | May 17, 2024 |
Marketing exclusivity (3)
- M-316New use / labeling-change exclusivity (3 years)
Jun 20, 2028
in 2 yr
- ODE-457Orphan-drug exclusivity (7 years)
Jan 07, 2029
in 2 yr 7 mo
- M-316New use / labeling-change exclusivity (3 years)
Jun 20, 2028
in 2 yr
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8754065 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-1663 |
| 9296769 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-1663 |
| 8754065*PED | Feb 15, 2033 | in 6 yr 9 mo | |
| 9296769*PED | Feb 15, 2033 | in 6 yr 9 mo | |
| 12648911 | Jun 29, 2036 | in 10 yr 2 mo | U-1663 |
| 12629338 | Jun 29, 2036 | in 10 yr 2 mo | Product |
Emtricitabine; tenofovir alafenamide fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
