FDA Orange Book · active-ingredient family
Emtricitabine; tenofovir alafenamide fumarate
Emtricitabine; tenofovir alafenamide fumarate: 1 brand, 4 generics; first approved Apr 04, 2016; generic available.
Generic available5 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
4
Listed patents
8
Next patent expiry
Aug 15, 2032
in 6 yr
Brand (NDA) products
Originator applications
- DESCOVYRLDGILEAD SCIENCES INCNDA 20821520222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG;EQ 25MG BASE TABLET ORAL Rx AB 120MG;EQ 15MG BASE TABLET ORAL Rx —
Generic (ANDA) products (4)
Abbreviated applications
- NATCOANDA 2141732026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG;EQ 25MG BASE TABLET ORAL Rx AB - MACLEODS PHARMSANDA 2142162026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG;EQ 25MG BASE TABLET ORAL Rx AB - LUPINANDA 2139262024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG;EQ 25MG BASE TABLET ORAL Discontinued — - APOTEXANDA 21405320242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG;EQ 15MG BASE TABLET ORAL Discontinued — 200MG;EQ 25MG BASE TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- M-316New use / labeling-change exclusivity (3 years)
in 1 yr 9 mo
- ODE-554Orphan-drug exclusivity (7 years)
in 2 yr 4 mo
- ODE-556Orphan-drug exclusivity (7 years)
in 5 yr 10 mo
- M-316New use / labeling-change exclusivity (3 years)
in 1 yr 9 mo
- ODE-556Orphan-drug exclusivity (7 years)
in 5 yr 10 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8754065 | in 6 yr | SubstanceProductU-1663 | |
| 9296769 | in 6 yr | SubstanceProductU-1663 | |
| 8754065*PED | in 6 yr 6 mo | ||
| 9296769*PED | in 6 yr 6 mo | ||
| 12661323 | in 9 yr 11 mo | Product | |
| 12648911 | in 9 yr 11 mo | U-1663 | |
| 12629338 | in 9 yr 11 mo | Product | |
| 12678408 | in 9 yr 11 mo | Product |
Approval history
FDA approval span
First approval
10 yr 7 mo ago
Most recent approval
27 d ago
Approvals span 2016–2026 across 5 FDA applications.
Brand (NDA) 120%
Generic (ANDA) 480%
Emtricitabine; tenofovir alafenamide fumarate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
