FDA Orange Book · active-ingredient family
Efavirenz; emtricitabine; tenofovir disoproxil fumarate
Efavirenz; emtricitabine; tenofovir disoproxil fumarate: 1 brand, 8 generics; first approved Jul 12, 2006; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
8
Listed patents
3
Next patent expiry
Jun 13, 2026
2 mo ago
Brand (NDA) products
Originator applications
- ATRIPLARLDGILEAD SCIENCESNDA 0219372006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG;200MG;300MG TABLET ORAL Discontinued —
Generic (ANDA) products (8)
Abbreviated applications
- EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATEMYLANANDA 2090612024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG;200MG;300MG TABLET ORAL Discontinued — - CHARTWELL RXANDA 2018022023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG;200MG;300MG TABLET ORAL Discontinued — - HETERO LABS LTD VANDA 2030532022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG;200MG;300MG TABLET ORAL Rx AB - LAURUSANDA 2135412021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG;200MG;300MG TABLET ORAL Rx AB - MACLEODS PHARMS LTDANDA 2042872021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG;200MG;300MG TABLET ORAL Rx AB - CIPLAANDA 2068942019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG;200MG;300MG TABLET ORAL Rx AB - TEVA PHARMS USAANDA 0912152018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG;200MG;300MG TABLET ORAL Rx AB - AUROBINDO PHARMAANDA 2030412018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG;200MG;300MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9018192 | 2 mo ago | U-750 | |
| 9545414 | 2 mo ago | ProductU-1170 | |
| 8598185 | in 2 yr 9 mo | Product |
Approval history
FDA approval span
First approval
20 yr 5 mo ago
Most recent approval
2 yr ago
Approvals span 2006–2024 across 9 FDA applications.
Brand (NDA) 111%
Generic (ANDA) 889%
Efavirenz; emtricitabine; tenofovir disoproxil 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.
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- 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.
