FDA Orange Book · active-ingredient family
Efavirenz
Efavirenz: 2 brands, 9 generics; first approved Sep 17, 1998; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
9
Listed patents
0
Presentations
16
Brand (NDA) products
Originator applications
- SUSTIVARLDBRISTOL MYERS SQUIBBNDA 02136020022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Discontinued — 600MG TABLET ORAL Discontinued — - SUSTIVARLDBRISTOL MYERS SQUIBBNDA 02097219983 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (9)
Abbreviated applications
- EFAVIRENZMACLEODS PHARMS LTDANDA 0915792024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - EFAVIRENZSTRIDES PHARMAANDA 0785092021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — - EFAVIRENZAUROBINDO PHARMA LTDANDA 0776732018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - EFAVIRENZAUROBINDO PHARMAANDA 2053222018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — - EFAVIRENZCIPLAANDA 2047662018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - EFAVIRENZRSHETERO LABS LTD IIIANDA 0788862018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - EFAVIRENZPHARMOBEDIENTANDA 2048692018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB - EFAVIRENZAUROBINDO PHARMAANDA 07806420173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx — 100MG CAPSULE ORAL Rx — 200MG CAPSULE ORAL Rx — - EFAVIRENZMYLANANDA 0914712016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
28 yr 4 mo ago
Most recent approval
2 yr 4 mo ago
Approvals span 1998–2024 across 11 FDA applications.
Brand (NDA) 218%
Generic (ANDA) 982%
Efavirenz: 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.
