FDA Orange Book · active-ingredient family
Etravirine
Etravirine: 1 brand, 3 generics; first approved Jan 18, 2008; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
0
Presentations
10
Brand (NDA) products
Originator applications
- INTELENCERLDJANSSEN R AND DNDA 02218720123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx —
Generic (ANDA) products (3)
Abbreviated applications
- ETRAVIRINEBIONPHARMAANDA 21915220252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - ETRAVIRINECARNEGIEANDA 21540220222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - ETRAVIRINEAMNEALANDA 21419620213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB
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
18 yr 10 mo ago
Most recent approval
10 mo ago
Approvals span 2008–2025 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Etravirine: 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.
