FDA Orange Book · active-ingredient family
Ambrisentan
Ambrisentan: 1 brand, 9 generics; first approved Jun 15, 2007; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
9
Listed patents
3
Next patent expiry
Dec 11, 2027
in 1 yr 4 mo
Brand (NDA) products
Originator applications
- LETAIRISRLDGILEADNDA 02208120072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB
Generic (ANDA) products (9)
Abbreviated applications
- AMBRISENTANAUROBINDO PHARMAANDA 21653120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - AMBRISENTANAPOTEXANDA 21070120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - AMBRISENTANCIPLAANDA 21071520192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - AMBRISENTANPH HEALTHANDA 20950920192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - AMBRISENTANSIGMAPHARM LABS LLCANDA 20835420192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - AMBRISENTANMYLANANDA 20844120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - AMBRISENTANSUN PHARMANDA 21078420192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - AMBRISENTANWATSON LABS INCANDA 20825220192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - AMBRISENTANZYDUS PHARMSANDA 21005820192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9474752 | in 1 yr 4 mo | U-1754 | |
| 8377933 | in 1 yr 4 mo | U-1754 | |
| 9549926 | in 5 yr 3 mo | U-1965 |
Approval history
FDA approval span
First approval
19 yr 5 mo ago
Most recent approval
4 yr 2 mo ago
Approvals span 2007–2022 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Ambrisentan: 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.
