FDA Orange Book · active-ingredient family
Aprepitant
Aprepitant: 5 brands, 4 generics; first approved Mar 26, 2003; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
5
Generics (ANDA)
4
Listed patents
15
Next patent expiry
Sep 26, 2027
in 1 yr 1 mo
Brand (NDA) products
Originator applications
- APREPITANTRLDRSAZURITYNDA 2187542026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 130MG/18ML (7.2MG/ML) EMULSION INTRAVENOUS Rx — - HERON THERAPS INCNDA 2164572022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 32MG/4.4ML (7.2MG/ML) EMULSION INTRAVENOUS Rx — - HERON THERAPS INCNDA 2092962017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 130MG/18ML (7.2MG/ML) EMULSION INTRAVENOUS Rx — - MSD MERCK CONDA 2078652015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/KIT FOR SUSPENSION ORAL Rx — - EMENDRLDMSDNDA 02154920063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG CAPSULE ORAL Rx AB 125MG CAPSULE ORAL Rx AB 40MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (4)
Abbreviated applications
- APREPITANTMYLANANDA 2188512026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 32MG/4.4ML (7.2MG/ML) EMULSION INTRAVENOUS Discontinued — - APREPITANTTORRENTANDA 21183520203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG CAPSULE ORAL Rx AB 80MG CAPSULE ORAL Rx AB 125MG CAPSULE ORAL Rx AB - APREPITANTGLENMARK SPECLTANDA 20777720173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG CAPSULE ORAL Rx AB 80MG CAPSULE ORAL Rx AB 125MG CAPSULE ORAL Rx AB - APREPITANTSANDOZANDA 09099920123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG CAPSULE ORAL Rx AB 80MG CAPSULE ORAL Rx AB 125MG CAPSULE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8258132 | in 1 yr 1 mo | ProductU-901 | |
| 10953018 | in 9 yr 3 mo | U-3440 | |
| 10624850 | in 9 yr 3 mo | U-3440 | |
| 9974794 | in 9 yr 3 mo | ProductU-3440 | |
| 9808465 | in 9 yr 3 mo | U-3440 | |
| 9561229 | in 9 yr 3 mo | ProductU-3440 | |
| 11744800 | in 9 yr 3 mo | ProductU-3690 | |
| 11878074 | in 9 yr 3 mo | U-3787 | |
| 10500208 | in 9 yr 3 mo | Product | |
| 9974793 | in 9 yr 3 mo | Product | |
| 12290520 | in 9 yr 3 mo | Product | |
| 12115254 | in 9 yr 3 mo | Product | |
| 9974742 | in 9 yr 3 mo | Product | |
| 11173118 | in 9 yr 3 mo | Product | |
| 12115255 | in 9 yr 3 mo | Product |
Approval history
FDA approval span
First approval
23 yr 9 mo ago
Most recent approval
2 mo ago
Approvals span 2003–2026 across 9 FDA applications.
Brand (NDA) 556%
Generic (ANDA) 444%
Aprepitant: 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.
