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FDA Orange Book · active-ingredient family

Aprepitant

Aprepitant is approved as 4 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:APONVIE · NDA 216457

4

Brand (NDA)

4

Generics (ANDA)

15

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, emulsion, for suspension

ProductApplicantApplicationTEApproved
APONVIERLDHERON THERAPS INCNDA 216457—Sep 16, 2022
CINVANTIRLDHERON THERAPS INCNDA 209296—Nov 09, 2017
EMENDRLDMSD MERCK CONDA 207865—Dec 17, 2015
EMENDRLD×3MSDNDA 021549—Jun 30, 2006

Generic (ANDA) products (4)

ProductApplicantApplicationTEApproved
APREPITANTMYLANANDA 218851—Mar 05, 2026
APREPITANT×3TORRENTANDA 211835ABOct 21, 2020
APREPITANT×3GLENMARK SPECLTANDA 207777ABOct 12, 2017
APREPITANT×3SANDOZANDA 090999ABSep 24, 2012

Listed patents (15)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8258132Sep 26, 2027in 1 yr 3 mo
ProductU-901
10953018Sep 18, 2035in 9 yr 5 mo
U-3440
10624850Sep 18, 2035in 9 yr 5 mo
U-3440
9974794Sep 18, 2035in 9 yr 5 mo
ProductU-3440
9808465Sep 18, 2035in 9 yr 5 mo
U-3440
9561229Sep 18, 2035in 9 yr 5 mo
ProductU-3440
11744800Sep 18, 2035in 9 yr 5 mo
ProductU-3690
11878074Sep 18, 2035in 9 yr 5 mo
U-3787
10500208Sep 18, 2035in 9 yr 5 mo
Product
9974793Sep 18, 2035in 9 yr 5 mo
Product
12290520Sep 18, 2035in 9 yr 5 mo
Product
12115254Sep 18, 2035in 9 yr 5 mo
Product
9974742Sep 18, 2035in 9 yr 5 mo
Product
11173118Sep 18, 2035in 9 yr 5 mo
Product
12115255Sep 18, 2035in 9 yr 5 mo
Product

Aprepitant — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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