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FDA Orange Book · active-ingredient family

Sufentanil citrate

Sufentanil citrate is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DSUVIA · NDA 209128

2

Brand (NDA)

3

Generics (ANDA)

21

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, tablet

ProductApplicantApplicationTEApproved
DSUVIARLDVERTICAL PHARMSNDA 209128—Nov 02, 2018
SUFENTA PRESERVATIVE FREERLDRISINGNDA 019050APMay 04, 1984

Generic (ANDA) products (3)

ProductApplicantApplicationTEApproved
SUFENTANIL CITRATEHOSPIRAANDA 074534APDec 11, 1996
SUFENTANIL CITRATEHIKMAANDA 074413—Dec 15, 1995
SUFENTANIL CITRATEWATSON LABSANDA 074406—Dec 15, 1995

Listed patents (21)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8778393Jan 05, 2027in 7 mo
U-1351
9320710Jan 05, 2027in 7 mo
U-1351
8226978Jan 05, 2027in 7 mo
ProductU-1351
8865211Jan 05, 2027in 7 mo
U-1351
10245228Jan 05, 2027in 7 mo
ProductU-1351
10507180Jan 05, 2027in 7 mo
ProductU-1351
8535714Jan 05, 2027in 7 mo
ProductU-1351
8778394Jan 05, 2027in 7 mo
U-1351
9744129Jan 05, 2027in 7 mo
Product
8252329Jan 05, 2027in 7 mo
Product
10342762Jan 05, 2027in 7 mo
Product
8252328Jan 05, 2027in 7 mo
Product
8231900Jan 05, 2027in 7 mo
Product
12033733Mar 16, 2030in 3 yr 10 mo
Product
10896751Mar 16, 2030in 3 yr 10 mo
Product
8574189Mar 16, 2030in 3 yr 10 mo
Product
11676691Mar 16, 2030in 3 yr 10 mo
Product
8202535Oct 22, 2030in 4 yr 5 mo
U-1351
8865743Oct 22, 2030in 4 yr 5 mo
U-1351
8945592Jul 29, 2031in 5 yr 2 mo
Product
11672738Feb 02, 2038in 11 yr 10 mo
Product

Sufentanil citrate — frequently asked questions

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

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