FDA Orange Book · active-ingredient family
Fentanyl citrate
Fentanyl citrate: 10 brands, 12 generics; first approved Jul 11, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
10
Generics (ANDA)
12
Listed patents
4
Next patent expiry
Jul 23, 2027
in 11 mo
Brand (NDA) products
Originator applications
- FENTANYL CITRATERLDEXELA PHARMANDA 21587020232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) SOLUTION INTRAVENOUS Discontinued — EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION INTRAVENOUS Discontinued — - FENTANYL CITRATERLDRSHIKMANDA 01910120232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05MG BASE/ML INJECTABLE INJECTION Rx AP EQ 0.025MG BASE/0.5ML INJECTABLE INJECTION Rx — - LAZANDARLDBTCP PHARMANDA 02256920113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE SPRAY, METERED NASAL Discontinued — EQ 0.4MG BASE SPRAY, METERED NASAL Discontinued — EQ 0.3MG BASE SPRAY, METERED NASAL Discontinued — - ABSTRALRLDSENTYNL THERAPS INCNDA 02251020116 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE TABLET SUBLINGUAL Discontinued — EQ 0.2MG BASE TABLET SUBLINGUAL Discontinued — EQ 0.3MG BASE TABLET SUBLINGUAL Discontinued — EQ 0.4MG BASE TABLET SUBLINGUAL Discontinued — EQ 0.6MG BASE TABLET SUBLINGUAL Discontinued — EQ 0.8MG BASE TABLET SUBLINGUAL Discontinued — - FENTORARLDCEPHALONNDA 02194720066 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.2MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.4MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.6MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.8MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.3MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — - ACTIQRLDCEPHALONNDA 02074719986 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.2MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 0.4MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 0.6MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 0.8MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 1.2MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 1.6MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — - RISINGNDA 016619—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05MG BASE/ML INJECTABLE INJECTION Rx AP - ADALVONDA 02226620095 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.2MG BASE FILM BUCCAL Discontinued — EQ 0.4MG BASE FILM BUCCAL Discontinued — EQ 0.6MG BASE FILM BUCCAL Discontinued — EQ 0.8MG BASE FILM BUCCAL Discontinued — EQ 1.2MG BASE FILM BUCCAL Discontinued — - CEPHALONNDA 02019519954 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.2MG BASE TROCHE/LOZENGE ORAL Discontinued — EQ 0.3MG BASE TROCHE/LOZENGE ORAL Discontinued — EQ 0.4MG BASE TROCHE/LOZENGE ORAL Discontinued — EQ 0.1MG BASE TROCHE/LOZENGE ORAL Discontinued — - FENTANYL CITRATEHOSPIRANDA 0191151985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05MG BASE/ML INJECTABLE INJECTION Rx AP
Generic (ANDA) products (12)
Abbreviated applications
- FENTANYL CITRATEDR REDDYS LABS SAANDA 20632920226 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.2MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.3MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.4MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.6MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.8MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — - FENTANYL CITRATEFRESENIUS KABI USAANDA 2120862020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05MG BASE/ML INJECTABLE INJECTION Rx AP - FRESENIUS KABI USAANDA 2107622019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05MG BASE/ML INJECTABLE INJECTION Rx AP - FENTANYL CITRATEACTAVIS LABS FL INCANDA 20733820176 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE TABLET SUBLINGUAL Discontinued — EQ 0.2MG BASE TABLET SUBLINGUAL Discontinued — EQ 0.3MG BASE TABLET SUBLINGUAL Discontinued — EQ 0.4MG BASE TABLET SUBLINGUAL Discontinued — EQ 0.6MG BASE TABLET SUBLINGUAL Discontinued — EQ 0.8MG BASE TABLET SUBLINGUAL Discontinued — - FENTANYL CITRATEWATSON LABSANDA 07907520115 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.1MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.2MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.4MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.6MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — EQ 0.8MG BASE TABLET BUCCAL, SUBLINGUAL Discontinued — - FENTANYL CITRATEPAR PHARMANDA 07731220096 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.2MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 0.4MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 0.6MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 0.8MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 1.2MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 1.6MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — - FENTANYL CITRATESPECGX LLCANDA 07890720096 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.2MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 0.4MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 0.6MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 0.8MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 1.2MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — EQ 1.6MG BASE TROCHE/LOZENGE TRANSMUCOSAL Discontinued — - DR REDDYSANDA 0749171998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05MG BASE/ML INJECTABLE INJECTION Discontinued — - FENTANYL CITRATEWATSON LABSANDA 0734881992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05MG BASE/ML INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 0727861991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05MG BASE/ML INJECTABLE INJECTION Discontinued — - FENTANYL CITRATEABBOTTANDA 0706361990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05MG BASE/ML INJECTABLE INJECTION Discontinued — - FENTANYL CITRATEABBOTTANDA 0706371990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.05MG BASE/ML INJECTABLE INJECTION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9597288 | in 11 mo | ProductU-767 | |
| 7862833 | in 1 yr 10 mo | Product | |
| 7862832 | in 1 yr 10 mo | Product | |
| 9731869 | in 5 yr 6 mo | Product |
Approval history
FDA approval span
First approval
42 yr 9 mo ago
Most recent approval
3 yr 7 mo ago
Approvals span 1984–2023 across 22 FDA applications.
Brand (NDA) 1045%
Generic (ANDA) 1255%
Fentanyl citrate: 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.
