FDA Orange Book · active-ingredient family
Fentanyl citrate
Fentanyl citrate is approved as 10 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FENTANYL CITRATE · NDA 215870
10
Brand (NDA)
12
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · film, injectable, solution, spray, metered, tablet, troche/lozenge
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FENTANYL CITRATERLD×2 | EXELA PHARMA | NDA 215870 | — | Feb 08, 2023 | |
| FENTANYL CITRATERLD×2 | HIKMA | NDA 019101 | — | Jan 20, 2023 | |
| LAZANDARLD×3 | BTCP PHARMA | NDA 022569 | — | Jun 30, 2011 | |
| ABSTRALRLD×6 | SENTYNL THERAPS INC | NDA 022510 | — | Jan 07, 2011 | |
| FENTORARLD×6 | CEPHALON | NDA 021947 | — | Sep 25, 2006 | |
| ACTIQRLD×6 | CEPHALON | NDA 020747 | — | Nov 04, 1998 | |
| SUBLIMAZE PRESERVATIVE FREERLD | RISING | NDA 016619 | AP | Approved Prior to Jan 1, 1982 | |
| ONSOLIS×5 | ADALVO | NDA 022266 | — | Jul 16, 2009 | |
| FENTANYL×4 | CEPHALON | NDA 020195 | — | Oct 30, 1995 | |
| FENTANYL CITRATE | HOSPIRA | NDA 019115 | AP | Jan 12, 1985 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FENTANYL CITRATE×6 | DR REDDYS LABS SA | ANDA 206329 | — | Aug 22, 2022 | |
| FENTANYL CITRATE | FRESENIUS KABI USA | ANDA 212086 | AP | Sep 01, 2020 | |
| FENTANYL CITRATE PRESERVATIVE FREE | FRESENIUS KABI USA | ANDA 210762 | AP | May 03, 2019 | |
| FENTANYL CITRATE×6 | ACTAVIS LABS FL INC | ANDA 207338 | — | Nov 17, 2017 | |
| FENTANYL CITRATE×5 | WATSON LABS | ANDA 079075 | — | Jan 07, 2011 | |
| FENTANYL CITRATE×6 | PAR PHARM | ANDA 077312 | — | Oct 30, 2009 | |
| FENTANYL CITRATE×6 | SPECGX LLC | ANDA 078907 | — | Oct 30, 2009 | |
| FENTANYL CITRATE PRESERVATIVE FREE | DR REDDYS | ANDA 074917 | — | Feb 03, 1998 | |
| FENTANYL CITRATE | WATSON LABS | ANDA 073488 | — | Jun 30, 1992 | |
| FENTANYL CITRATE PRESERVATIVE FREE | HOSPIRA | ANDA 072786 | — | Sep 24, 1991 | |
| FENTANYL CITRATE | ABBOTT | ANDA 070636 | — | Apr 30, 1990 | |
| FENTANYL CITRATE | ABBOTT | ANDA 070637 | — | Apr 30, 1990 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9597288 | Jul 23, 2027 | in 1 yr 1 mo | ProductU-767 |
| 7862833 | Jun 15, 2028 | in 2 yr | Product |
| 7862832 | Jun 15, 2028 | in 2 yr | Product |
| 9731869 | Jan 26, 2032 | in 5 yr 8 mo | Product |
Fentanyl citrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
