FDA Orange Book · active-ingredient family
Epinephrine
Epinephrine is approved as 17 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EPINEPHRINE · NDA 220626
17
Brand (NDA)
11
Generics (ANDA)
28
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, metered, injectable, solution, spray
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPINEPHRINERLD×2 | BAXTER HLTHCARE CORP | NDA 220626 | — | Mar 30, 2026 | |
| EPINEPHRINERLD | FRESENIUS KABI USA | NDA 215425 | — | Mar 13, 2025 | |
| NEFFYRLD×2 | ARS PHARMS OPERATION | NDA 214697 | — | Mar 05, 2025 | |
| EPINEPHRINERLD×5 | BPI LABS | NDA 205029 | AP | Mar 04, 2024 | |
| ADRENALINRLD×5 | PH HEALTH | NDA 215875 | — | Apr 21, 2023 | |
| EPINEPHRINERLD | INTL MEDICATION SYS | NDA 211363 | — | Aug 15, 2022 | |
| EPINEPHRINERLD | HOSPIRA | NDA 209359 | — | Nov 05, 2019 | |
| PRIMATENE MISTRLD | ARMSTRONG PHARMS | NDA 205920 | — | Nov 07, 2018 | |
| SYMJEPIRLD×2 | ADAMIS PHARMS CORP | NDA 207534 | — | Sep 27, 2018 | |
| AUVI-QRLD×3 | KALEO INC | NDA 201739 | — | Nov 17, 2017 | |
| ADRENALINRLD | PH HEALTH | NDA 204640 | AP | Dec 18, 2013 | |
| ADRENALINRLD | PH HEALTH | NDA 204200 | AP | Dec 07, 2012 | |
| ADRENACLICKRLD×4 | IMPAX | NDA 020800 | BX | Nov 25, 2009 | |
| EPIPENRLD×4 | VIATRIS | NDA 019430 | AB | Dec 22, 1987 | |
| SUS-PHRINE SULFITE FREE×2 | FOREST LABS | NDA 007942 | — | Feb 05, 1999 | |
| BRONKAID MIST | STERLING | NDA 016803 | — | Approved Prior to Jan 1, 1982 | |
| PRIMATENE MIST | WYETH CONS | NDA 016126 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPINEPHRINE | HIKMA | ANDA 220562 | AP | May 29, 2026 | |
| EPINEPHRINE | AMNEAL | ANDA 218208 | AP | Dec 08, 2025 | |
| EPINEPHRINE | AMNEAL | ANDA 217485 | AP | Oct 14, 2025 | |
| EPINEPHRINE | GLAND | ANDA 218144 | AP | Jun 03, 2025 | |
| EPINEPHRINE×2 | GLAND | ANDA 219239 | AP | Feb 06, 2025 | |
| EPINEPHRINE | FRESENIUS KABI USA | ANDA 213708 | AP | Nov 20, 2024 | |
| EPINEPHRINE | AM REGENT | ANDA 217192 | AP | Sep 06, 2024 | |
| EPINEPHRINE | INTL MEDICATION SYS | ANDA 211880 | AP | Apr 24, 2020 | |
| EPINEPHRINE (AUTOINJECTOR)×2 | TEVA PHARMS USA | ANDA 090589 | AB | Aug 16, 2018 | |
| EPINEPHRINE | AM REGENT | ANDA 207568 | — | Jul 06, 2018 | |
| EPINEPHRINE | ARMSTRONG PHARMS | ANDA 087907 | — | May 23, 1984 |
Listed patents (28)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8367734 | Jan 26, 2026 | 5 mo ago | Product |
| 11590286 | Dec 12, 2026 | in 6 mo | Product |
| 8206360 | Feb 27, 2027 | in 8 mo | Product |
| 7947017 | Mar 12, 2028 | in 1 yr 9 mo | Product |
| 8231573 | Nov 25, 2028 | in 2 yr 6 mo | Product |
| 8226610 | Apr 10, 2029 | in 2 yr 10 mo | Product |
| 8021344 | Nov 02, 2029 | in 3 yr 5 mo | Product |
| 9295657 | Mar 13, 2035 | in 8 yr 10 mo | U-1829 |
| 9119876 | Mar 13, 2035 | in 8 yr 10 mo | Product |
| 12280024 | Mar 13, 2035 | in 8 yr 10 mo | Product |
| 10130592 | Mar 13, 2035 | in 8 yr 10 mo | Product |
| 11141540 | Oct 20, 2036 | in 10 yr 6 mo | ProductU-3379 |
| 10688244 | Dec 21, 2037 | in 11 yr 8 mo | ProductU-2980 |
| 10842938 | Dec 21, 2037 | in 11 yr 8 mo | ProductU-2980 |
| 11771830 | Dec 21, 2037 | in 11 yr 8 mo | ProductU-2980 |
| 11173209 | Feb 06, 2038 | in 11 yr 10 mo | U-3979 |
| 10576156 | Feb 06, 2038 | in 11 yr 10 mo | Product |
| 11918655 | Feb 06, 2039 | in 12 yr 10 mo | U-3979 |
| 11744895 | Feb 06, 2039 | in 12 yr 10 mo | U-3979 |
| 11717571 | Feb 06, 2039 | in 12 yr 10 mo | U-3979 |
| 11191838 | Feb 06, 2039 | in 12 yr 10 mo | ProductU-3979 |
| 10682414 | Feb 06, 2039 | in 12 yr 10 mo | U-3979 |
| 12324838 | Feb 06, 2039 | in 12 yr 10 mo | Product |
| 11083698 | Mar 21, 2039 | in 12 yr 11 mo | U-3567 |
| 10653646 | Mar 21, 2039 | in 12 yr 11 mo | Product |
| 11207280 | Mar 21, 2039 | in 12 yr 11 mo | Product |
| 12133837 | Mar 21, 2039 | in 12 yr 11 mo | Product |
| 12539283 | Jan 17, 2045 | in 18 yr 10 mo | Product |
Epinephrine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
