Treats allergic reactions (Type I) including anaphylaxis. Sold as Sus-Phrine Sulfite Free, Primatene Mist, Bronkaid Mist, Epipen, Epipen Jr. and 9 more. Every FDA application for this active ingredient: 17 branded and 16 generic.
As of Nov 13, 2026, FDA lists 33 applications for Epinephrine (sold as Sus-Phrine Sulfite Free, Primatene Mist, Bronkaid Mist and others), first approved Jun 8, 1951, with 10 new uses approved and 4 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Epinephrine | Part D | $128M | +8% | 476,802 |
| Neffy | Part D | $3.9M | +1738% | 3,910 |
| Auvi-Q | Part D | $3.6M | +402% | 11,964 |
| Adrenalin | Part D | $56K | -8% | 3,118 |
| Epipen 2-Pak | Part D | $43K | -74% | 71 |
| Adrenalin | Part B | $6K | -43% | 1,088 |
| ADRENALIN(J0169) | Part B | $4K | New | 340 |
| Epinephrinesnap-V | Part D | $2K | New | 16 |
| ADRENALIN(J0165) | Part B | $1K | New | 427 |
| EPINEPHRINE | Part B | $0K | New | 48 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jun 8, 1951 | Sus-Phrine Sulfite FreeNDA 7942 · New formulation or manufacturer | Forest Labs | 14 | Discontinued |
| Nov 8, 1967 | Primatene Mist, Bronitin MistNDA 16126 · New formulation or manufacturer | Wyeth Cons | 21 | Discontinued |
| Aug 11, 1969 | Bronkaid MistNDA 16803 · New dosage form | Sterling | 11 | Discontinued |
| May 23, 1984 | EpinephrineANDA 87907 | Armstrong Pharms | 17 | Discontinued |
| Dec 22, 1987 | Epipen, Epipen Jr.NDA 19430 · New formulation or manufacturer | Viatris | 34 | Marketed |
| May 30, 2003 | Twinject, AdrenaclickNDA 20800 · New dosage form | Impax | 20 | Marketed |
| Aug 10, 2012 | Auvi-QNDA 201739 · New formulation or manufacturer | Kaleo Inc | 10 | Marketed |
| Dec 7, 2012 | AdrenalinNDA 204200 · TYPE 7 | Ph Health | 8 | Marketed |
| Dec 18, 2013 | AdrenalinNDA 204640 · TYPE 7 | Ph Health | 7 | Marketed |
| Jul 29, 2014 | EpinephrineNDA 205029 · TYPE 7 | Bpi Labs | 12 | Marketed |
| Jun 15, 2017 | SymjepiNDA 207534 · New formulation or manufacturer | Adamis Pharms Corp | 3 | Marketed |
| Jul 6, 2018 | EpinephrineANDA 207568 | Am Regent | 2 | Discontinued |
| Aug 16, 2018 | EpinephrineANDA 90589 | Teva Pharms USA | 4 | Marketed |
| Nov 7, 2018 | Primatene MistNDA 205920 · New formulation or manufacturer | Armstrong Pharms | 0 | Marketed |
| Nov 5, 2019 | EpinephrineNDA 209359 · TYPE 7 | Hospira | 3 | Discontinued |
| Apr 24, 2020 | EpinephrineANDA 211880 | Intl Medication Sys | 0 | Marketed |
| Aug 15, 2022 | EpinephrineNDA 211363 · TYPE 7 | Intl Medication Sys | 0 | Marketed |
| Apr 21, 2023 | AdrenalinNDA 215875 · New formulation or manufacturer | Ph Health | 1 | Marketed |
| Aug 9, 2024 | NeffyNDA 214697 · New dosage form | Ars Pharms Operation | 4 | Marketed |
| Sep 6, 2024 | EpinephrineANDA 217192 | Am Regent | 0 | Marketed |
| Nov 20, 2024 | EpinephrineANDA 213708 | Fresenius Kabi USA | 0 | Marketed |
| Feb 6, 2025 | EpinephrineANDA 219239 | Gland | 1 | Marketed |
| Mar 13, 2025 | EpinephrineNDA 215425 · New formulation or manufacturer | Fresenius Kabi USA | 0 | Marketed |
| Jun 3, 2025 | EpinephrineANDA 218144 | Gland | 0 | Marketed |
| Oct 14, 2025 | EpinephrineANDA 217485 | Amneal | 0 | Marketed |
| Dec 8, 2025 | EpinephrineANDA 218208 | Amneal | 0 | Marketed |
| Mar 30, 2026 | EpinephrineNDA 220626 · TYPE 4/5 | Baxter Hlthcare Corp | 0 | Marketed |
| May 29, 2026 | EpinephrineANDA 220562 | Hikma | 0 | Marketed |
| Jul 31, 2026 | EpinephrineANDA 217426 | Deva Hlding | 0 | Marketed |
| Sep 14, 2026 | EpinephrineANDA 219832 | Zydus Pharms | 0 | Marketed |
| Sep 15, 2026 | EpinephrineANDA 220657 | Apotex | 0 | Marketed |
| Oct 26, 2026 | EpinephrineANDA 220400 | Gland | 0 | Marketed |
| — | EpinephrineANDA 208908 | Hospira Inc | 0 | Discontinued |
| Letter | Product | Now |
|---|---|---|
| Sep 19, 2023 | NDA 214697Clinical/Clinical Pharmacology, Product Quality, Device | Approved |
| Dec 12, 2018 | NDA 211363Product Quality | Approved |
| Dec 23, 2016 | Primatene Mist (epinephrine inhalation aerosol)Clinical | Approved |
| May 22, 2014 | Epinephrine HFAProduct Quality, Nonclinical, Clinical | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Viatris
Apotex