Generic competition · all medicines · read 12 November 2026
Is there a generic of Epinephrine, and who makes it?
Epinephrine appears in 9 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 generic makers listed as marketed across them. 4 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 5.6 and 30.7 years after the first brand approval. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Epinephrine appears in 9 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 generic makers listed as marketed across them.
- 4 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came between 5.6 and 30.7 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Solution, Intramuscular, Intravenous, Subcutaneous
Four or more generic makers listed
Brand listed as marketed: Adrenalin and Epinephrine. 8 generic makers with 11 generic products listed as marketed; the first generic approval is dated 6 July 2018.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| International Medication Systems Ltd | 24 April 2020 | 1 |
| American Regent Inc | 6 September 2024 | 1 |
| Gland Pharma Ltd | 6 February 2025 | 3 |
| Amneal Eu Ltd | 14 October 2025 | 2 |
| Hikma Pharmaceuticals Usa Inc | 29 May 2026 | 1 |
| Deva Holding Anonim Sirketi | 31 July 2026 | 1 |
| Zydus Pharmaceuticals Usa Inc | 14 September 2026 | 1 |
| Apotex Inc | 15 September 2026 | 1 |
Patents and exclusivities still listed
- 13 March 2035Patent 9295657
- 13 March 2035Patent 9119876 drug product
- 13 March 2035Patent 12280024 drug product
- 13 March 2035Patent 10130592 drug product
- 17 January 2045Patent 12539283 drug product
Injectable, Intramuscular, Subcutaneous
One to three generic makers listed
Brand listed as marketed: Adrenaclick, Epipen and Epipen Jr.. 1 generic maker with 2 generic products listed as marketed; the first generic approval is dated 16 August 2018.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Teva Pharmaceuticals Usa Inc | 16 August 2018 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Intravenous
Brand listed, no generic listed as marketed
Brand listed as marketed: Adrenalin and Epinephrine. No generic is listed as marketed.
Patents and exclusivities still listed
- 21 March 2039Patent 11083698
- 21 March 2039Patent 10653646 drug product
- 21 March 2039Patent 11207280 drug product
- 21 March 2039Patent 12133837 drug product
Solution, Intramuscular, Subcutaneous
Brand listed, no generic listed as marketed
Brand listed as marketed: Auvi-Q and Symjepi. No generic is listed as marketed.
Patents and exclusivities still listed
- 12 December 2026Patent 11590286 drug product
- 27 February 2027Patent 8206360 drug product
- 12 March 2028Patent 7947017 drug product
- 25 November 2028Patent 8231573 drug product
- 10 April 2029Patent 8226610 drug product
- 2 November 2029Patent 8021344 drug product
- 20 October 2036Patent 11141540 drug product
- 21 December 2037Patent 10688244 drug product
2 more patents are listed.
Aerosol, Metered, Inhalation
Brand listed, no generic listed as marketed
Brand listed as marketed: Primatene Mist. No generic is listed as marketed (1 generic product listed as discontinued).
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Intravenous, Intraocular, Intramuscular, Subcutaneous
One to three generic makers listed
Brand listed as marketed: Epinephrine. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 20 November 2024.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Fresenius Kabi Usa Llc | 20 November 2024 | 1 |
| Gland Pharma Ltd | 3 June 2025 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Injectable, Injection
Nothing listed as marketed
Every brand product here is listed as discontinued. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Injectable, Intramuscular
Nothing listed as marketed
Every brand product here is listed as discontinued. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Spray, Nasal
Brand listed, no generic listed as marketed
Brand listed as marketed: Neffy. No generic is listed as marketed.
Patents and exclusivities still listed
- 6 February 2038Patent 11173209
- 6 February 2038Patent 10576156 drug product
- 6 February 2039Patent 11918655
- 6 February 2039Patent 11744895
- 6 February 2039Patent 11717571
- 6 February 2039Patent 11191838 drug product
- 6 February 2039Patent 10682414
- 6 February 2039Patent 12324838 drug product
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.