Epinephrine Patent Expiration
Epinephrine was first introduced by Sterling Health Div Sterling Winthrop Inc
Epinephrine Patents
Given below is the list of patents protecting Epinephrine, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Adrenaclick | US10166334 | Medicine injection apparatuses | Jan 21, 2025 | Impax |
| Adrenaclick | US10166344 | Injection needle assembly | Jan 21, 2025 | Impax |
| Adrenaclick | US5665071 | Reloadable automatic or manual emergency injection system |
May 27, 2013
(Expired) | Impax |
| Adrenaclick | US7905352 | Kits containing medicine injection devices and containers | Apr 12, 2027 | Impax |
| Adrenalin | US10130592 | Epinephrine formulations | Mar 13, 2035 | Endo Operations |
| Adrenalin | US10653646 | Epinephrine compositions and containers | Mar 21, 2039 | Endo Operations |
| Adrenalin | US11083698 | Epinephrine compositions and containers | Mar 21, 2039 | Endo Operations |
| Adrenalin | US11207280 | Epinephrine compositions and containers | Mar 21, 2039 | Endo Operations |
| Adrenalin | US9119876 | Epinephrine formulations | Mar 13, 2035 | Endo Operations |
| Adrenalin | US9295657 | Epinephrine formulations | Mar 13, 2035 | Endo Operations |
| Auvi-q | US10314977 | Devices, systems and methods for medicament delivery | Nov 23, 2024 | Kaleo Inc |
| Auvi-q | US10335549 | Devices, systems and methods for medicament delivery | Apr 30, 2025 | Kaleo Inc |
| Auvi-q | US10688244 | Medicament delivery device and methods for delivering drugs to infants and children | Dec 21, 2037 | Kaleo Inc |
| Auvi-q | US10737028 | Devices, systems and methods for medicament delivery | Nov 23, 2024 | Kaleo Inc |
| Auvi-q | US10842938 | Medicament delivery device and methods for delivering drugs to infants and children | Dec 21, 2037 | Kaleo Inc |
| Auvi-q | US10960155 | Devices, systems and methods for medicament delivery | Jun 25, 2026 | Kaleo Inc |
| Auvi-q | US11590286 | Devices, systems and methods for medicament delivery | Dec 12, 2026 | Kaleo Inc |
| Auvi-q | US11771830 | Medicament delivery device and methods for delivering drugs to infants and children | Dec 21, 2037 | Kaleo Inc |
| Auvi-q | US7731686 | Devices, systems and methods for medicament delivery | Jun 01, 2026 | Kaleo Inc |
| Auvi-q | US7731690 | Devices, systems and methods for medicament delivery | Jan 15, 2025 | Kaleo Inc |
| Auvi-q | US7749194 | Devices, systems, and methods for medicament delivery | Oct 30, 2028 | Kaleo Inc |
| Auvi-q | US7918823 | Devices, systems and methods for medicament delivery | Nov 23, 2024 | Kaleo Inc |
| Auvi-q | US7947017 | Devices, systems and methods for medicament delivery | Mar 12, 2028 | Kaleo Inc |
| Auvi-q | US8016788 | Devices, systems and methods for medicament delivery | Mar 21, 2025 | Kaleo Inc |
| Auvi-q | US8021344 | Medicament delivery device configured to produce an audible output | Nov 02, 2029 | Kaleo Inc |
| Auvi-q | US8206360 | Devices, systems and methods for medicament delivery | Feb 27, 2027 | Kaleo Inc |
| Auvi-q | US8226610 | Medical injector with compliance tracking and monitoring | Apr 10, 2029 | Kaleo Inc |
| Auvi-q | US8231573 | Medicament delivery device having an electronic circuit system | Nov 25, 2028 | Kaleo Inc |
| Auvi-q | US8313466 | Devices, systems and methods for medicament delivery | Nov 23, 2024 | Kaleo Inc |
| Auvi-q | US8361029 | Devices, systems and methods for medicament delivery | Nov 23, 2024 | Kaleo Inc |
| Auvi-q | US8425462 | Devices, systems, and methods for medicament delivery | Nov 23, 2024 | Kaleo Inc |
| Auvi-q | US8608698 | Devices, systems and methods for medicament delivery | Nov 23, 2024 | Kaleo Inc |
| Auvi-q | US8920377 | Devices, systems and methods for medicament delivery | Nov 23, 2024 | Kaleo Inc |
| Auvi-q | US8926594 | Devices, systems and methods for medicament delivery | Mar 31, 2026 | Kaleo Inc |
| Auvi-q | US9056170 | Devices, systems and methods for medicament delivery | Nov 23, 2024 | Kaleo Inc |
| Auvi-q | US9149579 | Devices, systems and methods for medicament delivery | Jul 19, 2025 | Kaleo Inc |
| Auvi-q | US9238108 | Medicament delivery device having an electronic circuit system | Feb 20, 2027 | Kaleo Inc |
| Auvi-q | US9259539 | Devices, systems and methods for medicament delivery | Feb 01, 2026 | Kaleo Inc |
| Auvi-q | US9278182 | Devices, systems and methods for medicament delivery | Feb 01, 2026 | Kaleo Inc |
| Auvi-q | US9724471 | Devices, systems, and methods for medicament delivery | May 23, 2027 | Kaleo Inc |
| Auvi-q | US9737669 | Devices, systems and methods for medicament delivery | Nov 23, 2024 | Kaleo Inc |
| Auvi-q | US9833573 | Devices, systems and methods for medicament delivery | Nov 23, 2024 | Kaleo Inc |
| Epinephrine | US10004700 | More potent and less toxic formulations of epinephrine and methods of medical use | Aug 14, 2034 | Bpi Labs |
| Epinephrine | US10039728 | More potent and less toxic formulations of epinephrine and methods of medical use | Aug 14, 2034 | Bpi Labs |
| Epinephrine | US9283197 | More potent and less toxic formulations of epinephrine and methods of medical use | Aug 15, 2034 | Bpi Labs |
| Epipen | US7449012 | Automatic injector | Sep 11, 2025 | Mylan Speciality Lp |
| Epipen | US7794432 | Automatic injector with kickback attenuation | Sep 11, 2025 | Mylan Speciality Lp |
| Epipen | US8048035 | Automatic injector with needle cover | Sep 11, 2025 | Mylan Speciality Lp |
| Epipen | US8870827 | Automatic injector | Sep 11, 2025 | Mylan Speciality Lp |
| Epipen | US9586010 | Automatic injector with needle cover | Sep 11, 2025 | Mylan Speciality Lp |
| Epipen Jr. | US7449012 | Automatic injector | Sep 11, 2025 | Mylan Speciality Lp |
| Epipen Jr. | US7794432 | Automatic injector with kickback attenuation | Sep 11, 2025 | Mylan Speciality Lp |
| Epipen Jr. | US8048035 | Automatic injector with needle cover | Sep 11, 2025 | Mylan Speciality Lp |
| Epipen Jr. | US8870827 | Automatic injector | Sep 11, 2025 | Mylan Speciality Lp |
| Epipen Jr. | US9586010 | Automatic injector with needle cover | Sep 11, 2025 | Mylan Speciality Lp |
| Primatene Mist | US8367734 | Stable epinephrine suspension formulation with high inhalation delivery efficiency | Jan 26, 2026 | Armstrong Pharms |
| Symjepi | US11141540 | Syringe devices | Oct 20, 2036 | Adamis Pharms Corp |
| Twinject 0.15 | US7297136 | Medicine injection devices and methods | Jan 18, 2025 | Impax |
| Twinject 0.15 | US7621891 | Method and apparatus for delivering epinephrine | Feb 04, 2025 | Impax |
| Twinject 0.3 | US7297136 | Medicine injection devices and methods | Jan 18, 2025 | Impax |
| Twinject 0.3 | US7621891 | Method and apparatus for delivering epinephrine | Feb 04, 2025 | Impax |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Epinephrine's patents.
Latest Legal Activities on Epinephrine's Patents
Given below is the list recent legal activities going on the following patents of Epinephrine.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 30 Aug, 2023 | US9283197 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 26 Jan, 2022 | US10039728 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 08 Dec, 2021 | US10004700 |
| Patent Issue Date Used in PTA Calculation | 12 Oct, 2021 | US11141540 |
| Recordation of Patent Grant Mailed | 12 Oct, 2021 | US11141540 |
| Email Notification | 23 Sep, 2021 | US11141540 |
| Issue Notification Mailed | 22 Sep, 2021 | US11141540 |
| Application Is Considered Ready for Issue | 14 Sep, 2021 | US11141540 |
| Dispatch to FDC | 14 Sep, 2021 | US11141540 |
| Issue Fee Payment Verified | 10 Sep, 2021 | US11141540 |
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Epinephrine Generics
Several generic applications have been filed for Epinephrine. The first generic version for Epinephrine was by Armstrong Pharmaceuticals Inc and was approved on May 23, 1984. And the latest generic version is by International Medication Systems Ltd and was approved on Apr 24, 2020.
Given below is the list of companies who have filed for Epinephrine generic.
1. INTL MEDICATION SYS
International Medication Systems Ltd has filed for 1 generic for Epinephrine. Given below are the details of the strengths of this generic introduced by Intl Medication Sys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 30MG BASE/30ML (EQ 1MG BASE/ML) | solution | Prescription | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | Apr 24, 2020 |
2. TEVA PHARMS USA
Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Epinephrine. All of these versions come by the name EPINEPHRINE (AUTOINJECTOR). Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.15MG/DELIVERY | injectable | Prescription | INTRAMUSCULAR, SUBCUTANEOUS | AB | Aug 16, 2018 |
| 0.3MG/DELIVERY | injectable | Prescription | INTRAMUSCULAR, SUBCUTANEOUS | AB | Aug 16, 2018 |
3. AM REGENT
American Regent Inc has filed for 1 generic for Epinephrine. Given below are the details of the strengths of this generic introduced by Am Regent.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 1MG BASE/ML (EQ 1MG BASE/ML) | solution | Discontinued | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | N/A | Jul 6, 2018 |
4. ARMSTRONG PHARMS
Armstrong Pharmaceuticals Inc has filed for 1 generic for Epinephrine. Given below are the details of the strengths of this generic introduced by Armstrong Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.2MG/INH | aerosol, metered | Discontinued | INHALATION | N/A | May 23, 1984 |