Epinephrine Patent Expiration

Epinephrine was first introduced by Sterling Health Div Sterling Winthrop Inc in its drug Bronkaid Mist on Approved Prior to Jan 1, 1982. Other drugs containing Epinephrine are Adrenaclick, Epipen Jr., Epipen E Z Pen, Twinject 0.3, Neffy, Epipen, Epi E Z Pen Jr, Auvi-Q, Adrenalin, Primatene Mist, Epinephrine, Twinject 0.15, Sus-Phrine Sulfite Free, Symjepi. 15 different companies have introduced drugs containing Epinephrine.


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
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
Neffy US10682414 Intranasal epinephrine formulations and methods for the treatment of disease Feb 06, 2039 Ars Pharms Operation
Neffy US11191838 Intranasal epinephrine formulations and methods for the treatment of disease Feb 06, 2039 Ars Pharms Operation
Neffy US11717571 Intranasal epinephrine formulations and methods for the treatment of disease Feb 06, 2039 Ars Pharms Operation
Neffy US11744895 Intranasal epinephrine formulations and methods for the treatment of disease Feb 06, 2039 Ars Pharms Operation
Neffy US11918655 Intranasal epinephrine formulations and methods for the treatment of disease Feb 06, 2039 Ars Pharms Operation
Neffy US10576156 Compositions for drug administration Feb 06, 2038 Ars Pharms Operation
Neffy US11173209 Compositions for drug administration Feb 06, 2038 Ars Pharms Operation
Auvi-q US10688244 Medicament delivery device and methods for delivering drugs to infants and children Dec 21, 2037 Kaleo Inc
Auvi-q US10842938 Medicament delivery device and methods for delivering drugs to infants and children Dec 21, 2037 Kaleo Inc
Auvi-q US11771830 Medicament delivery device and methods for delivering drugs to infants and children Dec 21, 2037 Kaleo Inc
Symjepi US11141540 Syringe devices Oct 20, 2036 Adamis Pharms Corp
Adrenalin US10130592 Epinephrine formulations Mar 13, 2035 Endo Operations
Adrenalin US9119876 Epinephrine formulations Mar 13, 2035 Endo Operations
Adrenalin US9295657 Epinephrine formulations Mar 13, 2035 Endo Operations
Epinephrine US9283197 More potent and less toxic formulations of epinephrine and methods of medical use Aug 15, 2034 Bpi Labs
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
Auvi-q US8021344 Medicament delivery device configured to produce an audible output Nov 02, 2029 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 US7749194 Devices, systems, and methods for medicament delivery Oct 30, 2028 Kaleo Inc
Auvi-q US7947017 Devices, systems and methods for medicament delivery Mar 12, 2028 Kaleo Inc
Auvi-q US9724471 Devices, systems, and methods for medicament delivery May 23, 2027 Kaleo Inc
Adrenaclick US7905352 Kits containing medicine injection devices and containers Apr 12, 2027 Impax
Auvi-q US8206360 Devices, systems and methods for medicament delivery Feb 27, 2027 Kaleo Inc
Auvi-q US9238108 Medicament delivery device having an electronic circuit system Feb 20, 2027 Kaleo Inc
Auvi-q US11590286 Devices, systems and methods for medicament delivery Dec 12, 2026 Kaleo Inc
Auvi-q US10960155 Devices, systems and methods for medicament delivery Jun 25, 2026 Kaleo Inc
Auvi-q US7731686 Devices, systems and methods for medicament delivery Jun 01, 2026 Kaleo Inc
Auvi-q US8926594 Devices, systems and methods for medicament delivery Mar 31, 2026 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
Primatene Mist US8367734 Stable epinephrine suspension formulation with high inhalation delivery efficiency Jan 26, 2026 Armstrong Pharms
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
Auvi-q US9149579 Devices, systems and methods for medicament delivery Jul 19, 2025 Kaleo Inc
Auvi-q US10335549 Devices, systems and methods for medicament delivery Apr 30, 2025 Kaleo Inc
Auvi-q US8016788 Devices, systems and methods for medicament delivery Mar 21, 2025 Kaleo Inc
Twinject 0.15 US7621891 Method and apparatus for delivering epinephrine Feb 04, 2025 Impax
Twinject 0.3 US7621891 Method and apparatus for delivering epinephrine Feb 04, 2025 Impax
Adrenaclick US10166334 Medicine injection apparatuses Jan 21, 2025 Impax
Adrenaclick US10166344 Injection needle assembly Jan 21, 2025 Impax
Twinject 0.15 US7297136 Medicine injection devices and methods Jan 18, 2025 Impax
Twinject 0.3 US7297136 Medicine injection devices and methods Jan 18, 2025 Impax
Auvi-q US7731690 Devices, systems and methods for medicament delivery Jan 15, 2025 Kaleo Inc
Auvi-q US10314977 Devices, systems and methods for medicament delivery Nov 23, 2024 Kaleo Inc
Auvi-q US10737028 Devices, systems and methods for medicament delivery Nov 23, 2024 Kaleo Inc
Auvi-q US7918823 Devices, systems and methods for medicament delivery Nov 23, 2024 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 US9056170 Devices, systems and methods for medicament delivery Nov 23, 2024 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
Adrenaclick US5665071 Reloadable automatic or manual emergency injection system May 27, 2013

(Expired)

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.

Given below is the list recent legal activities going on the following patents of Epinephrine.

Activity Date Patent Number
Patent litigations
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


Epinephrine's Family Patents

Family Patents

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Epinephrine Generic API Manufacturers

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 American Regent Inc and was approved on Sep 6, 2024.

Given below is the list of companies who have filed for Epinephrine generic, along with the locations of their manufacturing plants worldwide.


1. AM REGENT

American Regent Inc has filed for 2 different strengths of generic version 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
EQ 30MG BASE/30ML (EQ 1MG BASE/ML)

solution Prescription INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP Sep 6, 2024





2. 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





3. 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





4. 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
0.3MG/DELIVERY

injectable Prescription INTRAMUSCULAR, SUBCUTANEOUS AB Aug 16, 2018
0.15MG/DELIVERY

injectable Prescription INTRAMUSCULAR, SUBCUTANEOUS AB Aug 16, 2018