Epinephrine is a drug owned by Fresenius Kabi Usa Llc. It is protected by 1 US drug patent filed in 2026 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 17, 2045. Details of Epinephrine's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12539283 | NA |
Jan, 2045
(18 years from now) | Active |
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 of recent legal activities going on the following patents of Epinephrine.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed | 10 Feb, 2026 | US12539283 |
| Mail Patent eGrant Notification | 03 Feb, 2026 | US12539283 |
| Email Notification | 03 Feb, 2026 | US12539283 |
| Recordation of Patent eGrant | 03 Feb, 2026 | US12539283 |
| Patent Issue Date Used in PTA Calculation | 03 Feb, 2026 | US12539283 |
| Patent eGrant Notification | 03 Feb, 2026 | US12539283 |
| Email Notification | 22 Jan, 2026 | US12539283 |
| Issue Notification Mailed | 21 Jan, 2026 | US12539283 |
| Dispatch to FDC | 12 Jan, 2026 | US12539283 |
| Email Notification | 07 Jan, 2026 | US12539283 |
US patents provide insights into the exclusivity only within the United States, but
Epinephrine is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Epinephrine's family patents as well as insights into
ongoing legal events
on those patents.
Epinephrine's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Epinephrine:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Epinephrine's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 17, 2045 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Epinephrine Generic API suppliers:
Epinephrine is the generic name for the brand Epinephrine. 9 different companies have already filed for the generic of Epinephrine, with Gland having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Epinephrine's generic
How can I launch a generic of Epinephrine before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Epinephrine's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Epinephrine's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Epinephrine -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 13 Aug, 2020 | 15 Aug, 2034 | Non-Forfeiture Deferred | 20 Nov, 2024 | Less |
Alternative Brands for Epinephrine
Epinephrine which is used for emergency treatment of severe allergic reactions (type 1), including anaphylaxis, induction of mydriasis for intraocular surgery, and increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock., has several other brand drugs using the same active ingredient (Epinephrine). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Adamis Pharms Corp |
| ||
| Armstrong Pharms |
| ||
| Ars Pharms Operation |
| ||
| Baxter Hlthcare Corp |
| ||
| Impax |
| ||
| Inforlife |
| ||
| Kaleo Inc |
| ||
| Long Grove Pharms |
| ||
| Ph Health |
| ||
| Viatris |
| ||
| Vyteris |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Epinephrine, Epinephrine's active ingredient. Check the complete list of approved generic manufacturers for Epinephrine
About Epinephrine
Epinephrine is a drug owned by Fresenius Kabi Usa Llc. It is used for emergency treatment of severe allergic reactions (type 1), including anaphylaxis, induction of mydriasis for intraocular surgery, and increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock. Epinephrine uses Epinephrine as an active ingredient. Epinephrine was launched by Fresenius Kabi in 2025.
Approval Date:
Epinephrine was approved by FDA for market use on 13 March, 2025.
Active Ingredient:
Epinephrine uses Epinephrine as the active ingredient. Check out other Drugs and Companies using Epinephrine ingredient
Treatment:
Epinephrine is used for emergency treatment of severe allergic reactions (type 1), including anaphylaxis, induction of mydriasis for intraocular surgery, and increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Dosage:
Epinephrine is available in solution form for intramuscular, intravenous, subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 30MG/30ML (1MG/ML) | SOLUTION | Prescription | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
Epinephrine is a drug owned by Bpi Labs Llc. It is protected by 3 US drug patents filed from 2016 to 2018 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 15, 2034. Details of Epinephrine's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9283197 | More potent and less toxic formulations of epinephrine and methods of medical use |
Aug, 2034
(7 years from now) | Active |
| US10004700 | More potent and less toxic formulations of epinephrine and methods of medical use |
Aug, 2034
(7 years from now) | Active |
| US10039728 | More potent and less toxic formulations of epinephrine and methods of medical use |
Aug, 2034
(7 years from now) | Active |
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 of recent legal activities going on the following patents of Epinephrine.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Recordation of Patent Grant Mailed | 10 Feb, 2026 | US12539283 |
| Mail Patent eGrant Notification | 03 Feb, 2026 | US12539283 |
| Email Notification | 03 Feb, 2026 | US12539283 |
| Recordation of Patent eGrant | 03 Feb, 2026 | US12539283 |
| Patent Issue Date Used in PTA Calculation | 03 Feb, 2026 | US12539283 |
| Patent eGrant Notification | 03 Feb, 2026 | US12539283 |
| Email Notification | 22 Jan, 2026 | US12539283 |
| Issue Notification Mailed | 21 Jan, 2026 | US12539283 |
| Dispatch to FDC | 12 Jan, 2026 | US12539283 |
| Email Notification | 07 Jan, 2026 | US12539283 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Epinephrine and ongoing
litigations to
help you estimate the early arrival of Epinephrine generic.
Epinephrine's Litigations
Epinephrine been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 26, 2019, against patent number US9283197. The petitioner Adamis Pharmaceuticals Corporation, challenged the validity of this patent, with Belcher Pharmaceuticals, LLC as the respondent. Click below to track the latest information on how companies are challenging Epinephrine's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9283197 | April, 2019 |
Terminated-Settled
(02 Aug, 2019) | Belcher Pharmaceuticals, LLC | Adamis Pharmaceuticals Corporation |
US patents provide insights into the exclusivity only within the United States, but
Epinephrine is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Epinephrine's family patents as well as insights into
ongoing legal events
on those patents.
Epinephrine's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Epinephrine:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Epinephrine's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 15, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Epinephrine Generic API suppliers:
Epinephrine is the generic name for the brand Epinephrine. 9 different companies have already filed for the generic of Epinephrine, with Gland having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Epinephrine's generic
How can I launch a generic of Epinephrine before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Epinephrine's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Epinephrine's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Epinephrine -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 13 Aug, 2020 | 15 Aug, 2034 | Non-Forfeiture Deferred | 20 Nov, 2024 | Less |
Alternative Brands for Epinephrine
Epinephrine which is used for emergency treatment of severe allergic reactions (type 1), including anaphylaxis, induction of mydriasis for intraocular surgery, and increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock., has several other brand drugs using the same active ingredient (Epinephrine). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Adamis Pharms Corp |
| ||
| Armstrong Pharms |
| ||
| Ars Pharms Operation |
| ||
| Baxter Hlthcare Corp |
| ||
| Impax |
| ||
| Inforlife |
| ||
| Kaleo Inc |
| ||
| Long Grove Pharms |
| ||
| Ph Health |
| ||
| Viatris |
| ||
| Vyteris |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Epinephrine, Epinephrine's active ingredient. Check the complete list of approved generic manufacturers for Epinephrine
About Epinephrine
Epinephrine is a drug owned by Bpi Labs Llc. It is used for emergency treatment of severe allergic reactions (type 1), including anaphylaxis, induction of mydriasis for intraocular surgery, and increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock. Epinephrine uses Epinephrine as an active ingredient. Epinephrine was launched by Bpi in 2024.
Approval Date:
Epinephrine was approved by FDA for market use on 04 March, 2024.
Active Ingredient:
Epinephrine uses Epinephrine as the active ingredient. Check out other Drugs and Companies using Epinephrine ingredient
Treatment:
Epinephrine is used for emergency treatment of severe allergic reactions (type 1), including anaphylaxis, induction of mydriasis for intraocular surgery, and increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Dosage:
Epinephrine is available in solution form for intravenous, intraocular, intramuscular, subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG/ML (1MG/ML) | SOLUTION | Prescription | INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS |