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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10004700 | More potent and less toxic formulations of epinephrine and methods of medical use |
Aug, 2034
(10 years from now) | Active |
| US10039728 | More potent and less toxic formulations of epinephrine and methods of medical use |
Aug, 2034
(10 years from now) | Active |
| US9283197 | More potent and less toxic formulations of epinephrine and methods of medical use |
Aug, 2034
(10 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.
| 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 |
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 has 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 or infringement 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 | 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
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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 Generics:
Epinephrine is the generic name for the brand Epinephrine. 4 different companies have already filed for the generic of Epinephrine, with Teva Pharms Usa 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 | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/mL | 13 Aug, 2020 | 1 | 15 Aug, 2034 |
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 Labs in 2024.
Market Authorisation 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 |