Adrenalin is a drug owned by Endo Operations Ltd. It is protected by 6 US drug patents filed from 2015 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 21, 2039. Details of Adrenalin'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). | |||
| US9295657 | Epinephrine formulations |
Mar, 2035
(10 years from now) | Active |
| US9119876 | Epinephrine formulations |
Mar, 2035
(10 years from now) | Active |
| US10130592 | Epinephrine formulations |
Mar, 2035
(10 years from now) | Active |
| US11083698 | Epinephrine compositions and containers |
Mar, 2039
(14 years from now) | Active |
| US10653646 | Epinephrine compositions and containers |
Mar, 2039
(14 years from now) | Active |
| US11207280 | Epinephrine compositions and containers |
Mar, 2039
(14 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 Adrenalin's patents.
Latest Legal Activities on Adrenalin's Patents
Given below is the list of recent legal activities going on the following patents of Adrenalin.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Oct, 2023 | US10653646 |
| Email Notification | 06 Mar, 2023 | US11207280 |
| Change in Power of Attorney (May Include Associate POA) | 06 Mar, 2023 | US11207280 |
| Correspondence Address Change | 01 Mar, 2023 | US11207280 |
| Change in Power of Attorney (May Include Associate POA) | 27 Feb, 2023 | US10653646 |
| Email Notification | 27 Feb, 2023 | US10653646 |
| Change in Power of Attorney (May Include Associate POA) | 24 Feb, 2023 | US11083698 |
| Email Notification | 24 Feb, 2023 | US11083698 |
| Correspondence Address Change | 23 Feb, 2023 | US11083698 |
| Correspondence Address Change | 23 Feb, 2023 | US10653646 |
US patents provide insights into the exclusivity only within the United States, but Adrenalin 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 Adrenalin's family patents as well as insights into ongoing legal events on those patents.
Adrenalin's family patents
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Generic Launch
Generic Release Date:
Adrenalin's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 21, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Adrenalin Generics:
Epinephrine is the generic name for the brand Adrenalin. 4 different companies have already filed for the generic of Adrenalin, with Teva Pharms Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Adrenalin's generic
How can I launch a generic of Adrenalin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Adrenalin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Adrenalin'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 Adrenalin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/mL ampules | 09 Mar, 2016 | 1 | 06 Jul, 2018 | 13 Mar, 2035 | Deferred |
| 30 mg/30 mL | 20 Aug, 2018 | 1 | 24 Apr, 2020 | 13 Mar, 2035 | Eligible |
About Adrenalin
Adrenalin is a drug owned by Endo Operations Ltd. It is used for emergency treatment of allergic reactions, including anaphylaxis, and to increase mean arterial blood pressure in adults with hypotension associated with septic shock. Adrenalin uses Epinephrine as an active ingredient. Adrenalin was launched by Endo Operations in 2013.
Market Authorisation Date:
Adrenalin was approved by FDA for market use on 18 December, 2013.
Active Ingredient:
Adrenalin uses Epinephrine as the active ingredient. Check out other Drugs and Companies using Epinephrine ingredient
Treatment:
Adrenalin is used for emergency treatment of allergic reactions, including anaphylaxis, and to increase mean arterial blood pressure in adults with hypotension associated with septic shock.
Dosage:
Adrenalin is available in the following dosage forms - solution form for intravenous use, solution form for intramuscular, intravenous, subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 30MG BASE/30ML (EQ 1MG BASE/ML) | SOLUTION | Prescription | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION | Prescription | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| 4MG/250ML (16MCG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 8MG/250ML (32MCG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 2MG/250ML (8MCG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 10MG/250ML (40MCG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 5MG/250ML (20MCG/ML) | SOLUTION | Prescription | INTRAVENOUS |