ADRENALIN Drug Patent Profile
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When do Adrenalin patents expire, and what generic alternatives are available?
Adrenalin is a drug marketed by Endo Operations and is included in three NDAs. There are six patents protecting this drug and two Paragraph IV challenges.
This drug has nine patent family members in seven countries.
The generic ingredient in ADRENALIN is epinephrine. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Adrenalin
A generic version of ADRENALIN was approved as epinephrine by BPI LABS on July 29th, 2014.
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Questions you can ask:
- What is the 5 year forecast for ADRENALIN?
- What are the global sales for ADRENALIN?
- What is Average Wholesale Price for ADRENALIN?
Summary for ADRENALIN
International Patents: | 9 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 45 |
Patent Applications: | 3,095 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ADRENALIN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADRENALIN |
What excipients (inactive ingredients) are in ADRENALIN? | ADRENALIN excipients list |
DailyMed Link: | ADRENALIN at DailyMed |
![ADRENALIN drug patent expirations Drug patent expirations by year for ADRENALIN](/p/graph/s/t/ADRENALIN-patent-expirations.png)
![Drug Prices for ADRENALIN](/p/graph/drug-price/ADRENALIN.png)
![Drug Sales Revenue Trends for ADRENALIN](/p/graph/drug-sales-revenues/ADRENALIN.png)
Recent Clinical Trials for ADRENALIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The Second Affiliated Hospital of Harbin Medical University | Early Phase 1 |
The First Affiliated Hospital of Nanchang University | Early Phase 1 |
China-Japan Friendship Hospital | Early Phase 1 |
Pharmacology for ADRENALIN
Drug Class | Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Paragraph IV (Patent) Challenges for ADRENALIN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ADRENALIN | Injection | epinephrine | 30 mg/30 mL | 204640 | 1 | 2018-08-20 |
ADRENALIN | Injection | epinephrine | 1 mg/mL ampules | 204200 | 1 | 2016-03-09 |
US Patents and Regulatory Information for ADRENALIN
ADRENALIN is protected by six US patents.
Patents protecting ADRENALIN
Epinephrine formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Epinephrine compositions and containers
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Epinephrine compositions and containers
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TO INCREASE MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
Epinephrine compositions and containers
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Epinephrine formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Epinephrine formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Endo Operations | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204200-001 | Dec 7, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Endo Operations | ADRENALIN | epinephrine | SOLUTION;INTRAVENOUS | 215875-005 | Apr 21, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Endo Operations | ADRENALIN | epinephrine | SOLUTION;INTRAVENOUS | 215875-001 | Apr 21, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Endo Operations | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204640-001 | Dec 18, 2013 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Endo Operations | ADRENALIN | epinephrine | SOLUTION;INTRAVENOUS | 215875-003 | Apr 21, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ADRENALIN
See the table below for patents covering ADRENALIN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2978464 | FORMULATIONS D'EPINEPHRINE (EPINEPHRINE FORMULATIONS) | ⤷ Sign Up |
China | 107614017 | 肾上腺素制剂 (EPINEPHRINE FORMULATIONS) | ⤷ Sign Up |
South Korea | 20180034307 | 에피네프린 제형 | ⤷ Sign Up |
Canada | 3093725 | COMPOSITIONS ET RECIPIENTS D'EPINEPHRINE (EPINEPHRINE COMPOSITIONS AND CONTAINERS) | ⤷ Sign Up |
Japan | 2018507915 | エピネフリン製剤 | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |