ADRENALIN Drug Patent Profile
✉ Email this page to a colleague
When do Adrenalin patents expire, and what generic alternatives are available?
Adrenalin is a drug marketed by Par Sterile Products 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.
Summary for ADRENALIN
International Patents: | 9 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 88 |
Clinical Trials: | 44 |
Patent Applications: | 3,844 |
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 |
Recent Clinical Trials for ADRENALIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Constant Therapeutics LLC | Phase 2 |
Rambam Health Care Campus | Phase 2 |
Tomsk National Research Medical Center of the Russian Academy of Sciences | N/A |
Pharmacology for ADRENALIN
Drug Class | Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ADRENALIN
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Epinephrine compositions and containers
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Epinephrine compositions and containers
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TO INCREASE MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
Epinephrine compositions and containers
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Epinephrine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Epinephrine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204200-001 | Dec 7, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAVENOUS | 215875-005 | Apr 21, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAVENOUS | 215875-001 | Apr 21, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204640-001 | Dec 18, 2013 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAVENOUS | 215875-003 | Apr 21, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAVENOUS | 215875-005 | Apr 21, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 |
---|---|---|---|
China | 107614017 | 肾上腺素制剂 (EPINEPHRINE FORMULATIONS) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2019183416 | ⤷ Try a Trial | |
Canada | 2978464 | FORMULATIONS D'EPINEPHRINE (EPINEPHRINE FORMULATIONS) | ⤷ Try a Trial |
Canada | 3093725 | COMPOSITIONS ET RECIPIENTS D'EPINEPHRINE (EPINEPHRINE COMPOSITIONS AND CONTAINERS) | ⤷ Try a Trial |
European Patent Office | 3268045 | FORMULATIONS D'ÉPINÉPHRINE (EPINEPHRINE FORMULATIONS) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2016149028 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |