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 Par Sterile Products and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.
This drug has seven patent family members in seven countries.
The generic ingredient in ADRENALIN is epinephrine. There are twenty-one drug master file entries for this compound. Seventeen 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 BELCHER on July 29th, 2014.
Summary for ADRENALIN
International Patents: | 7 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 77 |
Clinical Trials: | 44 |
Patent Applications: | 4,531 |
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 |
---|---|
Rambam Health Care Campus | Phase 2 |
Constant Therapeutics LLC | Phase 2 |
Tomsk National Research Medical Center of the Russian Academy of Sciences | N/A |
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 three US patents.
Patents protecting ADRENALIN
Epinephrine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Epinephrine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Epinephrine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204640-001 | Dec 18, 2013 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204200-001 | Dec 7, 2012 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 |
---|---|---|---|
European Patent Office | 3268045 | FORMULATIONS D'ÉPINÉPHRINE (EPINEPHRINE FORMULATIONS) | See Plans and Pricing |
Australia | 2016233682 | Epinephrine formulations | See Plans and Pricing |
Japan | 2018507915 | エピネフリン製剤 | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |