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ADRENALIN Drug Profile
» See Plans and Pricing
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. Sixteen 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: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 77 |
| Clinical Trials: | 36 |
| Patent Applications: | 4,482 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ADRENALIN |
| Drug Sales Revenues: | Drug sales revenues 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 |
|---|---|
| Tomsk National Research Medical Center of the Russian Academy of Sciences | N/A |
| Institute of Liver and Biliary Sciences, India | N/A |
| Stanford University | Early Phase 1 |
Pharmacology for ADRENALIN
| Drug Class | alpha-Adrenergic Agonist beta-Adrenergic Agonist Catecholamine |
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Paragraph IV (Patent) Challenges for ADRENALIN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ADRENALIN | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | epinephrine | 204640 | 2018-08-20 |
| ADRENALIN | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | epinephrine | 204200 | 2016-03-09 |
US Patents and Regulatory Information for ADRENALIN
| 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 | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204640-001 | Dec 18, 2013 | AP | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | ||
| Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204200-001 | Dec 7, 2012 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204640-001 | Dec 18, 2013 | AP | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Get Started for $10 | |||
| Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204640-001 | Dec 18, 2013 | AP | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | ||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2016233682 | Get Started for $10 |
| World Intellectual Property Organization (WIPO) | 2016149028 | Get Started for $10 |
| China | 107614017 | Get Started for $10 |
| Japan | 2018507915 | Get Started for $10 |
| European Patent Office | 3268045 | Get Started for $10 |
| South Korea | 20180034307 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
