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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 one Paragraph IV challenge.
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.
US ANDA 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 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 72 |
| Clinical Trials: | 34 |
| Patent Applications: | 4,487 |
| 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 |
| DailyMed Link: | ADRENALIN at DailyMed |
Recent Clinical Trials for ADRENALIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Stanford University | Early Phase 1 |
| Assiut University | Phase 2 |
| Cairo University | Phase 1/Phase 2 |
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 | Start Trial | Start Trial | Start Trial | ||||
| Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204640-001 | Dec 18, 2013 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204200-001 | Dec 7, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204640-001 | Dec 18, 2013 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Par Sterile Products | ADRENALIN | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 204640-001 | Dec 18, 2013 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2018507915 | Start Trial |
| Australia | 2016233682 | Start Trial |
| South Korea | 20180034307 | Start Trial |
| European Patent Office | 3268045 | Start Trial |
| China | 107614017 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2016149028 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
