EPINEPHRINE - Generic Drug Details
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What are the generic drug sources for epinephrine and what is the scope of freedom to operate?
Epinephrine
is the generic ingredient in thirty-three branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Mylan Speciality Lp, Impax, Teva Pharms Usa, Par Sterile Products, Am Regent, Bpi Labs, Intl Medication Sys, Kaleo Inc, Adamis Pharms Corp, Hospira, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Carlisle, B Braun Medical Inc, Belmora Llc, Eastman Kodak, West-ward Pharms Int, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Fresenius Kabi Usa, Vyteris, Iomed, and Empi, and is included in sixty NDAs. There are thirty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Epinephrine has two hundred patent family members in twenty-four countries.
There are twenty-one drug master file entries for epinephrine. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for EPINEPHRINE
International Patents: | 200 |
US Patents: | 34 |
Tradenames: | 33 |
Applicants: | 35 |
NDAs: | 60 |
Drug Master File Entries: | 21 |
Finished Product Suppliers / Packagers: | 21 |
Raw Ingredient (Bulk) Api Vendors: | 88 |
Clinical Trials: | 692 |
Patent Applications: | 7,000 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for EPINEPHRINE |
Drug Sales Revenues: | Drug sales revenues for EPINEPHRINE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPINEPHRINE |
What excipients (inactive ingredients) are in EPINEPHRINE? | EPINEPHRINE excipients list |
DailyMed Link: | EPINEPHRINE at DailyMed |
Recent Clinical Trials for EPINEPHRINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Hospital "Sestre Milosrdnice" | N/A |
University of Alberta | Phase 1 |
Lawson Health Research Institute | N/A |
Generic filers with tentative approvals for EPINEPHRINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for EPINEPHRINE
Drug Class | Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for EPINEPHRINE
Paragraph IV (Patent) Challenges for EPINEPHRINE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EPINEPHRINE | Injection | epinephrine | 1 mg/mL | 205029 | 1 | 2020-08-13 |
ADRENALIN | Injection | epinephrine | 30 mg/30 mL | 204640 | 1 | 2018-08-20 |
ADRENALIN | Injection | epinephrine | 1 mg/mL ampules | 204200 | 1 | 2016-03-09 |
EPIPEN JR. | Injection (Auto- injector) | epinephrine | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | 019430 | 1 | 2009-07-20 |
US Patents and Regulatory Information for EPINEPHRINE
Expired US Patents for EPINEPHRINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Impax | ADRENACLICK | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-003 | Nov 25, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Impax | ADRENACLICK | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-004 | Nov 25, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPINEPHRINE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 555256 | Housing, typically similar to credit card size, with compressed gas container, medicament container(s) for user to inject medicament | ⤷ Try a Trial |
Canada | 2724069 | DISPOSITIF DE DISTRIBUTION DE MEDICAMENT COMPRENANT UN SYSTEME DE CIRCUIT ELECTRONIQUE (MEDICAMENT DELIVERY DEVICE HAVING AN ELECTRONIC CIRCUIT SYSTEM) | ⤷ Try a Trial |
Australia | 2004325202 | Devices, systems, and methods for medicament delivery | ⤷ Try a Trial |
China | 107614017 | 肾上腺素制剂 (EPINEPHRINE FORMULATIONS) | ⤷ Try a Trial |
Spain | 2481366 | ⤷ Try a Trial | |
United Kingdom | 0910105 | ⤷ Try a Trial | |
United Kingdom | 0822532 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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