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, Endo Operations, 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: | 714 |
Patent Applications: | 6,519 |
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 |
---|---|
Montefiore Medical Center | N/A |
University Hospital "Sestre Milosrdnice" | N/A |
Jessyka Lighthall | Phase 3 |
Generic filers with tentative approvals for EPINEPHRINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 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
Anatomical Therapeutic Chemical (ATC) Classes 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Deproco | LIGNOSPAN FORTE | epinephrine bitartrate; lidocaine hydrochloride | INJECTABLE;INJECTION | 088389-001 | Jan 22, 1985 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-002 | Aug 10, 2012 | BX | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Hospira | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | epinephrine; lidocaine hydrochloride | INJECTABLE;INJECTION | 089645-001 | Jun 21, 1988 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dell Labs | LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE | epinephrine; lidocaine hydrochloride | INJECTABLE;INJECTION | 083389-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca | DURANEST | epinephrine bitartrate; etidocaine hydrochloride | INJECTABLE;INJECTION | 017751-007 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-001 | Aug 10, 2012 | BX | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-001 | Aug 10, 2012 | BX | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Sign Up | ⤷ Sign Up |
Impax | ADRENACLICK | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-004 | Nov 25, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPINEPHRINE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 2204201 | ⤷ Sign Up | |
China | 101111281 | Devices, systems, and methods for medicament delivery | ⤷ Sign Up |
Israel | 183247 | DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY | ⤷ Sign Up |
Japan | 4960252 | ⤷ Sign Up | |
Canada | 3199034 | DISPOSITIFS DE TYPE SERINGUE (SYRINGE DEVICES) | ⤷ Sign Up |
Portugal | 3341056 | ⤷ Sign Up | |
Spain | 2926913 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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