Epinephrine - Generic Drug Details
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What are the generic sources for epinephrine and what is the scope of patent protection?
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 fifty-nine NDAs. There are forty-seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Epinephrine has two hundred and thirty-nine patent family members in twenty-six countries.
There are twenty-one drug master file entries for epinephrine. Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for epinephrine
International Patents: | 239 |
US Patents: | 47 |
Tradenames: | 33 |
Applicants: | 35 |
NDAs: | 59 |
Drug Master File Entries: | 21 |
Finished Product Suppliers / Packagers: | 25 |
Raw Ingredient (Bulk) Api Vendors: | 88 |
Clinical Trials: | 683 |
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 of Alberta | Phase 1 |
Benha University | Phase 3 |
Hospital de San Carlos Dr. Benicio Arzola Medina | Phase 4 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-002 | Aug 10, 2012 | BX | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-001 | Aug 10, 2012 | BX | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Impax | ADRENACLICK | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-003 | Nov 25, 2009 | BX | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
>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 | ⤷ 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 |
---|---|---|---|
Japan | 2009090140 | AUTOMATIC SYRINGE | ⤷ Try a Trial |
Canada | 2644547 | APPAREILS, SYSTEMES ET METHODES POUR ADMINISTRATION D'UN MEDICAMENT (DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY) | ⤷ Try a Trial |
South Africa | 201800998 | SYRINGE DEVICES | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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