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-five branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Viatris, Impax, Teva Pharms Usa, Ph Health, Am Regent, Amneal, Baxter Hlthcare Corp, Bpi Labs, Fresenius Kabi Usa, Gland, Intl Medication Sys, Kaleo Inc, Adamis Pharms Corp, Hospira, Ars Pharms Operation, 3M, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Carlisle, B Braun Medical, Belmora Llc, Eastman Kodak, West-ward Pharms Int, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Vyteris, Iomed, and Empi, and is included in seventy-one NDAs. There are twenty-eight 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-seven patent family members in thirty-four countries.
There are twenty-one drug master file entries for epinephrine. Thirty-two suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for epinephrine
| International Patents: | 237 |
| US Patents: | 28 |
| Tradenames: | 35 |
| Applicants: | 39 |
| NDAs: | 71 |
| Drug Master File Entries: | 21 |
| Finished Product Suppliers / Packagers: | 32 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 824 |
| 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 California, San Francisco | PHASE2 |
| Hospital del Trabajador de Santiago | NA |
| Goldman, Butterwick, Fitzpatrick and Groff | PHASE4 |
Generic filers with tentative approvals for EPINEPHRINE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| ⤷ Start Trial | ⤷ Start Trial | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION;INTRAVENOUS |
| ⤷ Start Trial | ⤷ Start Trial | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION;INTRAVENOUS |
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 |
|---|---|---|---|---|---|---|
| NEFFY | Nasal Spray | epinephrine | 1 mg/spray | 214697 | 1 | 2025-12-29 |
| NEFFY | Nasal Spray | epinephrine | 2 mg/spray | 214697 | 1 | 2025-06-30 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira | LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | epinephrine; lidocaine hydrochloride | INJECTABLE;INJECTION | 078772-001 | May 12, 2008 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bel Mar | PROCAINE HYDROCHLORIDE W/ EPINEPHRINE | epinephrine; procaine hydrochloride | INJECTABLE;INJECTION | 080759-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-003 | Nov 17, 2017 | RX | Yes | No | ⤷ 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 |
Expired US Patents for epinephrine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-003 | Nov 17, 2017 | ⤷ Start Trial | ⤷ Start Trial |
| Impax | TWINJECT | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-001 | May 30, 2003 | ⤷ Start Trial | ⤷ Start Trial |
| Viatris | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for epinephrine
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 257642 | התקנים מסוג מזרק (Syringe devices) | ⤷ Start Trial |
| Eurasian Patent Organization | 202091615 | ⤷ Start Trial | |
| European Patent Office | 3678649 | FORMULATIONS D'ÉPINÉPHRINE INTRANASALE ET MÉTHODES DE TRAITEMENT D'UNE MALADIE (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for epinephrine
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3678649 | LUC00378 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: COMBINAISON D'EPINEPHRINE ET DE DODECYLMALTOSIDE, SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20250211 |
| 3678649 | 2025C/508 | Belgium | ⤷ Start Trial | PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20240823 |
| 3678649 | CA 2025 00007 | Denmark | ⤷ Start Trial | PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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