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Last Updated: March 28, 2024

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-six 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 suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for EPINEPHRINE

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Drug Sales Revenue Trends for EPINEPHRINE

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Recent Clinical Trials for EPINEPHRINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University Hospital "Sestre Milosrdnice"N/A
University of AlbertaPhase 1
Lawson Health Research InstituteN/A

See all EPINEPHRINE clinical trials

Generic filers with tentative approvals for EPINEPHRINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 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.

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
Par Sterile Products ADRENALIN epinephrine SOLUTION;INTRAVENOUS 215875-002 Apr 21, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Am Regent EPINEPHRINE epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 207568-001 Jul 6, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
Par Sterile Products ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 204200-001 Dec 7, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Par Sterile Products ADRENALIN epinephrine SOLUTION;INTRAVENOUS 215875-002 Apr 21, 2023 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
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-003 Nov 17, 2017 RX Yes No ⤷  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
United Kingdom 201104754 ⤷  Try a Trial
Canada 2644547 APPAREILS, SYSTEMES ET METHODES POUR ADMINISTRATION D'UN MEDICAMENT (DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY) ⤷  Try a Trial
European Patent Office 2355858 APPAREIL ET PROCÉDÉS POUR L'AUTO-ADMINISTRATION DE VACCINS ET D'AUTRES MÉDICAMENTS (APPARATUS AND METHODS FOR SELF-ADMINISTRATION OF VACCINES AND OTHER MEDICAMENTS) ⤷  Try a Trial
Canada 2586525 DISPOSITIFS, SYSTEMES ET PROCEDES D'ADMINISTRATION DE MEDICAMENTS (DEVICES, SYSTEMS, AND METHODS FOR MEDICAMENT DELIVERY) ⤷  Try a Trial
United Kingdom 201019599 ⤷  Try a Trial
European Patent Office 2125075 INJECTEUR MÉDICAL ÉQUIPÉ D'UN SYSTÈME DE DÉTECTION ET DE SURVEILLANCE DE L'OBSERVANCE (MEDICAL INJECTOR WITH COMPLIANCE TRACKING AND MONITORING) ⤷  Try a Trial
Canada 3033299 DISPOSITIFS, SYSTEMES ET PROCEDES POUR L'ADMINISTRATION DE MEDICAMENTS (DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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