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Last Updated: April 24, 2024

Epinephrine - Generic Drug Details

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What are the generic drug 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 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 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:	20
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

See drug prices for epinephrine

Drug Sales Revenue Trends for epinephrine

See drug sales revenues for epinephrine

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

See all epinephrine clinical trials

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

Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Bronchodilator Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents

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

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Glossary

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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	201739-003	Nov 17, 2017		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Hospira	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	089644-001	Jun 21, 1988	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bpi Labs	EPINEPHRINE	epinephrine	SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	205029-001	Jul 29, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y		Y	⤷ Try a Trial
Septodont	OCTOCAINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	084048-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Adamis Pharms Corp	SYMJEPI	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	207534-001	Jun 15, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Fresenius Kabi Usa	XYLOCAINE W/ EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	006488-005	Approved Prior to Jan 1, 1982		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eastman Kodak	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	040057-002	Feb 26, 1993		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

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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

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Country	Patent Number	Title	Estimated Expiration
Cyprus	1122922		⤷ Try a Trial
Canada	3199029	DISPOSITIFS DE TYPE SERINGUE (SYRINGE DEVICES)	⤷ Try a Trial
Cyprus	1117076		⤷ Try a Trial
Israel	209219	מתקן להעברת התרופה בעל מערכת מעגל אלקטרוני (Medicament delivery device having an electronic circuit system)	⤷ Try a Trial
United Kingdom	2451769	An interactive auto-injector	⤷ Try a Trial
Mexico	2007009152	DISPOSITIVOS, SISTEMA Y METODOS PARA EL SUMINISTRO DE MEDICAMENTOS. (DEVICES, SYSTEMS, AND METHODS FOR MEDICAMENT DELIVERY.)	⤷ Try a Trial
Poland	1786491		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.