Epinephrine - Generic Drug Details

What are the generic sources for epinephrine and what is the scope of patent protection?

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
Patent Applications:	5,884
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

See drug sales revenues for epinephrine

Recent Clinical Trials for epinephrine

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

Sponsor	Phase
University of California, San Francisco	PHASE2
Goldman, Butterwick, Fitzpatrick and Groff	PHASE4
Hospital del Trabajador de Santiago	NA

See all epinephrine clinical trials

Generic filers with tentative approvals for EPINEPHRINE

Applicant	Application No.	Strength	Dosage Form
		EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
		EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION;INTRAVENOUS
		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

Adrenergic alpha-Agonists

Adrenergic beta-Agonists

Bronchodilator Agents

Mydriatics

Sympathomimetics

Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for epinephrine

A01AD	Other agents for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

B02BC	Local hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AA	Alpha- and beta-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Viatris	EPI E Z PEN JR	epinephrine	INJECTABLE;INTRAMUSCULAR	019430-004	Aug 3, 1995		DISCN	No	No
Teva Pharms Usa	EPINEPHRINE (AUTOINJECTOR)	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	090589-002	Aug 16, 2018	AB	RX	No	No
Ph Health	ADRENALIN	epinephrine	SOLUTION;INTRAVENOUS	215875-004	Apr 21, 2023		RX	Yes	Yes	11,083,698
Bel Mar	PROCAINE HYDROCHLORIDE W/ EPINEPHRINE	epinephrine; procaine hydrochloride	INJECTABLE;INJECTION	080758-001	Approved Prior to Jan 1, 1982		DISCN	No	No

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	201739-002	Aug 10, 2012	9,278,182
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-002	Aug 10, 2012	8,016,788
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-001	Aug 10, 2012	9,056,170
Kaleo Inc	AUVI-Q	epinephrine	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	201739-001	Aug 10, 2012	9,149,579

International Patents for epinephrine

Country	Patent Number	Title	Estimated Expiration
Australia	2016233682	Epinephrine formulations
Canada	2978464	FORMULATIONS D'EPINEPHRINE (EPINEPHRINE FORMULATIONS)
China	107614017	肾上腺素制剂 (EPINEPHRINE FORMULATIONS)
European Patent Office	3268045	FORMULATIONS D'ÉPINÉPHRINE (EPINEPHRINE FORMULATIONS)

Supplementary Protection Certificates for epinephrine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	2025C/508	Belgium		PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20240823
3678649	C20250011	Finland
3678649	PA2025507	Lithuania		PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	122025000010	Germany		PRODUCT NAME: KOMBINATION AUS EPINEPHRIN AND DODECYLMALTOSID, IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1846 20240822