EPINEPHRINE Drug Patent Profile

Which patents cover Epinephrine, and what generic alternatives are available?

Epinephrine is a drug marketed by Armstrong Pharms, Am Regent, Amneal, Baxter Hlthcare Corp, Bpi Labs, Fresenius Kabi Usa, Gland, Hikma, Intl Medication Sys, Hospira, and Teva Pharms Usa. and is included in seventeen NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in EPINEPHRINE is epinephrine bitartrate. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinephrine bitartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Epinephrine

Annual sales in 2022 were $454mm indicating the motivation for generic entry (peak sales were $610mm in 2019).

There have been thirty-two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (epinephrine bitartrate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for EPINEPHRINE

International Patents:	1
US Patents:	1
Applicants:	11
NDAs:	17
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	824
Patent Applications:	2,334
Drug Prices:	Drug price information 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

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

EPINEPHRINE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Armstrong Pharms	EPINEPHRINE	epinephrine	AEROSOL, METERED;INHALATION	087907-001	May 23, 1984		DISCN	No	No
Intl Medication Sys	EPINEPHRINE	epinephrine	SOLUTION;INTRAVENOUS	211363-001	Aug 15, 2022		RX	Yes	Yes
Baxter Hlthcare Corp	EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	epinephrine bitartrate	SOLUTION;INTRAVENOUS	218475-002	Mar 16, 2026		RX	Yes	Yes
Baxter Hlthcare Corp	EPINEPHRINE	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	220626-002	Mar 30, 2026		RX	Yes	Yes
Amneal	EPINEPHRINE	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	218208-001	Dec 8, 2025	AP	RX	No	No
Gland	EPINEPHRINE	epinephrine	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	219239-001	Feb 6, 2025	AP	RX	No	No

International Patents for EPINEPHRINE

See the table below for patents covering EPINEPHRINE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4755371	FORMULATIONS LIQUIDES D'ÉPINÉPHRINE (EPINEPHRINE LIQUID FORMULATIONS)

Supplementary Protection Certificates for EPINEPHRINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	LUC00378	Luxembourg		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		PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20240823

DrugChatter Q&A for EPINEPHRINE

Epinephrine patent expiration?
Adamis epinephrine 505 b 2?
Patent delist epinephrine?
When did the patent for epinephrine end?
Is epinephrine is patented in india?