Is there a generic for Epinephrine?

Yes. The FDA Orange Book lists 11 approved generic (ANDA) applications for Epinephrine, referencing the brand EPINEPHRINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Epinephrine?

EPINEPHRINE (NDA 220626, BAXTER HLTHCARE CORP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Epinephrine?

The Orange Book lists 28 patents against Epinephrine products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Epinephrine are approved?

Epinephrine is approved in the following dosage forms: aerosol, metered, injectable, solution, spray.

FDA Orange Book · active-ingredient family

Epinephrine

Epinephrine: 17 brands, 11 generics; first approved May 23, 1984; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 11 ANDA applications approved.

Earliest patent expiry Jan 26, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 26, 2026

6 mo ago

Originator applications

Brand (NDA) products

EPINEPHRINERLDRS

BAXTER HLTHCARE CORPNDA 22062620262 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML (1MG/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	—
30MG/30ML (1MG/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	—

EPINEPHRINERLDRS

FRESENIUS KABI USANDA 2154252025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
30MG/30ML (1MG/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	—

NEFFYRLDRS

ARS PHARMS OPERATIONNDA 21469720252 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/SPRAY	SPRAY	NASAL	Rx	—
1MG/SPRAY	SPRAY	NASAL	Rx	—

EPINEPHRINERLDRS

BPI LABSNDA 20502920245 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML (1MG/ML)	SOLUTION	INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	Rx	AP
10MG/10ML (1MG/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	AP
1MG/ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION	INTRAVENOUS	Discontinued	—
30MG/30ML (1MG/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	AP
1MG/ML (1MG/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	AP

ADRENALINRLDRS

PH HEALTHNDA 21587520235 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/250ML (8MCG/ML)	SOLUTION	INTRAVENOUS	Rx	—
4MG/250ML (16MCG/ML)	SOLUTION	INTRAVENOUS	Rx	—
5MG/250ML (20MCG/ML)	SOLUTION	INTRAVENOUS	Rx	—
8MG/250ML (32MCG/ML)	SOLUTION	INTRAVENOUS	Rx	—
10MG/250ML (40MCG/ML)	SOLUTION	INTRAVENOUS	Rx	—

EPINEPHRINERLDRS

INTL MEDICATION SYSNDA 2113632022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/10ML (0.1MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

EPINEPHRINERLDRS

HOSPIRANDA 2093592019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/10ML (0.1MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

PRIMATENE MISTRLDRS

ARMSTRONG PHARMSNDA 2059202018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.125MG/INH	AEROSOL, METERED	INHALATION	OTC	—

SYMJEPIRLD

ADAMIS PHARMS CORPNDA 20753420182 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	Rx	—
0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	—

AUVI-QRLD

KALEO INCNDA 20173920173 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3MG/DELIVERY	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	Rx	BX
EQ 0.15MG/DELIVERY	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	Rx	BX
EQ 0.1MG/DELIVERY	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	Rx	—

ADRENALINRLDRS

PH HEALTHNDA 2046402013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	AP

ADRENALINRLDRS

PH HEALTHNDA 2042002012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	AP

ADRENACLICKRLDRS

IMPAXNDA 02080020094 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3MG/DELIVERY	INJECTABLE	INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	—
EQ 0.15MG/DELIVERY	INJECTABLE	INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	—
EQ 0.15MG/DELIVERY	INJECTABLE	INTRAMUSCULAR, SUBCUTANEOUS	Rx	BX
EQ 0.3MG/DELIVERY	INJECTABLE	INTRAMUSCULAR, SUBCUTANEOUS	Rx	BX

EPIPENRLDRS

VIATRISNDA 01943019874 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG/DELIVERY	INJECTABLE	INTRAMUSCULAR, SUBCUTANEOUS	Rx	AB
0.15MG/DELIVERY	INJECTABLE	INTRAMUSCULAR, SUBCUTANEOUS	Rx	AB
0.3MG/DELIVERY	INJECTABLE	INTRAMUSCULAR	Discontinued	—
0.15MG/DELIVERY	INJECTABLE	INTRAMUSCULAR	Discontinued	—

SUS-PHRINE SULFITE FREE

FOREST LABSNDA 00794219992 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	INJECTABLE	INJECTION	Discontinued	—
1.5MG/AMP	INJECTABLE	INJECTION	Discontinued	—

BRONKAID MIST

STERLINGNDA 016803—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.25MG/INH	AEROSOL, METERED	INHALATION	Discontinued	—

PRIMATENE MIST

WYETH CONSNDA 016126—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG/INH	AEROSOL, METERED	INHALATION	Discontinued	—

Abbreviated applications

Generic (ANDA) products (11)

EPINEPHRINE

HIKMAANDA 2205622026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML (1MG/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	AP

EPINEPHRINE

AMNEALANDA 2182082025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	AP

EPINEPHRINE

AMNEALANDA 2174852025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	AP

EPINEPHRINE

GLANDANDA 2181442025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML (1MG/ML)	SOLUTION	INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	Rx	AP

EPINEPHRINE

GLANDANDA 21923920252 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/10ML (1MG/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	AP
30MG/30ML (1MG/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	AP

EPINEPHRINE

FRESENIUS KABI USAANDA 2137082024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/ML (1MG/ML)	SOLUTION	INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS	Rx	AP

EPINEPHRINE

AM REGENTANDA 2171922024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	AP

EPINEPHRINE

INTL MEDICATION SYSANDA 2118802020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Rx	AP

EPINEPHRINE (AUTOINJECTOR)

TEVA PHARMS USAANDA 09058920182 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG/DELIVERY	INJECTABLE	INTRAMUSCULAR, SUBCUTANEOUS	Rx	AB
0.15MG/DELIVERY	INJECTABLE	INTRAMUSCULAR, SUBCUTANEOUS	Rx	AB

EPINEPHRINE

AM REGENTANDA 2075682018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Discontinued	—

EPINEPHRINE

ARMSTRONG PHARMSANDA 0879071984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG/INH	AEROSOL, METERED	INHALATION	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (28)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8367734	Jan 26, 2026	6 mo ago	Product
11590286	Dec 12, 2026	in 5 mo	Product
8206360	Feb 27, 2027	in 8 mo	Product
7947017	Mar 12, 2028	in 1 yr 8 mo	Product
8231573	Nov 25, 2028	in 2 yr 5 mo	Product
8226610	Apr 10, 2029	in 2 yr 9 mo	Product
8021344	Nov 02, 2029	in 3 yr 4 mo	Product
9295657	Mar 13, 2035	in 8 yr 10 mo	U-1829
9119876	Mar 13, 2035	in 8 yr 10 mo	Product
12280024	Mar 13, 2035	in 8 yr 10 mo	Product
10130592	Mar 13, 2035	in 8 yr 10 mo	Product
11141540	Oct 20, 2036	in 10 yr 5 mo	ProductU-3379
10688244	Dec 21, 2037	in 11 yr 7 mo	ProductU-2980
10842938	Dec 21, 2037	in 11 yr 7 mo	ProductU-2980
11771830	Dec 21, 2037	in 11 yr 7 mo	ProductU-2980
11173209	Feb 06, 2038	in 11 yr 9 mo	U-3979
10576156	Feb 06, 2038	in 11 yr 9 mo	Product
11918655	Feb 06, 2039	in 12 yr 9 mo	U-3979
11744895	Feb 06, 2039	in 12 yr 9 mo	U-3979
11717571	Feb 06, 2039	in 12 yr 9 mo	U-3979
11191838	Feb 06, 2039	in 12 yr 9 mo	ProductU-3979
10682414	Feb 06, 2039	in 12 yr 9 mo	U-3979
12324838	Feb 06, 2039	in 12 yr 9 mo	Product
11083698	Mar 21, 2039	in 12 yr 10 mo	U-3567
10653646	Mar 21, 2039	in 12 yr 10 mo	Product
11207280	Mar 21, 2039	in 12 yr 10 mo	Product
12133837	Mar 21, 2039	in 12 yr 10 mo	Product
12539283	Jan 17, 2045	in 18 yr 9 mo	Product

FDA approval span

Approval history

First approval

May 23, 1984

42 yr 9 mo ago

Most recent approval

May 29, 2026

2 mo ago

Approvals span 1984–2026 across 28 FDA applications.

Brand (NDA) 1761%

Generic (ANDA) 1139%

Epinephrine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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