Generic for Adrenalin: Epinephrine

Yes. The generic name for Adrenalin is epinephrine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 7 Adrenalin products the Orange Book lists.

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Adrenalin products in the Orange Book

Adrenalin products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution, intramuscular, intravenous, subcutaneous	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	Marketed (Rx)	AP	2	AP
solution, intramuscular, intravenous, subcutaneous	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)	Marketed (Rx)	AP	4	AP
solution, intravenous	10MG/250ML (40MCG/ML)	Marketed (Rx)	None	0	None
solution, intravenous	2MG/250ML (8MCG/ML)	Marketed (Rx)	None	0	None
solution, intravenous	4MG/250ML (16MCG/ML)	Marketed (Rx)	None	0	None
solution, intravenous	5MG/250ML (20MCG/ML)	Marketed (Rx)	None	0	None
solution, intravenous	8MG/250ML (32MCG/ML)	Marketed (Rx)	None	0	None

NDA 204200, 204640, 215875, held by PH HEALTH LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic epinephrine

Approved generic versions of Adrenalin
Company	ANDA	TE code	Approved	Strengths
INTERNATIONAL MEDICATION SYSTEMS LTD	211880	AP (A-rated, therapeutically equivalent)	April 24, 2020	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)
AMERICAN REGENT INC	217192	AP (A-rated, therapeutically equivalent)	September 6, 2024	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)
AMNEAL EU LTD	217485	AP (A-rated, therapeutically equivalent)	October 14, 2025	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)
AMNEAL EU LTD	218208	AP (A-rated, therapeutically equivalent)	December 8, 2025	EQ 1MG BASE/ML (EQ 1MG BASE/ML)
ZYDUS PHARMACEUTICALS USA INC	219832	AP (A-rated, therapeutically equivalent)	September 14, 2026	EQ 30MG BASE/30ML (EQ 1MG BASE/ML)
APOTEX INC	220657	AP (A-rated, therapeutically equivalent)	September 15, 2026	EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Adrenalin patents

Patents listed for Adrenalin
Patent	Expires	Covers	Use code	NDA
9295657	March 13, 2035	Method of use	U-1829	204200
9119876	March 13, 2035	Drug product	None	204200
12280024	March 13, 2035	Drug product	None	204200
10130592	March 13, 2035	Drug product	None	204640
11083698	March 21, 2039	Method of use	U-3567	215875
10653646	March 21, 2039	Drug product	None	215875
11207280	March 21, 2039	Drug product	None	215875
12133837	March 21, 2039	Drug product	None	215875

Adrenalin NDC codes

Questions

Is there a generic for Adrenalin?

Yes. The generic name for Adrenalin is epinephrine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 7 Adrenalin products the Orange Book lists.

What is the generic name for Adrenalin?

The active ingredient in Adrenalin is epinephrine, per the FDA Orange Book.

When does the Adrenalin patent expire?

The last patent listed for Adrenalin in the Orange Book expires March 21, 2039. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

Generic for Adrenalin