Generic for Dilaudid: Hydromorphone

Yes. The generic name for Dilaudid is hydromorphone. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP. Generics match 8 of the 9 Dilaudid products the Orange Book lists.

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Dilaudid products in the Orange Book

Dilaudid products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, injection	0.2MG/ML	Marketed (Rx)	AP	1	AP
injectable, injection	0.5MG/0.5ML	Marketed (Rx)	AP	1	AP
injectable, injection	1MG/ML	Marketed (Rx)	AP	1	AP
injectable, injection	2MG/ML	Marketed (Rx)	AP	2	AP
injectable, injection	4MG/ML	Marketed (Rx)	AP	0	None
solution, oral	5MG/5ML	Marketed (Rx)	AA	2	AA
tablet, oral	2MG	Marketed (Rx)	AB	3	AB
tablet, oral	4MG	Marketed (Rx)	AB	3	AB
tablet, oral	8MG	Marketed (Rx)	AB	3	AB

NDA 019034, 019891, 019892, held by FRESENIUS KABI USA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic hydromorphone

Approved generic versions of Dilaudid
Company	ANDA	TE code	Approved	Strengths
HIKMA PHARMACEUTICALS USA INC	074653	AA (A-rated, therapeutically equivalent)	July 29, 1998	5MG/5ML
SPECGX LLC	076855	AB (A-rated, therapeutically equivalent)	September 19, 2007	2MG, 4MG, 8MG
AUROLIFE PHARMA LLC	205814	AB (A-rated, therapeutically equivalent)	May 13, 2016	2MG, 4MG, 8MG
ASCENT PHARMACEUTICALS INC	210176	AA (A-rated, therapeutically equivalent)	October 27, 2017	5MG/5ML
ASCENT PHARMACEUTICALS INC	210506	AB (A-rated, therapeutically equivalent)	January 17, 2018	2MG, 4MG, 8MG
HIKMA PHARMACEUTICALS USA INC	202159	AP (A-rated, therapeutically equivalent)	April 27, 2018	2MG/ML
HIKMA PHARMACEUTICALS USA INC	216899	AP (A-rated, therapeutically equivalent)	February 9, 2024	0.2MG/ML, 0.5MG/0.5ML, 1MG/ML, 2MG/ML

Dilaudid patents

Patents listed for Dilaudid
Patent	Expires	Covers	Use code	NDA
9731082	April 23, 2032	Drug product	None	019034
9248229	March 12, 2034	Drug product	None	019034

Dilaudid NDC codes

Questions

Is there a generic for Dilaudid?

Yes. The generic name for Dilaudid is hydromorphone. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP. Generics match 8 of the 9 Dilaudid products the Orange Book lists.

What is the generic name for Dilaudid?

The active ingredient in Dilaudid is hydromorphone, per the FDA Orange Book.

When does the Dilaudid patent expire?

The last patent listed for Dilaudid in the Orange Book expires March 12, 2034. 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 Dilaudid