Is there a generic for Hydromorphone hydrochloride?

Yes. The FDA Orange Book lists 22 approved generic (ANDA) applications for Hydromorphone hydrochloride, referencing the brand HYDROMORPHONE HYDROCHLORIDE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Hydromorphone hydrochloride?

HYDROMORPHONE HYDROCHLORIDE (NDA 217812, HIKMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Hydromorphone hydrochloride?

The Orange Book lists 2 patents against Hydromorphone hydrochloride products, with the earliest listed expiry in 2032. 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 Hydromorphone hydrochloride are approved?

Hydromorphone hydrochloride is approved in the following dosage forms: capsule, extended release, injectable, solution, tablet, tablet, extended release.

FDA Orange Book · active-ingredient family

Hydromorphone hydrochloride

Hydromorphone hydrochloride is approved as 7 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:HYDROMORPHONE HYDROCHLORIDE · NDA 217812

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, extended release, injectable, solution, tablet, tablet, extended release

Product	Applicant	Application	TE	Approved
HYDROMORPHONE HYDROCHLORIDERLD	HIKMA	NDA 217812	—	Dec 14, 2023
DILAUDIDRLD×7	FRESENIUS KABI USA	NDA 019034	AP	Jan 16, 2020
EXALGORLD×4	SPECGX LLC	NDA 021217	—	Mar 01, 2010
DILAUDIDRLD×3	RHODES PHARMS	NDA 019892	AB	Nov 09, 2007
DILAUDIDRLD	RHODES PHARMS	NDA 019891	AA	Dec 07, 1992
HYDROMORPHONE HYDROCHLORIDE×5	HOSPIRA INC	NDA 200403	—	Mar 03, 2023
PALLADONE×4	PURDUE PHARMA LP	NDA 021044	—	Sep 24, 2004

Generic (ANDA) products (22)

Product	Applicant	Application	TE	Approved
HYDROMORPHONE HYDROCHLORIDE×4	HIKMA	ANDA 216899	AP	Feb 09, 2024
HYDROMORPHONE HYDROCHLORIDE×4	ASCENT PHARMS INC	ANDA 212133	AB	Sep 23, 2020
HYDROMORPHONE HYDROCHLORIDE	GENUS	ANDA 207108	—	Apr 22, 2020
HYDROMORPHONE HYDROCHLORIDE	HIKMA	ANDA 202159	AP	Apr 27, 2018
HYDROMORPHONE HYDROCHLORIDE×3	ASCENT PHARMS INC	ANDA 210506	AB	Jan 17, 2018
HYDROMORPHONE HYDROCHLORIDE	ASCENT PHARMS INC	ANDA 210176	AA	Oct 27, 2017
HYDROMORPHONE HYDROCHLORIDE×5	OSMOTICA PHARM US	ANDA 205629	AB	Jul 07, 2016
HYDROMORPHONE HYDROCHLORIDE×3	AUROLIFE PHARMA LLC	ANDA 205814	AB	May 13, 2016
HYDROMORPHONE HYDROCHLORIDE×4	PADAGIS US	ANDA 204278	AB	Apr 06, 2015
HYDROMORPHONE HYDROCHLORIDE×4	ACTAVIS LABS FL INC	ANDA 202144	—	May 12, 2014
HYDROMORPHONE HYDROCHLORIDE	RISING	ANDA 078228	AP	Apr 14, 2010
HYDROMORPHONE HYDROCHLORIDE	RISING	ANDA 078261	AP	Apr 14, 2010
HYDROMORPHONE HYDROCHLORIDE×3	GENUS	ANDA 077471	—	Dec 09, 2009
HYDROMORPHONE HYDROCHLORIDE×2	HIKMA	ANDA 074597	—	May 29, 2009
HYDROMORPHONE HYDROCHLORIDE	HOSPIRA INC	ANDA 078591	AP	Jun 17, 2008
HYDROMORPHONE HYDROCHLORIDE×3	SPECGX LLC	ANDA 076855	AB	Sep 19, 2007
HYDROMORPHONE HYDROCHLORIDE×3	NESHER PHARMS	ANDA 077311	—	Nov 09, 2005
HYDROMORPHONE HYDROCHLORIDE	MPP PHARMA	ANDA 076723	—	Oct 18, 2005
HYDROMORPHONE HYDROCHLORIDE	BARR	ANDA 076444	—	Apr 25, 2003
HYDROMORPHONE HYDROCHLORIDE	HIKMA	ANDA 074653	AA	Jul 29, 1998
HYDROMORPHONE HYDROCHLORIDE	HOSPIRA	ANDA 074598	—	Jun 19, 1997
HYDROMORPHONE HYDROCHLORIDE	WATSON LABS	ANDA 074317	—	Aug 23, 1995

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9731082	Apr 23, 2032	in 5 yr 11 mo	Product
9248229	Mar 12, 2034	in 7 yr 10 mo	Product

Hydromorphone hydrochloride — frequently asked questions

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

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