HYDROMORPHONE HYDROCHLORIDE Drug Patent Profile

Which patents cover Hydromorphone Hydrochloride, and what generic alternatives are available?

Hydromorphone Hydrochloride is a drug marketed by Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Ascent Pharms Inc, Chartwell, Actavis Labs Fl Inc, Osmotica Pharm Us, Padagis Us, Aurolife Pharma Llc, Nesher Pharms, Nostrum Labs Inc, and Specgx Llc. and is included in twenty-four NDAs.

The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hydromorphone Hydrochloride

A generic version of HYDROMORPHONE HYDROCHLORIDE was approved as hydromorphone hydrochloride by HIKMA on July 29^th, 1998.

Summary for HYDROMORPHONE HYDROCHLORIDE

US Patents:	0
Applicants:	15
NDAs:	24
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	303
Patent Applications:	1,901
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HYDROMORPHONE HYDROCHLORIDE
What excipients (inactive ingredients) are in HYDROMORPHONE HYDROCHLORIDE?	HYDROMORPHONE HYDROCHLORIDE excipients list
DailyMed Link:	HYDROMORPHONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for HYDROMORPHONE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cure Addiction Now	Phase 3
Johns Hopkins University	Phase 3
University of Miami	Phase 2

See all HYDROMORPHONE HYDROCHLORIDE clinical trials

Pharmacology for HYDROMORPHONE HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for HYDROMORPHONE HYDROCHLORIDE

Analgesics, Opioid

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for HYDROMORPHONE HYDROCHLORIDE

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for HYDROMORPHONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DILAUDID-HP	Injection	hydromorphone hydrochloride	0.2 mg/mL	019034	1	2023-12-19
DILAUDID-HP	Injection	hydromorphone hydrochloride	0.5 mg/0.5 mL and 1 mg/mL	019034	1	2022-12-13
DILAUDID	Tablets	hydromorphone hydrochloride	2 mg, 4 mg, and 8 mg	019892	1	2013-08-05
DILAUDID-HP	Injection	hydromorphone hydrochloride	10 mg/mL	019034	1	2011-11-04
DILAUDID-HP	Injection	hydromorphone hydrochloride	2 mg/mL	019034	1	2011-06-22
DILAUDID	Oral Solution	hydromorphone hydrochloride	5 mg/5mL	019891	1	2011-02-25
EXALGO	Extended-release Tablets	hydromorphone hydrochloride	8 mg and 12 mg	021217	1	2010-09-02
EXALGO	Extended-release Tablets	hydromorphone hydrochloride	16 mg	021217	1	2010-08-02

US Patents and Regulatory Information for HYDROMORPHONE HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE is protected by zero US patents and two FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting HYDROMORPHONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurolife Pharma Llc	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET;ORAL	205814-002	May 13, 2016	AB	RX	No	No
Osmotica Pharm Us	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205629-004	Jul 7, 2016	AB	RX	No	Yes
Nesher Pharms	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET;ORAL	077311-002	Nov 9, 2005		DISCN	No	No
Chartwell	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET;ORAL	077471-001	Dec 9, 2009		DISCN	No	No
Nesher Pharms	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET;ORAL	077311-003	Nov 9, 2005		DISCN	No	No
Ascent Pharms Inc	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212133-004	Sep 23, 2020	AB	RX	No	No