HYDROMORPHONE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for hydromorphone hydrochloride and what is the scope of freedom to operate?

Hydromorphone hydrochloride is the generic ingredient in five branded drugs marketed by Purdue Pharma Lp, Fresenius Kabi Usa, Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Rhodes Pharms, Ascent Pharms Inc, Genus, Specgx Llc, Actavis Labs Fl Inc, Osmotica Pharm Us, Padagis Us, Aurolife Pharma Llc, Nesher Pharms, and Nostrum Labs Inc, and is included in twenty-nine NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydromorphone hydrochloride has twenty-two patent family members in twelve countries.

There are nine drug master file entries for hydromorphone hydrochloride. Fifteen suppliers are listed for this compound.

Summary for HYDROMORPHONE HYDROCHLORIDE

International Patents:	22
US Patents:	2
Tradenames:	5
Applicants:	18
NDAs:	29
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	301
Patent Applications:	2,708
Formulation / Manufacturing:	see details
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
University of Miami	Phase 2
Johns Hopkins University	Early Phase 1
Qianfoshan Hospital	Phase 4

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Osmotica Pharm Us	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205629-001	Jul 7, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-002	Sep 24, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	INJECTABLE;INJECTION	078261-001	Apr 14, 2010	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nesher Pharms	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET;ORAL	077311-002	Nov 9, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	INJECTABLE;INJECTION	078228-001	Apr 14, 2010	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rhodes Pharms	DILAUDID	hydromorphone hydrochloride	TABLET;ORAL	019892-003	Nov 9, 2007	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ascent Pharms Inc	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212133-002	Sep 23, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for HYDROMORPHONE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-003	Mar 1, 2010	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-002	Sep 24, 2004	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-003	Sep 24, 2004	⤷ Sign Up	⤷ Sign Up
Specgx Llc	EXALGO	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021217-001	Mar 1, 2010	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-004	Sep 24, 2004	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-001	Sep 24, 2004	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-003	Sep 24, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for HYDROMORPHONE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Denmark	2968729		⤷ Sign Up
Portugal	2968729		⤷ Sign Up
Canada	2902346	SYSTEME DE CONDITIONNEMENT POUR MEDICAMENTS SENSIBLES A L'OXYGENE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS)	⤷ Sign Up
Brazil	112015022171	sistema de embalagem para fármacos sensíveis ao oxigênio	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2014140097		⤷ Sign Up
Japan	2012510330		⤷ Sign Up
Australia	2014230836	Packaging system for oxygen-sensitive drugs	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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