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Last Updated: January 30, 2023

Hydromorphone hydrochloride - Generic Drug Details


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What are the generic drug sources for hydromorphone hydrochloride and what is the scope of patent protection?

Hydromorphone hydrochloride is the generic ingredient in five branded drugs marketed by Purdue Pharma Lp, Fresenius Kabi Usa, Akorn, Barr, Eurohlth Intl Sarl, Hospira, Hospira Inc, Watson Labs, Rhodes Pharms, Anda Repository, Ascent Pharms Inc, Hikma, 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-seven 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. Seventeen suppliers are listed for this compound.

Recent Clinical Trials for hydromorphone hydrochloride

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

SponsorPhase
William StoopsEarly Phase 1
Elina BrinckPhase 1
Xinhua Hospital, Shanghai Jiao Tong University School of MedicinePhase 2

See all hydromorphone hydrochloride clinical trials

Pharmacology for hydromorphone hydrochloride
Drug Class Opioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for hydromorphone hydrochloride
Paragraph IV (Patent) Challenges for HYDROMORPHONE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 076444-001 Apr 25, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 074317-001 Aug 23, 1995 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-002 Mar 1, 2010 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-004 Aug 24, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Osmotica Pharm Us HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205629-004 Jul 7, 2016 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Specgx Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855-003 Sep 19, 2007 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 Sep 24, 2004 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-002 Sep 24, 2004 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-001 Sep 24, 2004 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-004 Sep 24, 2004 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 Sep 24, 2004 See Plans and Pricing See Plans and Pricing
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-004 Aug 24, 2012 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-001 Sep 24, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for hydromorphone hydrochloride

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2014140097 See Plans and Pricing
Portugal 2376147 See Plans and Pricing
European Patent Office 3424547 SYSTÈME D'EMBALLAGE POUR MÉDICAMENTS SENSIBLES À L'OXYGÈNE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS) See Plans and Pricing
Hong Kong 1208015 用於氧敏感藥物的包裝系統 (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS) See Plans and Pricing
Japan 2016512455 酸素感受性薬物用の包装システム See Plans and Pricing
Australia 2014230836 Packaging system for oxygen-sensitive drugs See Plans and Pricing
China 104528165 Packaging system for oxygen-sensitive drugs See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.