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Last Updated: December 12, 2024

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, Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Rhodes Pharms, Ascent Pharms Inc, Chartwell, 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. Seventeen suppliers are listed for this compound.

Summary for hydromorphone hydrochloride
Recent Clinical Trials for hydromorphone hydrochloride

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

SponsorPhase
Cure Addiction NowPhase 3
Johns Hopkins UniversityPhase 3
University of MiamiPhase 2

See all hydromorphone hydrochloride clinical trials

Pharmacology for hydromorphone hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for hydromorphone hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for hydromorphone hydrochloride
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

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Osmotica Pharm Us HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205629-002 Jul 7, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurolife Pharma Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 205814-003 May 13, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-003 Mar 1, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Labs Fl Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 202144-004 Jun 30, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Labs Fl Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 202144-002 May 12, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 200403-001 Dec 1, 2011 AP 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

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 ⤷  Sign Up ⤷  Sign Up
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 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
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-002 Mar 1, 2010 ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-004 Apr 30, 2009 ⤷  Sign Up ⤷  Sign Up
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-002 Sep 24, 2004 ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2010064074 ⤷  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
European Patent Office 2968729 SYSTÈME D'EMBALLAGE POUR MÉDICAMENTS SENSIBLES À L'OXYGÈNE (PACKAGING SYSTEM FOR OXYGEN-SENSITIVE DRUGS) ⤷  Sign Up
Spain 2695158 ⤷  Sign Up
European Patent Office 2376147 RÉCIPIENT DE MÉDICAMENT AMÉLIORÉ (IMPROVED DRUG CONTAINER) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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