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Last Updated: March 19, 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 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-eight 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.

Recent Clinical Trials for HYDROMORPHONE HYDROCHLORIDE

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

SponsorPhase
University of MiamiPhase 2
Johns Hopkins UniversityEarly Phase 1
Qianfoshan HospitalPhase 4

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
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 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
Aurolife Pharma Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 205814-001 May 13, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Fl Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 202144-001 May 12, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 078228-001 Apr 14, 2010 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Osmotica Pharm Us HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205629-001 Jul 7, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-003 Apr 30, 2009 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 021044-001 Sep 24, 2004 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 Sep 24, 2004 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-004 Sep 24, 2004 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-001 Sep 24, 2004 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 Sep 24, 2004 ⤷  Try a Trial ⤷  Try a Trial
>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) 2010064074 ⤷  Try a Trial
China 204798475 ⤷  Try a Trial
European Patent Office 2376147 RÉCIPIENT DE MÉDICAMENT AMÉLIORÉ (IMPROVED DRUG CONTAINER) ⤷  Try a Trial
China 104528165 Packaging system for oxygen-sensitive drugs ⤷  Try a Trial
Denmark 2968729 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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