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Last Updated: June 24, 2021

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HYDROMORPHONE HYDROCHLORIDE Drug Profile


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

Hydromorphone Hydrochloride is a drug marketed by Akorn, Barr, Eurohlth Intl Sarl, Hospira, Hospira Inc, Watson Labs, Ascent Pharms Inc, Hikma, Lannett Co Inc, Actavis Labs Fl Inc, Osmotica, Paddock Labs Llc, Aurolife Pharma Llc, Nesher Pharms, Nostrum Labs Inc, and Specgx Llc. and is included in twenty-two 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.

Drug patent expirations by year for HYDROMORPHONE HYDROCHLORIDE
Recent Clinical Trials for HYDROMORPHONE HYDROCHLORIDE

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

SponsorPhase
University of British ColumbiaPhase 2/Phase 3
Fujian Cancer HospitalPhase 3
Stanford UniversityPhase 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
ATC Classes for HYDROMORPHONE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for HYDROMORPHONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
DILAUDID TABLET;ORAL hydromorphone hydrochloride 019892 2013-08-05
DILAUDID INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-11-04
DILAUDID-HP INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-11-04
DILAUDID-HP INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-06-22
DILAUDID INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-06-22
DILAUDID SOLUTION;ORAL hydromorphone hydrochloride 019891 2011-02-25
EXALGO TABLET, EXTENDED RELEASE;ORAL hydromorphone hydrochloride 021217 2010-09-02
EXALGO TABLET, EXTENDED RELEASE;ORAL hydromorphone hydrochloride 021217 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
Nesher Pharms HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 077311-001 Nov 9, 2005 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Ascent Pharms Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 210506-003 Jan 17, 2018 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Specgx Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855-002 Sep 19, 2007 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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Colorcon

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