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Last Updated: June 25, 2021

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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, Akorn, Barr, Eurohlth Intl Sarl, Hospira, Hospira Inc, Watson Labs, Rhodes Pharms, Ascent Pharms Inc, Hikma, Lannett Co Inc, Specgx Llc, Actavis Labs Fl Inc, Osmotica, Paddock Labs Llc, 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 fourteen 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
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-HP INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-11-04
DILAUDID INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-11-04
DILAUDID INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-06-22
DILAUDID-HP 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
Lannett Co Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 077471-001 Dec 9, 2009 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Paddock Labs Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278-002 Apr 6, 2015 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Akorn HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 078228-001 Apr 14, 2010 AP RX No No   Get Started Free   Get Started Free   Get Started Free
Specgx Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855-003 Sep 19, 2007 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Ascent Pharms Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 212133-003 Sep 23, 2020 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Barr HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 076444-001 Apr 25, 2003 DISCN No No   Get Started Free   Get Started Free   Get Started Free
>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   Get Started Free   Get Started Free
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-003 Mar 1, 2010   Get Started Free   Get Started Free
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 Sep 24, 2004   Get Started Free   Get Started Free
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 Sep 24, 2004   Get Started Free   Get Started Free
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 Sep 24, 2004   Get Started Free   Get Started Free
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-002 Sep 24, 2004   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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