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Last Updated: October 26, 2020

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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 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, 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-six NDAs. There are three patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydromorphone hydrochloride has thirty-nine patent family members in fifteen countries.

There are fourteen drug master file entries for hydromorphone hydrochloride. Sixteen suppliers are listed for this compound.

Recent Clinical Trials for hydromorphone hydrochloride

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

SponsorPhase
University of California, San FranciscoPhase 4
Nanfang Hospital of Southern Medical UniversityPhase 4
Hennepin Healthcare Research InstitutePhase 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 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
Osmotica HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205629-003 Jul 7, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-001 Mar 1, 2010 DISCN Yes No   Start Trial   Start Trial   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-003 Mar 1, 2010 DISCN Yes No   Start Trial   Start Trial   Start 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
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-004 Aug 24, 2012   Start Trial   Start Trial
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-001 Sep 24, 2004   Start Trial   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-002 Mar 1, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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