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Last Updated: August 4, 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 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 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. Fifteen suppliers are listed for this compound.

Recent Clinical Trials for HYDROMORPHONE HYDROCHLORIDE

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

SponsorPhase
Hennepin Healthcare Research InstitutePhase 4
State University of New York at BuffaloPhase 3
Nanfang Hospital of Southern Medical UniversityPhase 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-HP INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-11-04
DILAUDID 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
Actavis Labs Fl Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 202144-004 Jun 30, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 200403-002 Dec 1, 2011 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 078591-001 Jun 17, 2008 AP RX No 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
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-002 Sep 24, 2004   Start Trial   Start Trial
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-002 Sep 24, 2004   Start Trial   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-003 Mar 1, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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