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Last Updated: August 10, 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
State University of New York at BuffaloPhase 3
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-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
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-006 Jan 16, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Lannett Co Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 077471-002 Dec 9, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Rhodes Pharms DILAUDID hydromorphone hydrochloride TABLET;ORAL 019892-002 Nov 9, 2007 AB RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Hospira Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 200403-003 Dec 1, 2011 AP RX No No   Start Trial   Start Trial   Start Trial
Ascent Pharms Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 210506-001 Jan 17, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Specgx Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855-001 Dec 23, 2004 AB 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 021044-004 Sep 24, 2004   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
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-003 Mar 1, 2010   Start Trial   Start Trial
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-004 Sep 24, 2004   Start Trial   Start Trial
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 Sep 24, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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