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Last Updated: December 5, 2019

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Hydromorphone hydrochloride - Generic Drug Details

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What are the generic 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, West-ward Pharms Int, Specgx Llc, Actavis Labs Fl Inc, Osmotica, Paddock Llc, Aurolife Pharma Llc, Elite Labs, Lannett Co Inc, and Nesher Pharms, and is included in twenty-five 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-seven patent family members in fourteen countries.

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

Recent Clinical Trials for hydromorphone hydrochloride

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

SponsorPhase
University of Massachusetts, WorcesterPhase 4
Parc de Salut MarPhase 1
Jun WangPhase 4

See all hydromorphone hydrochloride clinical trials

Recent Litigation for hydromorphone hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Fresenius Kabi USA, LLC v. Eurohealth International Sarl2018-06-01
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-15
PURDUE PHARMACEUTICALS PRODUCTS L.P. v. LANNETT HOLDINGS, INC.2015-08-06

See all hydromorphone hydrochloride litigation

Pharmacology for hydromorphone hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for hydromorphone hydrochloride
Synonyms for hydromorphone hydrochloride
(4R,4aR,7aR,12bS)-9-hydroxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride
(5|A)-4,5-Epoxy-3-hydroxy-17-methyl-morphinan-6-one hydrochloride
(5alpha)-4,5-Epoxy-3-hydroxy-17-methyl-morphinan-6-one hydrochloride
4,5-alpha-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride
4,5alpha-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride
71-68-1
AN-23806
API0004807
CHEBI:5791
CHEMBL1237055
D00839
DEA No. 9150
Dihydromorphinone HCl
Dihydromorphinone hydrochloride
Dilaudid
Dilaudid (TN)
Dilaudid hydrochloride
Dilaudid-hp
EINECS 200-762-6
Exalgo
Exalgo (TN)
Hydromorphone HCL
Hydromorphone hydrochloride (JAN/USP)
Hydromorphone hydrochloride [USAN]
Hydromorphone hydrochloride [USP]
Hydromorphone hydrochloride solution, drug standard, 1.0 mg/mL in methanol
Hydromorphone Hydrochloride USP
Hydromorphone hydrochloride, European Pharmacopoeia (EP) Reference Standard
Hydromorphone hydrochloride, United States Pharmacopeia (USP) Reference Standard
Hymorphan
L960UP2KRW
LS-92153
MFCD03427563
Morphinan-6-one, 4,5-alpha-epoxy-3-hydroxy-17-methyl-, hydrochloride, (5'-alpha)-
Morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, hydrochloride, (5alpha)-
Morphinan-6-one, 4,5alpha-epoxy-3-hydroxy-17-methyl-, hydrochloride
Morphinan-6-one, 4,5alpha-epoxy-3-hydroxy-17-methyl-, hydrochloride (8CI)
Morphinone, dihydro-, hydrochloride
NSC 117862
Palladone
Palladone (TN)
SCHEMBL30521
Tubex
UNII-L960UP2KRW
XHILEZUETWRSHC-NRGUFEMZSA-N
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
Aurolife Pharma Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 205814-001 May 13, 2016 AB RX No 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
Osmotica HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205629-002 Jul 7, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Paddock Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278-003 Apr 6, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-004 Apr 30, 2009 AP RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Eurohlth Intl Sarl HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 202159-001 Apr 27, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-005 Apr 30, 2009 DISCN Yes No   Start Trial   Start Trial Y   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 021217-001 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 021044-004 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
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
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-004 Aug 24, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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