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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

HYDROMORPHONE HYDROCHLORIDE Drug Profile

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When do Hydromorphone Hydrochloride patents expire, and what generic alternatives are available?

Hydromorphone Hydrochloride is a drug marketed by Akorn, Barr, Eurohlth Intl Sarl, Hospira, Hospira Inc, Watson Labs, Ascent Pharms Inc, West-ward Pharms Int, Actavis Labs Fl Inc, Osmotica, Paddock Llc, Aurolife Pharma Llc, Elite Labs, Lannett Co Inc, Nesher Pharms, and Specgx Llc. and is included in twenty NDAs.

The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Drug patent expirations by year for HYDROMORPHONE HYDROCHLORIDE
Recent Clinical Trials for HYDROMORPHONE HYDROCHLORIDE

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SponsorPhase
Parc de Salut MarPhase 1
National Heart, Lung, and Blood Institute (NHLBI)Phase 3
Duke UniversityPhase 3

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Recent Litigation for HYDROMORPHONE HYDROCHLORIDE

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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

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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-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
West-ward Pharms Int HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 074597-003 May 29, 2009 AB RX No No   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
Aurolife Pharma Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 205814-001 May 13, 2016 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

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