➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
AstraZeneca
McKinsey
Express Scripts
Colorcon

Last Updated: June 4, 2020

DrugPatentWatch Database Preview

HYDROMORPHONE HYDROCHLORIDE Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

Which patents cover Hydromorphone Hydrochloride, 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, Hikma, Lannett Co Inc, Actavis Labs Fl Inc, Osmotica, Paddock Llc, Aurolife Pharma Llc, Nesher Pharms, Nostrum Labs Inc, and Specgx Llc. and is included in twenty-one NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Hydromorphone Hydrochloride

A generic version of HYDROMORPHONE HYDROCHLORIDE was approved as hydromorphone hydrochloride by HIKMA on July 29th, 1998.

  Start Trial

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

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

SponsorPhase
Medical College of WisconsinN/A
Dmitriy GromovPhase 4
Fujian Cancer HospitalPhase 2

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
(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
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 cii
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
NSC-117862
Palladone
Palladone (TN)
Q27106892
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 INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-06-22
DILAUDID-HP 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
Specgx Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855-002 Sep 19, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 074597-003 May 29, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Ascent Pharms Inc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 210506-003 Jan 17, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 074597-001 Jul 29, 1998 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
AstraZeneca
McKinsey
Express Scripts
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.