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Chinese Patent Office
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Medtronic
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Generated: July 20, 2018

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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 hydromorphone hydrochloride 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, 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 twenty-nine patent family members in eleven countries.

There are fourteen drug master file entries for hydromorphone hydrochloride. Twenty-five suppliers are listed for this compound.
Pharmacology for HYDROMORPHONE HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for HYDROMORPHONE HYDROCHLORIDE
Synonyms for HYDROMORPHONE HYDROCHLORIDE
(-)-(5R)-4,5-Epoxy-3-hydroxy-9alpha-methylmorphinan-6-one
(-)-Hydromorphone
(1S,5R,13R,17R)-10-hydroxy-4-methyl-12-oxa-4-azapentacyclo[9.6.1.0;{1,13}.0;{5,17}.0;{7,18}]octadeca-7(18),8,10-trien-14-one
(1S,5R,13R,17R)-10-HYDROXY-4-METHYL-12-OXA-4-AZAPENTACYCLO[9.6.1.0(1),(1)(3).0?,(1)?.0?,(1)?]OCTADECA-7(18),8,10-TRIEN-14-ONE
(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
(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)-3-hydroxy-17-methyl-4,5-epoxymorphinan-6-one
(5alpha)-4,5-Epoxy-3-hydroxy-17-methyl-morphinan-6-one hydrochloride
18145-12-5
3-hydroxy-17-methyl-4,5alpha-epoxymorphinan-6-one
4,5-alpha-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride
4,5-Epoxy-3-hydroxy-17-methylmorphinan-6-one
4,5alpha-Epoxy-3-hydroxy-17-methyl-6-morphinanone
4,5alpha-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride
41376-02-7
466-99-9
6-Deoxy-7,8-dihydro-6-oxomorphine
7,8-Dihydromorphinone
71-68-1
AN-23806
API0004807
BDBM50241341
C-33045
C07042
CC-29425
CHEBI:5790
CHEBI:5791
CHEMBL1237055
CHEMBL398707
D00839
D04JHN
D04LWO
D08047
DB00327
DEA No. 9150
Dihydromorfinon
Dihydromorfinon [Czech]
Dihydromorphinone
Dihydromorphinone HCl
Dihydromorphinone hydrochloride
dihydromorphone
Dilaudid
Dilaudid (TN)
Dilaudid hydrochloride
Dilaudid Oros
Dilaudid-hp
DiMo
Dimorphone
DTXSID8023133
EINECS 200-762-6
EINECS 207-383-5
Exalgo
Exalgo (TN)
GTPL7082
Hidromorfona
Hidromorfona [INN-Spanish]
HSDB 3341
Hydromorfona
Hydromorfona [Spanish]
Hydromorphon
hydromorphone
Hydromorphone (INN)
Hydromorphone [INN:BAN]
Hydromorphone 0.1 mg/ml in Methanol
Hydromorphone 1.0 mg/ml in Methanol
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--dea*schedule ii item
Hydromorphone hydrochloride, European Pharmacopoeia (EP) Reference Standard
Hydromorphone hydrochloride, United States Pharmacopeia (USP) Reference Standard
Hydromorphone prodrug
Hydromorphone prodrug (Bio-MD, tamper/abuse-resistant, pain), PharmacoFore
Hydromorphone prodrug (Bio-MD/MPAR/oral, pain), PharmacoFore
Hydromorphone prodrug (Bio-MD/MPAR/oral/extended-release, pain)
Hydromorphone prodrug (Bio-MD/MPAR/oral/extended-release, pain), PharmacoFore
Hydromorphone prodrug (tamper/abuse-resistant, Bio-MD/extended-release, Pain), PharmacoFore
Hydromorphone solution, 1 mg/mL in methanol, ampule of 1 mL, certified reference material
HYDROMORPHONEHYDROCHLORIDE
Hydromorphonum
Hydromorphonum [INN-Latin]
Hymorphan
Idromorfone
Idromorfone [DCIT]
L960UP2KRW
Laudacon
Laudicon
LS-187185
LS-92152
LS-92153
MFCD03427563
Morphinan-6-one, 4,5-alpha-epoxy-3-hydroxy-17-methyl-
Morphinan-6-one, 4,5-alpha-epoxy-3-hydroxy-17-methyl-, hydrochloride, (5'-alpha)-
Morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, (5alpha)-
Morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, hydrochloride, (5alpha)-
Morphinan-6-one, 4,5alpha-epoxy-3-hydroxy-17-methyl-
Morphinan-6-one, 4,5alpha-epoxy-3-hydroxy-17-methyl- (8CI)
Morphinan-6-one, 4,5alpha-epoxy-3-hydroxy-17-methyl-, hydrochloride
Morphinan-6-one, 4,5alpha-epoxy-3-hydroxy-17-methyl-, hydrochloride (8CI)
Morphinan-6-one, 4,5alpha-epoxy-3-hydroxy-17-methyl-(8CI)
Morphinan-6-one,5-epoxy-3-hydroxy-17-methyl-, (5.alpha.)-
Morphinan-6-one,5.alpha.-epoxy-3-hydroxy-17-methyl-
Morphinone, dihydro-
Morphinone, dihydro-, hydrochloride
Novolaudon
NSC 117862
NSC 19046
NSC-19046
NSC19046
Palladone
Palladone (TN)
Palladone SR (TN)
PF-03 program
PF-329
PL057001
Q812464R06
SCHEMBL2255
SCHEMBL30521
Tubex
UNII-L960UP2KRW
UNII-Q812464R06
WLN: T B6566 B6/CO 4ABBC R BX FV HO PN GHT&&TTJ JQ P1
WVLOADHCBXTIJK-YNHQPCIGSA-N
XHILEZUETWRSHC-NRGUFEMZSA-N
ZINC402954

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
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-004 Sep 24, 2004 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Paddock Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278-004 Sep 20, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurolife Pharma Llc HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 205814-002 May 13, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Elite Labs HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076723-001 Oct 18, 2005 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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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 ➤ Try a Free Trial ➤ Try a Free Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-004 Aug 24, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 Sep 24, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-001 Mar 1, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for HYDROMORPHONE HYDROCHLORIDE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,512,117 Hydromorphone and hydrocodone compositions and methods for their synthesis ➤ Try a Free Trial
9,545,473 Packaging system for oxygen-sensitive drugs ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
McKesson
Baxter
US Department of Justice
Merck
Mallinckrodt
Medtronic
Accenture
Dow

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