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Harvard Business School
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Generated: May 22, 2018

DrugPatentWatch Database Preview

DILAUDID-HP Drug Profile

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When do Dilaudid-hp patents expire, and when can generic versions of Dilaudid-hp launch?

Dilaudid-hp is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-nine patent family members in eleven countries.

The generic ingredient in DILAUDID-HP is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for DILAUDID-HP
Drug patent expirations by year for DILAUDID-HP
Pharmacology for DILAUDID-HP
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for DILAUDID-HP
Synonyms for DILAUDID-HP
(-)-(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
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
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 DILAUDID-HP

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-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-002 Aug 4, 1994 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Paragraph IV (Patent) Challenges for DILAUDID-HP
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 10 mg/mL ➤ Subscribe 2011-11-04

Non-Orange Book US Patents for DILAUDID-HP

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 ➤ Sign Up
9,545,473 Packaging system for oxygen-sensitive drugs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Cerilliant
Accenture
Farmers Insurance
Chinese Patent Office
UBS
Boehringer Ingelheim
Chubb
US Department of Justice

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