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Last Updated: January 22, 2020

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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 thirty-nine patent family members in fifteen countries.

The generic ingredient in DILAUDID-HP is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Sixteen 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
Recent Clinical Trials for DILAUDID-HP

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

SponsorPhase
National Heart, Lung, and Blood Institute (NHLBI)Phase 3
Duke UniversityPhase 3
MetroHealth Medical CenterPhase 4

See all DILAUDID-HP clinical trials

Pharmacology for DILAUDID-HP
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
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
(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
(5alpha)-3-hydroxy-17-methyl-4,5-epoxymorphinan-6-one
18145-12-5
3-hydroxy-17-methyl-4,5alpha-epoxymorphinan-6-one
4,5-Epoxy-3-hydroxy-17-methylmorphinan-6-one
4,5alpha-Epoxy-3-hydroxy-17-methyl-6-morphinanone
41376-02-7
466-99-9
6-Deoxy-7,8-dihydro-6-oxomorphine
7,8-Dihydromorphinone
BDBM50241341
C-33045
C07042
CC-29425
CHEBI:5790
CHEMBL398707
D08047
DB00327
DEA No. 9150
Dihydromorfinon
Dihydromorfinon [Czech]
Dihydromorphinone
Dilaudid
Dilaudid Oros
DiMo
Dimorphone
DTXSID8023133
EINECS 207-383-5
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 solution, 1 mg/mL in methanol, ampule of 1 mL, certified reference material
Hydromorphonum
Hydromorphonum [INN-Latin]
Idromorfone
Idromorfone [DCIT]
Laudacon
Laudicon
LS-187185
LS-92152
Morphinan-6-one, 4,5-alpha-epoxy-3-hydroxy-17-methyl-
Morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, (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,5-epoxy-3-hydroxy-17-methyl-, (5.alpha.)-
Morphinan-6-one,5.alpha.-epoxy-3-hydroxy-17-methyl-
Morphinone, dihydro-
Novolaudon
NSC 19046
NSC-19046
NSC19046
Palladone
Q812464R06
SCHEMBL2255
UNII-Q812464R06
WLN: T B6566 B6/CO 4ABBC R BX FV HO PN GHT&&TTJ JQ P1
WVLOADHCBXTIJK-YNHQPCIGSA-N
ZINC402954
Paragraph IV (Patent) Challenges for DILAUDID-HP
Tradename Dosage Ingredient NDA Submissiondate
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

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 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-002 Aug 4, 1994 DISCN No No   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-001 Jan 11, 1984 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-002 Aug 4, 1994 DISCN No No   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa DILAUDID-HP hydromorphone hydrochloride INJECTABLE;INJECTION 019034-002 Aug 4, 1994 DISCN No 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

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