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Last Updated: November 17, 2019

DrugPatentWatch Database Preview

DILAUDID Drug Profile

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

Dilaudid is a drug marketed by Fresenius Kabi Usa and Rhodes Pharms and is included in three NDAs. There are three patents protecting this drug and four Paragraph IV challenges.

This drug has thirty-seven patent family members in fourteen countries.

The generic ingredient in DILAUDID 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 DILAUDID
Drug Prices for DILAUDID

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Drug Sales Revenue Trends for DILAUDID

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Recent Clinical Trials for DILAUDID

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

See all DILAUDID clinical trials

Recent Litigation for DILAUDID

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District Court Litigation
Case NameDate
Fresenius Kabi USA, LLC v. Eurohealth International Sarl2018-06-01
PURDUE PHARMACEUTICALS PRODUCTS L.P. v. LANNETT HOLDINGS, INC.2015-08-06
Purdue Pharmaceutical Products L.P. v. Hospira, Inc.2010-10-08

See all DILAUDID litigation

Pharmacology for DILAUDID
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Synonyms for DILAUDID
(-)-(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 Oros
Dilaudid-hp
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
Tradename Dosage Ingredient NDA Submissiondate
DILAUDID TABLET;ORAL hydromorphone hydrochloride 019892 2013-08-05
DILAUDID INJECTABLE;INJECTION hydromorphone hydrochloride 019034 2011-11-04
DILAUDID-HP 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

US Patents and Regulatory Information for DILAUDID

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 hydromorphone hydrochloride INJECTABLE;INJECTION 019034-003 Apr 30, 2009 AP RX Yes Yes   Start Trial   Start Trial Y 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 hydromorphone hydrochloride INJECTABLE;INJECTION 019034-005 Apr 30, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-004 Apr 30, 2009 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Rhodes Pharms DILAUDID hydromorphone hydrochloride TABLET;ORAL 019892-002 Nov 9, 2007 AB RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-005 Apr 30, 2009 DISCN Yes No   Start Trial   Start Trial Y 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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