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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Covington
Argus Health
US Army
Deloitte
UBS
Cipla
Julphar
Cantor Fitzgerald

Generated: May 23, 2018

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ONMEL Drug Profile

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When do Onmel patents expire, and when can generic versions of Onmel launch?

Onmel is a drug marketed by Sebela Ireland Ltd and is included in one NDA. There is one patent protecting this drug.

This drug has eight patent family members in five countries.

The generic ingredient in ONMEL is itraconazole. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
Summary for ONMEL
International Patents:8
US Patents:1
Applicants:1
NDAs:1
Bulk Api Vendors: 53
Patent Applications: 22
Formulation / Manufacturing:see details
DailyMed Link:ONMEL at DailyMed
Drug patent expirations by year for ONMEL
Medical Subject Heading (MeSH) Categories for ONMEL
Synonyms for ONMEL
(1)-cis-4-(4-(4-(4-((2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2,4-dihydro-2-sec-butyl-3H-1,2,4-triazol-3-one
1-(butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one
2-(butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-2,4-dihydro-3H-1,2,4-triazol-3-one
2-butan-2-yl-4-[4-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one
24236-EP2281816A1
24236-EP2314590A1
2485AH
252964-65-1
3B1-008438
3H-1,2,4-Triazol-3-one, 4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-pipera-zinyl]phenyl]-2,4-dihydro-2-(1-methylpropyl)
4-?[4-?[4-?[4-?[[2-?(2,?4-?DICHLOROPHENYL)-?2-?(1H-?1,?2,?4-?TRIAZOL-?1-?YLMETHYL)-?1,?3-?DIOXOLAN-?4-?YL]METHOXY]PHENYL]-?1-?PIPERAZINYL]PHENYL]-?2,?4-?DIHYDRO-?2-?(1-?METHYLPROPYL)-?3H-?1,?2,?4-?TRIAZOL-?3-?ONE
4-(4-(4-(4-(((2R,4S)-2-((1H-1,2,4-triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-(sec-butyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
4-(4-{4-[4-({[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methyl}oxy)phenyl]piperazin-1-yl}phenyl)-2-(1-methylpropyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
4-[4-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-sec-butyl-1,2,4-triazol-3-one
4-[4-[4-[4-[[(2R,4S)-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazole-1-ylmethyl)-1,3-dioxolane-4-yl]methoxy]phenyl]piperazino]phenyl]-2-(1-methylpropyl)-4H-1,2,4-triazole-3(2H)-one
4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1h-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-2,4-dihydro-2-(1-methylpropyl)-3h-1,2,4-triazol-3-one
84604-65-9
84625-61-6
873066-43-4
A1-01739
AB0012897
AB01274818_02
AB01274818_03
AB01274818-01
AB2000585
AC-542
AC1L1IRU
AC1Q6EZ3
AKOS015842738
AKOS015961385
AN-15748
BC206651
BDBM50127138
C35H38Cl2N8O4
CAS-84625-61-6
CHEBI:6076
CHEMBL22587
CI0042
cis-Itraconazole
CS-2127
CTK8F8379
D00350
DB01167
DR003496
DRG-0044
DSSTox_CID_3180
DSSTox_GSID_23180
DSSTox_RID_76908
DTXSID3023180
EINECS 283-347-2
EN300-122640
FT-0601621
H151
HE153717
HE153718
HE396235
HY-17514
Intraconazole
ITCZ
Itraconazol
Itraconazol [Spanish]
itraconazole
Itraconazole (JP17/USAN)
Itraconazole (Sporanox)
Itraconazole & Nyotran
Itraconazole & Nyotran(Liposomal Nystatin)
Itraconazole 2.0 mg/ml in Dimethyl Sulfoxide
Itraconazole EP Impurity E
Itraconazolum
Itraconazolum [Latin]
Itrizole
Itrizole (TN)
ITZ
KS-1268
MCULE-2446846552
MLS006011958
MolPort-003-848-295
NCGC00018268-03
NCGC00274068-01
NCGC00274068-02
NE57775
NSC-759239
NSC759239
Oriconazole
Pharmakon1600-01505756
R 51211
R-51211
s2476
SBI-0206914.P001
SCHEMBL23934
SMR001827898
Sporanos
Sporanox
Sporanox (TN)
Sporanox(TM)
TL8005525
Tox21_110854
Tox21_110854_1
Triasporn
VHVPQPYKVGDNFY-ZPGVKDDISA-N

US Patents and Regulatory Information for ONMEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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 ONMEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 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 ONMEL

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
9,149,431 Itraconazole compositions with improved bioavailability ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Deloitte
Chubb
Moodys
US Department of Justice
Queensland Health
Merck
Dow
Johnson and Johnson

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