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Generated: August 20, 2018

DrugPatentWatch Database Preview

Ketoconazole - Generic Drug Details

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What are the generic drug sources for ketoconazole and what is the scope of ketoconazole freedom to operate?

Ketoconazole is the generic ingredient in six branded drugs marketed by Mylan Pharms Inc, Perrigo Israel, Fougera Pharms, Teva, Taro, Janssen Pharma, Aqua Pharms, Perrigo New York, Tolmar, Janssen Pharms, Johnson And Johnson, Aaipharma Llc, Apotex, Mylan, Pliva, Strides Pharma, and Sun Pharm Industries, and is included in twenty-two NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ketoconazole has forty-one patent family members in fifteen countries.

There are fifteen drug master file entries for ketoconazole. Thirty-three suppliers are listed for this compound.

Pharmacology for ketoconazole
Medical Subject Heading (MeSH) Categories for ketoconazole
Synonyms for ketoconazole
(+-)-cis-1-Acetyl-4-(p-((2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazine
(+)-Ketoconazole
(+/-)-cis-1-Acetyl-4-(4-[(2-[2,4-dichlorophenyl]-2-[1H-imidazol-1-ylmethyl]-1,3-dioxolan-4-yl)-methoxy]phenyl)piperazine
(+/-)-cis-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
(2R,4S)-1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine
(2R,4S)-ketoconazole
1-(4-(4-(((2R,4S)-2-((1H-imidazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)ethan-1-one
1-(4-(4-(((2R,4S)-2-((1H-IMIDAZOL-1-YL)METHYL)-2-(2,4-DICHLOROPHENYL)-1,3-DIOXOLAN-4-YL)METHOXY)PHENYL)PIPERAZIN-1-YL)ETHANONE
1-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]ethan-1-one
1-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone
1-acetyl-4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine
142128-59-4
24F2-1,25(OH)D3
277K421
65277-42-1
AB0090681
AB02344
AC-15957
AC1L9UG3
AKOS007930650
API0003081
BDBM60666
BDBM8610
BIDD:GT0696
BIM-0050645.0001
BPBio1_000635
BRD-K29113274-001-03-6
BRN 4303081
BSPBio_000577
C26H28Cl2N4O4
CAS-65277-42-1
CCG-100815
CHEBI:48336
CHEMBL75
CIS-1-ACETYL-4-(4-((2-(2,4-DICHLOROPHENYL)-2-(1H-IMIDAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL)METHOXY)PHENYL)PIPERAZINE
cis-1-Acetyl-4-[4-[[2-(2,4-
cis-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxy]phenyl]piperazine
cis-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
CPD000058460
CS-1846
dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-piperazine
DRG-0073
DSSTox_CID_9879
DSSTox_GSID_29879
DSSTox_RID_78829
DTXSID7029879
EI-107
EINECS 265-667-4
EU-0100666
Extina
Fungarest
Fungoral
HMS1569M19
HMS2051A19
HMS2089N05
HMS2096M19
HMS2234H17
HMS3262E13
HSDB 7447
HY-B0105A
J10202
K 1003
K0045
KCZ
Ketocanazole
Ketoconazol
Ketoconazole (k)
Ketoconazole [USAN:INN:BAN:JAN]
Ketoconazole 2.0 mg/ml in Methanol
Ketoconazole, >=98% (HPLC)
Ketoconazole, Antibiotic for Culture Media Use Only
Ketoconazole, British Pharmacopoeia (BP) Reference Standard
Ketoconazole, European Pharmacopoeia (EP) Reference Standard
Ketoconazole, pharmaceutical secondary standard; traceable to USP and PhEur
Ketoconazole, United States Pharmacopeia (USP) Reference Standard
Ketoconazolum
Ketoderm
Ketoisdin
KS-1205
KTN
KTZ
Kuric
KZ
Lopac0_000666
LP00666
LS-110149
MCULE-2726394491
MFCD00058579
MLS000069784
MLS000758224
MLS001146934
MLS001423987
MLS002207053
MLS002222255
MolPort-003-848-307
MRF-0000100
NC00065
NCGC00016907-01
NCGC00025000-01
NCGC00025000-02
NCGC00025000-03
NCGC00025000-04
NCGC00025000-05
NCGC00025000-06
NCGC00025000-07
NCGC00025000-08
NCGC00025000-09
NCGC00025000-10
NCGC00253967-01
NCGC00261351-01
Nizoral
NSC 317629
Opera_ID_397
Piperazine, (+)-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-
Piperazine, (+/-)-1-acetyl-4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, rel-
Piperazine, 1-acetyl-4-(4-((2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-, cis-
Prestwick_744
Prestwick0_000389
Prestwick1_000389
Prestwick2_000389
Prestwick3_000389
Q-201267
R 41,400
R-41400
R41,400
R41400
rac-trans-Ketoconazole
s1353
SAM001246983
SCHEMBL8407
SMR000058460
SPBio_002498
SR-01000075626
SR-01000075626-1
SR-01000597381
SR-01000597381-6
ST2407064
Tocris-1103
Tox21_110676
Tox21_300267
Tox21_500666
UNII-R9400W927I component XMAYWYJOQHXEEK-OZXSUGGESA-N
UPCMLD-DP138
UPCMLD-DP138:001
US9150527, Ketoconazole
W-2941
Xolegel
ZINC643138

US Patents and Regulatory Information for ketoconazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aqua Pharms XOLEGEL ketoconazole GEL;TOPICAL 021946-001 Jul 28, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan KETOCONAZOLE ketoconazole TABLET;ORAL 075597-001 Dec 23, 1999 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms NIZORAL ketoconazole SHAMPOO;TOPICAL 019927-001 Aug 31, 1990 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aqua Pharms XOLEGEL ketoconazole GEL;TOPICAL 021946-001 Jul 28, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Tolmar KETOCONAZOLE ketoconazole SHAMPOO;TOPICAL 076942-001 Apr 11, 2005 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharma NIZORAL ketoconazole SUSPENSION;ORAL 070767-001 Nov 7, 1986 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva KETOCONAZOLE ketoconazole TABLET;ORAL 075273-001 Jun 15, 1999 AB RX No Yes ➤ Sign Up ➤ Sign Up ➤ 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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Expired US Patents for ketoconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms NIZORAL ketoconazole TABLET;ORAL 018533-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985 ➤ Sign Up ➤ Sign Up
Johnson And Johnson NIZORAL A-D ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997 ➤ Sign Up ➤ Sign Up
Janssen Pharms NIZORAL ketoconazole SHAMPOO;TOPICAL 019927-001 Aug 31, 1990 ➤ Sign Up ➤ Sign Up
Johnson And Johnson NIZORAL A-D ketoconazole SHAMPOO;TOPICAL 020310-001 Oct 10, 1997 ➤ Sign Up ➤ Sign Up
Janssen Pharma NIZORAL ketoconazole CREAM;TOPICAL 019084-001 Dec 31, 1985 ➤ Sign Up ➤ Sign Up
Janssen Pharms NIZORAL ketoconazole SHAMPOO;TOPICAL 019927-001 Aug 31, 1990 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for ketoconazole

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
8,586,066 Topical antifungal composition ➤ Sign Up
6,238,683 Anhydrous topical skin preparations ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Dow
Cerilliant
Daiichi Sankyo
US Department of Justice
Boehringer Ingelheim
Cantor Fitzgerald
Covington
Merck

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