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EXTINA Drug Profile

Which patents cover Extina, and when can generic versions of Extina launch?

Extina is a drug marketed by Mylan Pharms Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in ten countries.

The generic ingredient in EXTINA is ketoconazole. There are fifteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

Summary for EXTINA

International Patents:	13
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	72
Clinical Trials:	2
Patent Applications:	4,553
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EXTINA
DailyMed Link:	EXTINA at DailyMed

Drug patent expirations by year for EXTINA

Pharmacology for EXTINA

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for EXTINA

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP3A Inhibitors

Synonyms for EXTINA

(+-)-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
Fungarest
Fungoral
HMS1569M19
HMS2051A19
HMS2089N05
HMS2096M19
HMS2234H17
HMS3262E13
HSDB 7447
HY-B0105A
J10202
K 1003
K0045
KCZ
Ketocanazole
Ketoconazol
ketoconazole
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 EXTINA

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Pharms Inc	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	AT	RX	Yes	Yes	➤ Try a Free Trial	➤ Try a Free Trial	Y			➤ Try a Free Trial
Mylan Pharms Inc	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	AT	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

Expired US Patents for EXTINA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Pharms Inc	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	➤ Try a Free Trial	➤ Try a Free Trial
Mylan Pharms Inc	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Paragraph IV (Patent) Challenges for EXTINA

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Foam	2%	➤ Subscribe	➤ Try a Free Trial

International Patents for EXTINA

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Country	Document Number	Estimated Expiration
Spain	2277394	➤ Try a Free Trial
Japan	4917204	➤ Try a Free Trial
Denmark	1024792	➤ Try a Free Trial
Austria	346588	➤ Try a Free Trial
Portugal	1024792	➤ Try a Free Trial
Japan	2001520184	➤ Try a Free Trial
Country	Document Number	Estimated Expiration

Summary for EXTINA

Pharmacology for EXTINA

Medical Subject Heading (MeSH) Categories for EXTINA

Synonyms for EXTINA

Paragraph IV (Patent) Challenges for EXTINA

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