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EXTINA Drug Profile

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

Extina is a drug marketed by Mylan and is included in one NDA.

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

Summary for EXTINA

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	79
Clinical Trials:	2
Patent Applications:	7,162
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EXTINA
DailyMed Link:	EXTINA at DailyMed

See drug prices for EXTINA

Recent Clinical Trials for EXTINA

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

Sponsor	Phase
St. Louis University	N/A
GlaxoSmithKline	Phase 4
Stiefel, a GSK Company	Phase 4

See all EXTINA clinical trials

Pharmacology for EXTINA

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

BRD-K29113274-001-11-9

BRD-K29113274-001-21-8

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

HMS3713M19

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; Certified Reference Material

Ketoconazole, United States Pharmacopeia (USP) Reference Standard

Ketoconazole,(S)

Ketoconazolum

Ketoderm

KS-1205

KTN

KTZ

Kuric

KW-1414

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-

Prestwick_744

Prestwick0_000389

Prestwick1_000389

Prestwick2_000389

Prestwick3_000389

Q-201267

R 41,400

R 41400

R-41400

R41,400

R41400

rac-trans-Ketoconazole

s1353

SAM001246983

SCHEMBL8407

SMR000058460

SPBio_002498

SR-01000075626

SR-01000075626-1

SR-01000075626-4

SR-01000597381

SR-01000597381-1

SR-01000597381-6

ST2407064

SW196888-4

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

Paragraph IV (Patent) Challenges for EXTINA

Tradename	Dosage	Ingredient	NDA	Submissiondate
EXTINA	AEROSOL, FOAM;TOPICAL	ketoconazole	021738	2009-07-30

US Patents and Regulatory Information for EXTINA

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

Expired US Patents for EXTINA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007
Mylan	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007