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EXTINA Drug Profile
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See Plans and PricingWhen 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-six suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
US ANDA Litigation and Generic Entry Outlook for Extina
A generic version of EXTINA was approved as ketoconazole by TARO on June 15th, 1999.
Summary for EXTINA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 79 |
| Clinical Trials: | 2 |
| Patent Applications: | 6,649 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EXTINA |
| DailyMed Link: | EXTINA at DailyMed |
Recent Clinical Trials for EXTINA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St. Louis University | N/A |
| Stiefel, a GSK Company | Phase 4 |
| GlaxoSmithKline | Phase 4 |
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 | Start Trial | Start Trial | Start 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan | EXTINA | ketoconazole | AEROSOL, FOAM;TOPICAL | 021738-001 | Jun 12, 2007 | Start Trial | Start Trial |
| Mylan | EXTINA | ketoconazole | AEROSOL, FOAM;TOPICAL | 021738-001 | Jun 12, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
