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NIZORAL Drug Profile
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When do Nizoral patents expire, and when can generic versions of Nizoral launch?
The generic ingredient in NIZORAL is ketoconazole. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for NIZORAL
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 5 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 61 |
| Clinical Trials: | 11 |
| Patent Applications: | 4,554 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NIZORAL |
| DailyMed Link: | NIZORAL at DailyMed |
Pharmacology for NIZORAL
| Ingredient-type | Azoles |
| Drug Class | Azole Antifungal |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for NIZORAL
Synonyms for NIZORAL
| (+-)-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 |
| 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 |
| 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 NIZORAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharma | NIZORAL | ketoconazole | CREAM;TOPICAL | 019084-001 | Dec 31, 1985 | DISCN | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Janssen Pharms | NIZORAL | ketoconazole | TABLET;ORAL | 018533-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Janssen Pharms | NIZORAL | ketoconazole | SHAMPOO;TOPICAL | 019927-001 | Aug 31, 1990 | AB | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Janssen Pharma | NIZORAL | ketoconazole | SUSPENSION;ORAL | 070767-001 | Nov 7, 1986 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ 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 NIZORAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | NIZORAL | ketoconazole | SHAMPOO;TOPICAL | 019927-001 | Aug 31, 1990 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Janssen Pharma | NIZORAL | ketoconazole | CREAM;TOPICAL | 019084-001 | Dec 31, 1985 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Janssen Pharms | NIZORAL | ketoconazole | TABLET;ORAL | 018533-001 | Approved Prior to Jan 1, 1982 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Janssen Pharms | NIZORAL | ketoconazole | SHAMPOO;TOPICAL | 019927-001 | Aug 31, 1990 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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