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NIZORAL Drug Profile
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Which patents cover Nizoral, and what generic alternatives are available?
Nizoral is a drug marketed by Janssen Pharma, Janssen Pharms, and Kramer. and is included in five NDAs.
The generic ingredient in NIZORAL is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nizoral
A generic version of NIZORAL was approved as ketoconazole by TARO on June 15th, 1999.
Summary for NIZORAL
US Patents: | 0 |
Applicants: | 3 |
NDAs: | 5 |
Bulk Api Vendors: | 35 |
Clinical Trials: | 16 |
Patent Applications: | 1,438 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NIZORAL |
What excipients (inactive ingredients) are in NIZORAL? | NIZORAL excipients list |
DailyMed Link: | NIZORAL at DailyMed |



Recent Clinical Trials for NIZORAL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Douglas Pharmaceuticals America Ltd | Phase 1 |
Los Angeles Biomedical Research Institute | Early Phase 1 |
Wake Forest University Health Sciences | Early Phase 1 |
Pharmacology for NIZORAL
Drug Class | Azole Antifungal |
Mechanism of Action | Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors |
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 | Start Trial | Start Trial | Start Trial | ||||
Janssen Pharms | NIZORAL | ketoconazole | TABLET;ORAL | 018533-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Janssen Pharms | NIZORAL | ketoconazole | SHAMPOO;TOPICAL | 019927-001 | Aug 31, 1990 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Janssen Pharma | NIZORAL | ketoconazole | SUSPENSION;ORAL | 070767-001 | Nov 7, 1986 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Kramer | NIZORAL A-D | ketoconazole | SHAMPOO;TOPICAL | 020310-001 | Oct 10, 1997 | OTC | 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 NIZORAL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | NIZORAL | ketoconazole | SHAMPOO;TOPICAL | 019927-001 | Aug 31, 1990 | Start Trial | Start Trial |
Janssen Pharma | NIZORAL | ketoconazole | CREAM;TOPICAL | 019084-001 | Dec 31, 1985 | Start Trial | Start Trial |
Janssen Pharms | NIZORAL | ketoconazole | TABLET;ORAL | 018533-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Janssen Pharma | NIZORAL | ketoconazole | CREAM;TOPICAL | 019084-001 | Dec 31, 1985 | Start Trial | Start Trial |
Janssen Pharms | NIZORAL | ketoconazole | SHAMPOO;TOPICAL | 019927-001 | Aug 31, 1990 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NIZORAL
Country | Patent Number | Estimated Expiration |
---|---|---|
Switzerland | 644118 | Start Trial |
Yugoslavia | 40319 | Start Trial |
Greece | 62553 | Start Trial |
Latvia | 5015 | Start Trial |
Sweden | 7801088 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |