NIZORAL Drug Patent 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-five 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 |
Raw Ingredient (Bulk) Api Vendors: | 40 |
Clinical Trials: | 33 |
Patent Applications: | 1,465 |
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 |
---|---|
Milton S. Hershey Medical Center | Early Phase 1 |
Douglas Pharmaceuticals America Ltd | Phase 3 |
Novum Pharmaceutical Research Services | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for NIZORAL
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Janssen Pharms | NIZORAL | ketoconazole | TABLET;ORAL | 018533-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Janssen Pharms | NIZORAL | ketoconazole | SHAMPOO;TOPICAL | 019927-001 | Aug 31, 1990 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Janssen Pharma | NIZORAL | ketoconazole | SUSPENSION;ORAL | 070767-001 | Nov 7, 1986 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Kramer | NIZORAL ANTI-DANDRUFF | ketoconazole | SHAMPOO;TOPICAL | 020310-001 | Oct 10, 1997 | OTC | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 | See Plans and Pricing | See Plans and Pricing |
Janssen Pharma | NIZORAL | ketoconazole | CREAM;TOPICAL | 019084-001 | Dec 31, 1985 | See Plans and Pricing | See Plans and Pricing |
Janssen Pharms | NIZORAL | ketoconazole | SHAMPOO;TOPICAL | 019927-001 | Aug 31, 1990 | See Plans and Pricing | See Plans and Pricing |
Janssen Pharma | NIZORAL | ketoconazole | CREAM;TOPICAL | 019084-001 | Dec 31, 1985 | See Plans and Pricing | See Plans and Pricing |
Janssen Pharms | NIZORAL | ketoconazole | TABLET;ORAL | 018533-001 | Approved Prior to Jan 1, 1982 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NIZORAL
See the table below for patents covering NIZORAL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Italy | 7847837 | See Plans and Pricing | |
Israel | 53923 | 4-PHENOXYMETHYL-2-PHENYL-2-IMIDAZOLYL-(OR1,2,4-TRIAZOLYL)METHYL-1,3-DIOXOLANE DERIVATIVES,THEIR PREPARATION AND ANTIBACTERIAL AND ANTIFUNGAL COMPOSITIONS CONTAINING THEM | See Plans and Pricing |
Yugoslavia | 40319 | See Plans and Pricing | |
Australia | 3285078 | See Plans and Pricing | |
Norway | 148643 | See Plans and Pricing | |
Spain | 465981 | See Plans and Pricing | |
United Kingdom | 1594859 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |