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-seven 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: | 47 |
Clinical Trials: | 34 |
Patent Applications: | 1,512 |
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 |
---|---|
Hospital Universitario Dr. Jose E. Gonzalez | Phase 2 |
Fernando De la Garza Salazar | Phase 2 |
Milton S. Hershey Medical Center | Early Phase 1 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Pharms | NIZORAL | ketoconazole | TABLET;ORAL | 018533-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Pharms | NIZORAL | ketoconazole | SHAMPOO;TOPICAL | 019927-001 | Aug 31, 1990 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Janssen Pharma | NIZORAL | ketoconazole | SUSPENSION;ORAL | 070767-001 | Nov 7, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Kramer | NIZORAL ANTI-DANDRUFF | ketoconazole | SHAMPOO;TOPICAL | 020310-001 | Oct 10, 1997 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharma | NIZORAL | ketoconazole | CREAM;TOPICAL | 019084-001 | Dec 31, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | NIZORAL | ketoconazole | SHAMPOO;TOPICAL | 019927-001 | Aug 31, 1990 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | NIZORAL | ketoconazole | TABLET;ORAL | 018533-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharma | NIZORAL | ketoconazole | CREAM;TOPICAL | 019084-001 | Dec 31, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for NIZORAL
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
HRA Pharma Rare Diseases | Ketoconazole HRA | ketoconazole | EMEA/H/C/003906 Ketoconazole HRA is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years. |
Authorised | no | no | yes | 2014-11-18 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for NIZORAL
See the table below for patents covering NIZORAL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 186275 | 2-PHENYL-2-(1HIMIDAZOL-OR 1H-1,2,4-TRIAZOL)-1-YL-METHYL)-13-DIOXOLAN-4-YL GROUP DERIVATIVES AND ANTIFUNGAL AND ANTIBACTERIAL COMPOSITIONS | ⤷ Try a Trial |
Hong Kong | 9182 | 1-(1,3-DIOXOLAN-2-YLMETHYL)-1H-IMIDAZOLES AND 1H-1,2,4-TRIAZOLES | ⤷ Try a Trial |
Hungary | 177646 | PROCESS FOR PRODUCING NEW 1-BRACKET-1,3-DIOXOLANE-2-YL-METHYL-BRACKET CLOSED-1H-IMIDASOLE DERIVATIVES | ⤷ Try a Trial |
Norway | 148643 | ⤷ Try a Trial | |
Sweden | 7801088 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |