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 |
|---|---|
| Fernando De la Garza Salazar | Phase 2 |
| Hospital Universitario Dr. Jose E. Gonzalez | 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 | ||||
| >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 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 | TABLET;ORAL | 018533-001 | Approved Prior to Jan 1, 1982 | ⤷ 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 |
|---|---|---|---|
| Philippines | 14635 | 1-(1,3-DIOKOLAN-2-YIMETHYL)-1H-IMIDAZOLES AND 1H-12,4-TRIAZOLES | ⤷ Try a Trial |
| Hong Kong | 9182 | 1-(1,3-DIOXOLAN-2-YLMETHYL)-1H-IMIDAZOLES AND 1H-1,2,4-TRIAZOLES | ⤷ Try a Trial |
| France | 2378778 | ⤷ Try a Trial | |
| Denmark | 42678 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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