NIZORAL ANTI-DANDRUFF Drug Patent Profile
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Which patents cover Nizoral Anti-dandruff, and what generic alternatives are available?
Nizoral Anti-dandruff is a drug marketed by Kramer and is included in one NDA.
The generic ingredient in NIZORAL ANTI-DANDRUFF 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 Anti-dandruff
A generic version of NIZORAL ANTI-DANDRUFF was approved as ketoconazole by TARO on June 15th, 1999.
Summary for NIZORAL ANTI-DANDRUFF
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 47 |
| Patent Applications: | 1,521 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | NIZORAL ANTI-DANDRUFF at DailyMed |
Pharmacology for NIZORAL ANTI-DANDRUFF
| Drug Class | Azole Antifungal |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for NIZORAL ANTI-DANDRUFF
US Patents and Regulatory Information for NIZORAL ANTI-DANDRUFF
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 ANTI-DANDRUFF
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Kramer | NIZORAL ANTI-DANDRUFF | ketoconazole | SHAMPOO;TOPICAL | 020310-001 | Oct 10, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Kramer | NIZORAL ANTI-DANDRUFF | ketoconazole | SHAMPOO;TOPICAL | 020310-001 | Oct 10, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Kramer | NIZORAL ANTI-DANDRUFF | ketoconazole | SHAMPOO;TOPICAL | 020310-001 | Oct 10, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for NIZORAL ANTI-DANDRUFF
| 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 ANTI-DANDRUFF
See the table below for patents covering NIZORAL ANTI-DANDRUFF around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| U.S.S.R. | 786899 | METHOD OF PREPARING DERIVATIVES OF 1-(1,3-DIOXOLAN-2-YL-METHYL)-1H-IMIDAZOLES OR -1H-1,2,4-TRIAZOLES OR THEIR ACID-ADDITIVE SALTS IN THE FORM OF MIXTURE OR INDIVIDUAL STEREOISOMERS | ⤷ Try a Trial |
| Romania | 113608 | COMPOZITIE DE SAMPON DE PAR (HAIR SHAMPOO COMPOSITION) | ⤷ Try a Trial |
| Japan | S5395973 | AZOLE DERIVATIVES | ⤷ Try a Trial |
| Ireland | 780195 | ⤷ 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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