KETOZOLE Drug Patent Profile
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When do Ketozole patents expire, and what generic alternatives are available?
Ketozole is a drug marketed by Taro and is included in one NDA.
The generic ingredient in KETOZOLE 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 Ketozole
A generic version of KETOZOLE was approved as ketoconazole by TARO on June 15th, 1999.
Summary for KETOZOLE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 47 |
| Patent Applications: | 1,521 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | KETOZOLE at DailyMed |
Pharmacology for KETOZOLE
| Drug Class | Azole Antifungal |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for KETOZOLE
US Patents and Regulatory Information for KETOZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taro | KETOZOLE | ketoconazole | CREAM;TOPICAL | 075638-001 | Dec 18, 2002 | AB | RX | 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 |
EU/EMA Drug Approvals for KETOZOLE
| 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 |
