Ketoconazole - Generic Drug Details
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What are the generic sources for ketoconazole and what is the scope of freedom to operate?
Ketoconazole
is the generic ingredient in six branded drugs marketed by Mylan, Padagis Israel, Xiromed, Encube, Fougera Pharms, Tasman Pharma, Teva, Taro, Janssen Pharma, Almirall, Tolmar, Janssen Pharms, Kramer, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, and Sun Pharm Industries, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.There are fifteen drug master file entries for ketoconazole. Twenty-seven suppliers are listed for this compound.
Summary for ketoconazole
US Patents: | 0 |
Tradenames: | 6 |
Applicants: | 20 |
NDAs: | 25 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 27 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Clinical Trials: | 242 |
Patent Applications: | 7,353 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for ketoconazole |
Drug Sales Revenues: | Drug sales revenues for ketoconazole |
What excipients (inactive ingredients) are in ketoconazole? | ketoconazole excipients list |
DailyMed Link: | ketoconazole at DailyMed |
Recent Clinical Trials for ketoconazole
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 |
Biostat Sp. z o.o. | Phase 2 |
Pharmacology for ketoconazole
Drug Class | Azole Antifungal |
Mechanism of Action | Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for ketoconazole
Paragraph IV (Patent) Challenges for KETOCONAZOLE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EXTINA | Foam | ketoconazole | 2% | 021738 | 1 | 2009-07-30 |
US Patents and Regulatory Information for ketoconazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Industries | KETOCONAZOLE | ketoconazole | TABLET;ORAL | 075314-001 | Jun 15, 1999 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Chartwell Rx | KETOCONAZOLE | ketoconazole | TABLET;ORAL | 074971-001 | Jun 15, 1999 | DISCN | No | 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 | ||||
Fougera Pharms | KETOCONAZOLE | ketoconazole | CREAM;TOPICAL | 076294-001 | Apr 28, 2004 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Encube | KETOCONAZOLE | ketoconazole | CREAM;TOPICAL | 212443-001 | May 20, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Almirall | XOLEGEL | ketoconazole | GEL;TOPICAL | 021946-001 | Jul 28, 2006 | DISCN | Yes | 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 ketoconazole
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 |
Almirall | XOLEGEL | ketoconazole | GEL;TOPICAL | 021946-001 | Jul 28, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharma | NIZORAL | ketoconazole | CREAM;TOPICAL | 019084-001 | Dec 31, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharma | NIZORAL | ketoconazole | CREAM;TOPICAL | 019084-001 | Dec 31, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
Mylan | EXTINA | ketoconazole | AEROSOL, FOAM;TOPICAL | 021738-001 | Jun 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | NIZORAL | ketoconazole | SHAMPOO;TOPICAL | 019927-001 | Aug 31, 1990 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ketoconazole
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 |
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