KETOCONAZOLE Drug Patent Profile
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Which patents cover Ketoconazole, and when can generic versions of Ketoconazole launch?
Ketoconazole is a drug marketed by Padagis Israel, Xiromed, Encube, Fougera Pharms, Tasman Pharma, Teva, Tolmar, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Rise Pharma, Strides Pharma, Sun Pharm Industries, and Taro. and is included in seventeen NDAs.
The generic ingredient in KETOCONAZOLE 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 Ketoconazole
A generic version of KETOCONAZOLE was approved as ketoconazole by TARO on June 15th, 1999.
Summary for KETOCONAZOLE
Recent Clinical Trials for KETOCONAZOLE
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 |
Maria Sklodowska-Curie National Research Institute of Oncology | 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
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Padagis Israel | KETOCONAZOLE | ketoconazole | AEROSOL, FOAM;TOPICAL | 091550-001 | Aug 25, 2011 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Padagis Israel | KETOCONAZOLE | ketoconazole | SHAMPOO;TOPICAL | 076419-001 | Jan 7, 2004 | AB | RX | No | Yes | ⤷ 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 | |||
Heritage Pharma | KETOCONAZOLE | ketoconazole | TABLET;ORAL | 075362-001 | Jun 15, 1999 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Tolmar | KETOCONAZOLE | ketoconazole | SHAMPOO;TOPICAL | 076942-001 | Apr 11, 2005 | 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 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 |