KETOCONAZOLE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Ketoconazole, and what generic alternatives are available?
Ketoconazole is a drug marketed by Padagis Israel, Xiromed, Encube, Fougera Pharms, Teva, Trupharma, Cosette, Novitium Pharma, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, Sun Pharm Industries, and Taro. and is included in eighteen NDAs.
The generic ingredient in KETOCONAZOLE is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-eight 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for KETOCONAZOLE?
- What are the global sales for KETOCONAZOLE?
- What is Average Wholesale Price for KETOCONAZOLE?
Summary for KETOCONAZOLE
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 18 |
| Finished Product Suppliers / Packagers: | 25 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 243 |
| Patent Applications: | 4,096 |
| Drug Prices: | Drug price information for KETOCONAZOLE |
| Drug Sales Revenues: | Drug sales revenues for KETOCONAZOLE |
| DailyMed Link: | KETOCONAZOLE at DailyMed |
See drug prices for KETOCONAZOLE
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 |
| Universitas Padjadjaran | Phase 4 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva | KETOCONAZOLE | ketoconazole | TABLET;ORAL | 075273-001 | Jun 15, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cosette | KETOCONAZOLE | ketoconazole | SHAMPOO;TOPICAL | 076942-001 | Apr 11, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fougera Pharms | KETOCONAZOLE | ketoconazole | CREAM;TOPICAL | 076294-001 | Apr 28, 2004 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | KETOCONAZOLE | ketoconazole | TABLET;ORAL | 074971-001 | Jun 15, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 |
