XOLEGEL Drug Patent Profile
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Which patents cover Xolegel, and what generic alternatives are available?
Xolegel is a drug marketed by Almirall and is included in one NDA.
The generic ingredient in XOLEGEL 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 Xolegel
A generic version of XOLEGEL was approved as ketoconazole by TARO on June 15th, 1999.
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Summary for XOLEGEL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 3 |
| Patent Applications: | 4,116 |
| Drug Prices: | Drug price information for XOLEGEL |
| What excipients (inactive ingredients) are in XOLEGEL? | XOLEGEL excipients list |
| DailyMed Link: | XOLEGEL at DailyMed |
Recent Clinical Trials for XOLEGEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wake Forest University Health Sciences | Early Phase 1 |
| Mayo Clinic | Early Phase 1 |
| National Cancer Institute (NCI) | Early Phase 1 |
US Patents and Regulatory Information for XOLEGEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Almirall | XOLEGEL | ketoconazole | GEL;TOPICAL | 021946-001 | Jul 28, 2006 | DISCN | Yes | 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 |
Expired US Patents for XOLEGEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Almirall | XOLEGEL | ketoconazole | GEL;TOPICAL | 021946-001 | Jul 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Almirall | XOLEGEL | ketoconazole | GEL;TOPICAL | 021946-001 | Jul 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Almirall | XOLEGEL | ketoconazole | GEL;TOPICAL | 021946-001 | Jul 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for XOLEGEL
| 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 XOLEGEL
See the table below for patents covering XOLEGEL around the world.
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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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