EXTINA Drug Patent Profile
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Which patents cover Extina, and when can generic versions of Extina launch?
Extina is a drug marketed by Mylan and is included in one NDA.
The generic ingredient in EXTINA is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Extina
A generic version of EXTINA was approved as ketoconazole by TARO on June 15th, 1999.
Summary for EXTINA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 46 |
Clinical Trials: | 2 |
Patent Applications: | 1,543 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EXTINA |
What excipients (inactive ingredients) are in EXTINA? | EXTINA excipients list |
DailyMed Link: | EXTINA at DailyMed |


Recent Clinical Trials for EXTINA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
St. Louis University | N/A |
Stiefel, a GSK Company | Phase 4 |
GlaxoSmithKline | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for EXTINA
Paragraph IV (Patent) Challenges for EXTINA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EXTINA | Foam | ketoconazole | 2% | 021738 | 1 | 2009-07-30 |
US Patents and Regulatory Information for EXTINA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | EXTINA | ketoconazole | AEROSOL, FOAM;TOPICAL | 021738-001 | Jun 12, 2007 | AB | RX | Yes | Yes | ⤷ 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 EXTINA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan | EXTINA | ketoconazole | AEROSOL, FOAM;TOPICAL | 021738-001 | Jun 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Mylan | EXTINA | ketoconazole | AEROSOL, FOAM;TOPICAL | 021738-001 | Jun 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for EXTINA
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 EXTINA
See the table below for patents covering EXTINA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 69836555 | ⤷ Try a Trial | |
European Patent Office | 1692951 | ⤷ Try a Trial | |
Japan | 4917204 | ⤷ Try a Trial | |
Denmark | 1024792 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |