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EXTINA Drug Profile
» See Plans and Pricing
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-four suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
US ANDA 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 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 89 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,876 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EXTINA |
| 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 |
Pharmacology for EXTINA
| Drug Class | Azole Antifungal |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors |
Paragraph IV (Patent) Challenges for EXTINA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EXTINA | AEROSOL, FOAM;TOPICAL | ketoconazole | 021738 | 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 | AT | RX | Yes | Yes | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Mylan | EXTINA | ketoconazole | AEROSOL, FOAM;TOPICAL | 021738-001 | Jun 12, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EXTINA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1692951 | Start Trial |
| Germany | 69836555 | Start Trial |
| Australia | 732456 | Start Trial |
| Japan | 4917204 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
