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Efinaconazole - Generic Drug Details
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What are the generic sources for efinaconazole and what is the scope of freedom to operate?
Efinaconazole
is the generic ingredient in two branded drugs marketed by Perrigo Pharma Intl, Teva Pharms Usa, and Bausch, and is included in three NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Efinaconazole has seventy-five patent family members in twenty-three countries.
There are fourteen drug master file entries for efinaconazole. One supplier is listed for this compound.
Summary for efinaconazole
International Patents: | 75 |
US Patents: | 14 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 14 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 45 |
Clinical Trials: | 5 |
Patent Applications: | 540 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for efinaconazole |
DailyMed Link: | efinaconazole at DailyMed |
Recent Clinical Trials for efinaconazole
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dong-A ST Co., Ltd. | Phase 4 |
Western University of Health Sciences | Phase 3 |
Valeant Pharmaceuticals International, Inc. | Phase 4 |
Pharmacology for efinaconazole
Drug Class | Azole Antifungal |
Paragraph IV (Patent) Challenges for EFINACONAZOLE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
JUBLIA | SOLUTION;TOPICAL | efinaconazole | 203567 | 2018-06-06 |
US Patents and Regulatory Information for efinaconazole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bausch | JUBLIA | efinaconazole | SOLUTION;TOPICAL | 203567-001 | Jun 6, 2014 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Bausch | JUBLIA | efinaconazole | SOLUTION;TOPICAL | 203567-001 | Jun 6, 2014 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Bausch | JUBLIA | efinaconazole | SOLUTION;TOPICAL | 203567-001 | Jun 6, 2014 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Bausch | JUBLIA | efinaconazole | SOLUTION;TOPICAL | 203567-001 | Jun 6, 2014 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Bausch | JUBLIA | efinaconazole | SOLUTION;TOPICAL | 203567-001 | Jun 6, 2014 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for efinaconazole
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2015077729 | Start Trial |
Taiwan | 201309356 | Start Trial |
Japan | 2011508774 | Start Trial |
Russian Federation | 2519664 | Start Trial |
Japan | 6516759 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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