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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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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.
ISSN: 2162-2639
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