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Tavaborole - Generic Drug Details
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Tavaborole
is the generic ingredient in two branded drugs marketed by Anacor Pharms Inc, Aleor Dermaceuticals, Amneal, Encube, and Perrigo Pharma Intl, and is included in five NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Tavaborole has eighty-five patent family members in twenty-three countries.
There are six drug master file entries for tavaborole. Six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for tavaborole
International Patents: | 85 |
US Patents: | 5 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 5 |
Drug Master File Entries: | 6 |
Suppliers / Packagers: | 6 |
Bulk Api Vendors: | 79 |
Clinical Trials: | 1 |
Patent Applications: | 317 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tavaborole |
DailyMed Link: | tavaborole at DailyMed |
Recent Clinical Trials for tavaborole
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Pfizer | Phase 4 |
Generic filers with tentative approvals for TAVABOROLE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 5% | SOLUTION;TOPICAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for tavaborole
Drug Class | Oxaborole Antifungal |
Mechanism of Action | Protein Synthesis Inhibitors |
Paragraph IV (Patent) Challenges for TAVABOROLE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
KERYDIN | SOLUTION;TOPICAL | tavaborole | 204427 | 2018-07-09 |
US Patents and Regulatory Information for tavaborole
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Anacor Pharms Inc | KERYDIN | tavaborole | SOLUTION;TOPICAL | 204427-001 | Jul 7, 2014 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Perrigo Pharma Intl | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 211848-001 | Oct 13, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Anacor Pharms Inc | KERYDIN | tavaborole | SOLUTION;TOPICAL | 204427-001 | Jul 7, 2014 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Encube | TAVABOROLE | tavaborole | SOLUTION;TOPICAL | 211297-001 | Oct 13, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Anacor Pharms Inc | KERYDIN | tavaborole | SOLUTION;TOPICAL | 204427-001 | Jul 7, 2014 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Anacor Pharms Inc | KERYDIN | tavaborole | SOLUTION;TOPICAL | 204427-001 | Jul 7, 2014 | AB | 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 tavaborole
Country | Patent Number | Estimated Expiration |
---|---|---|
Spain | 2540966 | Start Trial |
Russian Federation | 2010133524 | Start Trial |
New Zealand | 578297 | Start Trial |
Japan | 6109140 | Start Trial |
Hong Kong | 1221956 | Start Trial |
Russian Federation | 2008131324 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for tavaborole
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2343304 | PA2020524 | Lithuania | Start Trial | PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 20200327 |
2343304 | 2020/024 | Ireland | Start Trial | PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/19/1421/001 EU/1/19/1421/004 20200327 |
2343304 | CA 2020 00022 | Denmark | Start Trial | PRODUCT NAME: CRISABOROLE, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1421 20200401 |
2343304 | CR 2020 00022 | Denmark | Start Trial | PRODUCT NAME: CRISABOROLE, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1421 20200401 |
2343304 | 2020C/531 | Belgium | Start Trial | PRODUCT NAME: CRISABOROLE, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1421 20200401 |
2343304 | 301049 | Netherlands | Start Trial | PRODUCT NAME: CRISABOROLE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1421 20200401 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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