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Tavaborole - Generic Drug Details

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What are the generic drug sources for tavaborole and what is the scope of freedom to operate?

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

See all tavaborole clinical trials

Generic filers with tentative approvals for TAVABOROLE

Applicant	Application No.	Strength	Dosage Form
		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					Y
Perrigo Pharma Intl	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	211848-001	Oct 13, 2020	AB	RX	No	No
Anacor Pharms Inc	KERYDIN	tavaborole	SOLUTION;TOPICAL	204427-001	Jul 7, 2014	AB	RX	Yes	Yes					Y
Encube	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	211297-001	Oct 13, 2020	AB	RX	No	No
Anacor Pharms Inc	KERYDIN	tavaborole	SOLUTION;TOPICAL	204427-001	Jul 7, 2014	AB	RX	Yes	Yes
Anacor Pharms Inc	KERYDIN	tavaborole	SOLUTION;TOPICAL	204427-001	Jul 7, 2014	AB	RX	Yes	Yes					Y

International Patents for tavaborole

Country	Patent Number	Estimated Expiration
Spain	2540966
Russian Federation	2010133524
New Zealand	578297
Japan	6109140
Hong Kong	1221956
Russian Federation	2008131324

Supplementary Protection Certificates for tavaborole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2343304	PA2020524	Lithuania		PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304	2020/024	Ireland		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		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		PRODUCT NAME: CRISABOROLE, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1421 20200401
2343304	2020C/531	Belgium		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		PRODUCT NAME: CRISABOROLE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1421 20200401