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, Alembic, Amneal, Chartwell Rx, Cipla, Encube, Lupin Ltd, Padagis Us, Taro, and Zydus Lifesciences, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for tavaborole. Ten suppliers are listed for this compound.

Sponsor	Phase
Pfizer	Phase 4

Sponsor

Phase

Pfizer

Phase 4

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KERYDIN	Topical Solution	tavaborole	5%	204427	13	2018-07-09

Tradename

Dosage

Ingredient

Strength

NDA

ANDAs Submitted

Submissiondate

Topical Solution

2018-07-09

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212188-001	Oct 21, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Encube	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	211297-001	Oct 13, 2020	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212256-001	Nov 25, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212168-001	Feb 8, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212215-001	May 7, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	211963-001	Feb 3, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cipla	TAVABOROLE	tavaborole	SOLUTION;TOPICAL	212224-001	Feb 9, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	1
Patent Applications:	316
Drug Prices:	Drug price trends for tavaborole
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tavaborole
What excipients (inactive ingredients) are in tavaborole?	tavaborole excipients list
DailyMed Link:	tavaborole at DailyMed

Drug Class	Oxaborole Antifungal
Mechanism of Action	Protein Synthesis Inhibitors