KERYDIN Drug Patent Profile

When do Kerydin patents expire, and when can generic versions of Kerydin launch?

Kerydin is a drug marketed by Anacor Pharms Inc and is included in one NDA.

The generic ingredient in KERYDIN is tavaborole. There are six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the tavaborole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kerydin

A generic version of KERYDIN was approved as tavaborole by ENCUBE on October 13^th, 2020.

Summary for KERYDIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	1
Patent Applications:	250
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for KERYDIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KERYDIN
What excipients (inactive ingredients) are in KERYDIN?	KERYDIN excipients list
DailyMed Link:	KERYDIN at DailyMed

See drug prices for KERYDIN

Recent Clinical Trials for KERYDIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer	Phase 4

See all KERYDIN clinical trials

Pharmacology for KERYDIN

Drug Class	Oxaborole Antifungal
Mechanism of Action	Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for KERYDIN

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for KERYDIN

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

US Patents and Regulatory Information for KERYDIN

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

International Patents for KERYDIN

When does loss-of-exclusivity occur for KERYDIN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KERYDIN around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	1853251
Israel	185080	BORON-CONTAINING SMALL MOLECULES, PHARMACEUTICAL FORMULATIONS COMPRISING THEM AND USE THEREOF IN THE PREPARATION OF MEDICAMENTS FOR TREATING INFECTIONS
South Africa	200707408	Boron-containing small molecules
Hungary	E040060

Supplementary Protection Certificates for KERYDIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2343304	2090017-1	Sweden		PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/19/1421 20200401
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	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