Crisaborole - Generic Drug Details

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

Crisaborole is the generic ingredient in one branded drug marketed by Anacor Pharms Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Crisaborole has one hundred and forty-eight patent family members in twenty-eight countries.

There are three drug master file entries for crisaborole. One supplier is listed for this compound.

Summary for crisaborole

International Patents:	148
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	23
Patent Applications:	386
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for crisaborole
What excipients (inactive ingredients) are in crisaborole?	crisaborole excipients list
DailyMed Link:	crisaborole at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for crisaborole

Dosage:

OINTMENT;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for crisaborole

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

Sponsor	Phase
University of Colorado, Denver	Phase 2
Boston University	Phase 4
Pfizer	Early Phase 1

See all crisaborole clinical trials

Pharmacology for crisaborole

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Paragraph IV (Patent) Challenges for CRISABOROLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EUCRISA	Topical Ointment	crisaborole	2%	207695	5	2021-06-14

US Patents and Regulatory Information for crisaborole

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	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes					Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes					Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes					Y
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes					Y

EU/EMA Drug Approvals for crisaborole

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Staquis	crisaborole	EMEA/H/C/004863 Staquis is indicated for treatment of mild to moderate atopic dermatitis in adults and paediatric patients from 2 years of age with ≤ 40% body surface area (BSA) affected.	Withdrawn	no	no	no	2020-03-27

International Patents for crisaborole

Country	Patent Number	Title	Estimated Expiration
France	20C1024
South Africa	201506944	BORON-CONTAINING SMALL MOLECULES
Canada	2597982	PETITES MOLECULES CONTENANT DU BORE (BORON-CONTAINING SMALL MOLECULES)
New Zealand	560448	Boron-containing small molecules
Japan	2015147795	抗炎症剤としてのホウ素含有小分子 (BORON-CONTAINING SMALL MOLECULES AS ANTI-INFLAMMATORY AGENTS)
South Korea	20100105869	BORON-CONTAINING SMALL MOLECULES

Supplementary Protection Certificates for crisaborole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2343304	LUC00157	Luxembourg		PRODUCT NAME: CRISABOROLE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE (CONFORME AUX REVENDICATIONS 30 ET 33 DU BREVET DE BASE); AUTHORISATION NUMBER AND DATE: EU/1/19/1421 20200401
2343304	122020000038	Germany		PRODUCT NAME: CRISABOROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304	C 2020 030	Romania		PRODUCT NAME: CRISABOROL SI SARURILE SALE FARMACEUTIC ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/19/1421; DATE OF NATIONAL AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1421; DATE OF FIRST AUTHORISATION IN EEA: 20200327
2343304	301049	Netherlands		PRODUCT NAME: CRISABOROLE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1421 20200401
2343304	C20200027 00352	Estonia		PRODUCT NAME: KRISABOROOL;REG NO/DATE: EU/1/19/1421 01.04.2020
2343304	2090017-1	Sweden		PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/19/1421 20200401