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Last Updated: April 25, 2024

CRISABOROLE - Generic Drug Details

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What are the generic drug 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

Generic Entry Date for CRISABOROLE^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

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Glossary

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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
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Anacor Pharms Inc	EUCRISA	crisaborole	OINTMENT;TOPICAL	207695-001	Dec 14, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for CRISABOROLE

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for CRISABOROLE

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Country	Patent Number	Title	Estimated Expiration
China	102532180	Boron-containing small molecules	⤷ Try a Trial
China	101160124	Boron-containing small molecules	⤷ Try a Trial
Portugal	2719388		⤷ Try a Trial
Mexico	335993	MOLECULAS PEQUEÑAS QUE CONTIENEN BORO. (BORON-CONTAINING SMALL MOLECULES.)	⤷ Try a Trial
Brazil	PI0621279	moléculas pequenas contendo boro	⤷ Try a Trial
Russian Federation	2010133524	БОРСОДЕРЖАЩИЕ МАЛЫЕ МОЛЕКУЛЫ	⤷ Try a Trial
Slovenia	2987796		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CRISABOROLE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2343304	20C1024	France	⤷ Try a Trial	PRODUCT NAME: CRISABOROLE, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/19/1421 20200401
2343304	122020000038	Germany	⤷ Try a Trial	PRODUCT NAME: CRISABOROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304	PA2020524	Lithuania	⤷ Try a Trial	PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304	2020/024	Ireland	⤷ Try a 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	2020C/531	Belgium	⤷ Try a Trial	PRODUCT NAME: CRISABOROLE, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1421 20200401
2343304	C20200027 00352	Estonia	⤷ Try a Trial	PRODUCT NAME: KRISABOROOL;REG NO/DATE: EU/1/19/1421 01.04.2020
2343304	23/2020	Austria	⤷ Try a Trial	PRODUCT NAME: CRISABOROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/19/1421 (MITTEILUNG) 20200401
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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