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:	24
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Sun Yat-sen University	Phase 2
University of Colorado, Denver	Phase 2
Boston University	Phase 4

See all CRISABOROLE clinical trials

Pharmacology for CRISABOROLE

Drug Class	Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CRISABOROLE

D11AH	Agents for dermatitis, excluding corticosteroids
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

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

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
Lithuania	C2343304		⤷ Sign Up
Mexico	335993	MOLECULAS PEQUEÑAS QUE CONTIENEN BORO. (BORON-CONTAINING SMALL MOLECULES.)	⤷ Sign Up
South Korea	101426220		⤷ Sign Up
Russian Federation	2010133524	БОРСОДЕРЖАЩИЕ МАЛЫЕ МОЛЕКУЛЫ	⤷ Sign Up
South Korea	101622870		⤷ Sign Up
South Africa	201506944	BORON-CONTAINING SMALL MOLECULES	⤷ Sign Up
>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	C202030031	Spain	⤷ Sign Up	PRODUCT NAME: CRISABOROL, OPCIONALMENTE EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1421; DATE OF AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1421; DATE OF FIRST AUTHORISATION IN EEA: 20200327
2343304	SPC/GB20/025	United Kingdom	⤷ Sign Up	PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/19/1421 20200401; UK PLGB 00057-1691 20200401
2343304	PA2020524	Lithuania	⤷ Sign Up	PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304	PA2020524,C2343304	Lithuania	⤷ Sign Up	PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304	20C1024	France	⤷ Sign Up	PRODUCT NAME: CRISABOROLE, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/19/1421 20200401
2343304	CR 2020 00022	Denmark	⤷ Sign Up	PRODUCT NAME: CRISABOROLE, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1421 20200401
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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