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Last Updated: December 4, 2022

Crisaborole - Generic Drug Details


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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-four patent family members in twenty-seven countries.

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

Summary for crisaborole
Recent Clinical Trials for crisaborole

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

SponsorPhase
University of Colorado, DenverPhase 2
Boston UniversityPhase 4
University of California, IrvineEarly Phase 1

See all crisaborole clinical trials

Pharmacology for crisaborole
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Anacor Pharms Inc EUCRISA crisaborole OINTMENT;TOPICAL 207695-001 Dec 14, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Anacor Pharms Inc EUCRISA crisaborole OINTMENT;TOPICAL 207695-001 Dec 14, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Anacor Pharms Inc EUCRISA crisaborole OINTMENT;TOPICAL 207695-001 Dec 14, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Anacor Pharms Inc EUCRISA crisaborole OINTMENT;TOPICAL 207695-001 Dec 14, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Anacor Pharms Inc EUCRISA crisaborole OINTMENT;TOPICAL 207695-001 Dec 14, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Anacor Pharms Inc EUCRISA crisaborole OINTMENT;TOPICAL 207695-001 Dec 14, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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

Country Patent Number Title Estimated Expiration
Russian Federation 2414906 БОРСОДЕРЖАЩИЕ МАЛЫЕ МОЛЕКУЛЫ (BORON-CONTAINING SMALL MOLLECULES) See Plans and Pricing
Slovenia 2719388 See Plans and Pricing
Hungary E026021 See Plans and Pricing
China 106008571 含硼的小分子 (Boron-containing small molecules) See Plans and Pricing
Hungary E044941 See Plans and Pricing
Denmark 2719388 See Plans and Pricing
European Patent Office 1988779 PETITES MOLECULES CONTENANT DU BORE EN TANT QU'AGENTS ANTI-INFLAMMATOIRES (BORON-CONTAINING SMALL MOLECULES AS ANTI-INFLAMMATORY AGENTS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for crisaborole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2343304 C202030031 Spain See Plans and Pricing 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 20C1024 France See Plans and Pricing PRODUCT NAME: CRISABOROLE, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/19/1421 20200401
2343304 2090017-1 Sweden See Plans and Pricing PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/19/1421 20200401
2343304 2020C/531 Belgium See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: CRISABOROLE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1421 20200401
2343304 LUC00157 Luxembourg See Plans and Pricing 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 132020000000082 Italy See Plans and Pricing PRODUCT NAME: CRISABOROLO, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(STAQUIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1421, 20200401
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.