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Last Updated: March 19, 2024

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-seven 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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for crisaborole
Generic Entry Date for crisaborole*:
Constraining patent/regulatory exclusivity:
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

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 ⤷  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 ⤷  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

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

Supplementary Protection Certificates for crisaborole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 CR 2020 00022 Denmark ⤷  Try a Trial PRODUCT NAME: CRISABOROLE, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1421 20200401
2343304 2090017-1 Sweden ⤷  Try a Trial PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: 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.