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*:
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
Sponsor | Phase |
---|---|
Sun Yat-sen University | Phase 2 |
University of Colorado, Denver | Phase 2 |
Boston University | Phase 4 |
Pharmacology for CRISABOROLE
Drug Class | Phosphodiesterase 4 Inhibitor |
Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 | 8,168,614*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Anacor Pharms Inc | EUCRISA | crisaborole | OINTMENT;TOPICAL | 207695-001 | Dec 14, 2016 | RX | Yes | Yes | 8,501,712*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Anacor Pharms Inc | EUCRISA | crisaborole | OINTMENT;TOPICAL | 207695-001 | Dec 14, 2016 | RX | Yes | Yes | 8,039,451*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Anacor Pharms Inc | EUCRISA | crisaborole | OINTMENT;TOPICAL | 207695-001 | Dec 14, 2016 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Anacor Pharms Inc | EUCRISA | crisaborole | OINTMENT;TOPICAL | 207695-001 | Dec 14, 2016 | RX | Yes | Yes | 9,682,092*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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 |
---|---|---|---|
Luxembourg | C00157 | ⤷ Subscribe | |
Poland | 1853251 | ⤷ Subscribe | |
Australia | 2010203096 | Boron-containing small molecules | ⤷ Subscribe |
Portugal | 2719388 | ⤷ Subscribe | |
Russian Federation | 2016145916 | БОРСОДЕРЖАЩИЕ МАЛЫЕ МОЛЕКУЛЫ | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CRISABOROLE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2343304 | 2020C/531 | Belgium | ⤷ Subscribe | PRODUCT NAME: CRISABOROLE, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1421 20200401 |
2343304 | 20C1024 | France | ⤷ Subscribe | PRODUCT NAME: CRISABOROLE, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/19/1421 20200401 |
2343304 | C20200027 00352 | Estonia | ⤷ Subscribe | PRODUCT NAME: KRISABOROOL;REG NO/DATE: EU/1/19/1421 01.04.2020 |
2343304 | 301049 | Netherlands | ⤷ Subscribe | PRODUCT NAME: CRISABOROLE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1421 20200401 |
2343304 | LUC00157 | Luxembourg | ⤷ Subscribe | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
CRISABOROLE Market Analysis and Financial Projection Experimental
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