Abrocitinib - Generic Drug Details

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What are the generic sources for abrocitinib and what is the scope of patent protection?

Abrocitinib is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Abrocitinib has sixty-five patent family members in forty-four countries.

Two suppliers are listed for this compound.

Summary for abrocitinib

International Patents:	65
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	14
Patent Applications:	115
What excipients (inactive ingredients) are in abrocitinib?	abrocitinib excipients list
DailyMed Link:	abrocitinib at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for abrocitinib

Generic Entry Date for abrocitinib^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL

^*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 abrocitinib

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

Sponsor	Phase
Peng Zhang	Early Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2
William Damsky	Phase 2

See all abrocitinib clinical trials

Pharmacology for abrocitinib

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for abrocitinib

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

US Patents and Regulatory Information for abrocitinib

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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
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-003	Jan 14, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-001	Jan 14, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-003	Jan 14, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-002	Jan 14, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-003	Jan 14, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-002	Jan 14, 2022		RX	Yes	No	⤷ 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 abrocitinib

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Cibinqo	abrocitinib	EMEA/H/C/005452 Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.	Authorised	no	no	no	2021-12-09
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for abrocitinib

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Country	Patent Number	Title	Estimated Expiration
Moldova, Republic of	20150073	Derivaţi ai pirolo[2,3-d]pirimidinei ca inhibitori de Kinaze Janus-asociate (JAK)	⤷ Sign Up
Japan	2017165762	ヤヌス関連キナーゼ（ＪＡＫ）の阻害剤としてのピロロ［２，３−ｄ］ピリミジン誘導体 (PYRROLO [2,3-D]PYRIMIDINE DERIVATIVES AS INHIBITORS OF JANUS- RELATED KINASES (JAK))	⤷ Sign Up
Slovenia	3290421		⤷ Sign Up
South Africa	201505454	PYRROLO [2, 3 -D]PYRIMIDINE DERIVATIVES AS INHIBITORS OF JANUS- RELATED KINASES (JAK)	⤷ Sign Up
Moldova, Republic of	4735	Derivaţi ai pirolo[2,3-d]pirimidinei ca inhibitori de Kinaze Janus-asociate (JAK) (Pyrrolo[2,3-d]pyrimidine derivatives as inhibitors of Janus-related Kinases (JAK))	⤷ Sign Up
Hong Kong	1213881	作為詹納斯相關激酶抑制劑的吡咯並嘧啶衍生物 (PYRROLO [2, 3 -D] PYRIMIDINE DERIVATIVES AS INHIBITORS OF JANUS- RELATED KINASES (JAK) (JAK)[23-D])	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for abrocitinib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2958921	122022000007	Germany	⤷ Sign Up	PRODUCT NAME: ABROCITINIB, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1593 20211209
2958921	LUC00261	Luxembourg	⤷ Sign Up	PRODUCT NAME: ABROCITINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1593 20211210
2958921	PA2022502	Lithuania	⤷ Sign Up	PRODUCT NAME: ABROCITINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/21/1593 20211209
2958921	CA 2022 00003	Denmark	⤷ Sign Up	PRODUCT NAME: ABROCITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1593 20211210
2958921	301155	Netherlands	⤷ Sign Up	PRODUCT NAME: ABROCITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: PLGB 00057/1703-1705 20210908
2958921	2022C/505	Belgium	⤷ Sign Up	PRODUCT NAME: ABROCITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1593 20211210
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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