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CIBINQO Drug Patent Profile

Which patents cover Cibinqo, and when can generic versions of Cibinqo launch?

Cibinqo is a drug marketed by Pfizer and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in CIBINQO is abrocitinib. Two suppliers are listed for this compound. Additional details are available on the abrocitinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Cibinqo

Cibinqo will be eligible for patent challenges on January 14, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 19, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CIBINQO

International Patents:	65
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	2
Patent Applications:	38
Drug Prices:	Drug price information for CIBINQO
What excipients (inactive ingredients) are in CIBINQO?	CIBINQO excipients list
DailyMed Link:	CIBINQO at DailyMed

See drug prices for CIBINQO

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

NDA:

213871

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 CIBINQO

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

Sponsor	Phase
Pfizer	Phase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2
Innovaderm Research Inc.	Phase 4

See all CIBINQO clinical trials

Pharmacology for CIBINQO

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

Anatomical Therapeutic Chemical (ATC) Classes for CIBINQO

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

US Patents and Regulatory Information for CIBINQO

CIBINQO is protected by three US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CIBINQO

FDA Regulatory Exclusivity protecting CIBINQO

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

EU/EMA Drug Approvals for CIBINQO

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

International Patents for CIBINQO

When does loss-of-exclusivity occur for CIBINQO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Turkey

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CIBINQO around the world.

Country	Patent Number	Title	Estimated Expiration
Morocco	38347	Dérivés de pyrrolo[2,3-d]pyrimidine en tant qu'inhibiteurs de janus kinases (jak)
European Patent Office	2958921	DÉRIVÉS DE PYRROLO-[2,3-D]PYRIMIDINE EN TANT QU'INHIBITEURS DES JANUS KINASES (JAK) (PYRROLO [2, 3 -D]PYRIMIDINE DERIVATIVES AS INHIBITORS OF JANUS KINASES (JAK))
Denmark	3290421
Cuba	20150078	DERIVADOS DE CICLOALQUILO PIRROLO [2, 3-D]PIRIMIDINA -4-IL AMINO ÚTILES COMO INHIBIDORES DE QUINASAS JANUS RELACIONADAS Y COMPOSICIONES FARMACÉUTICAS QUE CONTIENEN TALES COMPUESTOS
Norway	3052752
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))

Supplementary Protection Certificates for CIBINQO

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