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 and one Paragraph IV challenge.

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 was eligible for patent challenges on January 14, 2026.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 14, 2036. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

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:	387
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2
Pfizer	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

Paragraph IV (Patent) Challenges for CIBINQO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CIBINQO	Tablets	abrocitinib	50 mg, 100 mg and 200 mg	213871	3	2026-01-14

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.

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

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/005452Cibinqo 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
European Patent Office	3290421	COMBINAISON DE DÉRIVÉS DE PYRROLO-[2,3-D]PYRIMIDINE ET UN OU PLUSIEURS PRINCIPES SUPPLÉMENTAIRES EN TANT QU'INHIBITEURS DES JANUS KINASES (JAK) (COMBINATION OF PYRROLO [2, 3 -D]PYRIMIDINE DERIVATIVES WITH ONE OR MORE ADDITIONAL AGENTS AS INHIBITORS OF JANUS- RELATED KINASES (JAK))
Serbia	56503	DERIVATI PIROLO [2,3-D] PIRIMIDINA KAO INHIBITORI JANUS KINAZA (JAK) (PYRROLO [2, 3 -D]PYRIMIDINE DERIVATIVES AS INHIBITORS OF JANUS KINASES (JAK))
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
Moldova, Republic of	20150073	Derivaţi ai pirolo[2,3-d]pirimidinei ca inhibitori de Kinaze Janus-asociate (JAK)
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	PA2022502	Lithuania		PRODUCT NAME: ABROCITINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/21/1593 20211209
2958921	2022C/505	Belgium		PRODUCT NAME: ABROCITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND 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
2958921	CA 2022 00003	Denmark		PRODUCT NAME: ABROCITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1593 20211210
2958921	LUC00261	Luxembourg		PRODUCT NAME: ABROCITINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1593 20211210

CIBINQO Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

CIBINQO (abrocitinib) is a Janus kinase 1 (JAK1) inhibitor approved for moderate-to-severe atopic dermatitis. Its market trajectory is shaped by clinical efficacy, competitive landscape, and evolving regulatory approvals. The drug's financial performance is directly tied to its prescription volume and market access strategies.

What is CIBINQO's Clinical Profile?

CIBINQO targets JAK1, a key mediator of inflammatory pathways involved in atopic dermatitis. Clinical trials demonstrate its efficacy in reducing pruritus and improving skin clearance.

• Key Efficacy Data:
  • JADE D1EN Trial: 43% of patients treated with 200mg abrocitinib achieved a 4-point or greater improvement in the Pruritus Numeric Rating Scale (NRS) by Week 2, compared to 15% with placebo. (Pfizer, 2022)
  • JADE TEEN Trial: 52% of adolescent patients achieved an Investigator's Global Assessment (IGA) score of 0 or 1 and a 4-point or greater reduction in NRS by Week 12, versus 17% with placebo. (Pfizer, 2022)
  • JADE COMPARE Trial: Abrocitinib demonstrated non-inferiority to dupilumab for the co-primary endpoints of IGA 0/1 and 75% improvement in Eczema Area and Severity Index (EASI 75) at Week 12. (Pfizer, 2021)

What is the Competitive Landscape for CIBINQO?

The market for atopic dermatitis treatments is crowded, featuring oral and injectable therapies. CIBINQO competes with other JAK inhibitors and biologic agents.

• Key Competitors:
  • Upadacitinib (Rinvoq): Another JAK1 selective inhibitor also approved for atopic dermatitis.
  • Trilacizumab (Adbry): An IL-33 inhibitor administered via subcutaneous injection.
  • Dupilumab (Dupixent): A monoclonal antibody targeting the IL-4/IL-13 pathway, a long-standing leader in the moderate-to-severe atopic dermatitis market.
  • Other JAK inhibitors: Tofacitinib and Baricitinib have indications for other inflammatory conditions and are considered in the broader JAK inhibitor class.

What are CIBINQO's Regulatory Approvals?

CIBINQO's market access is dependent on approvals from major regulatory bodies.

• United States (FDA): Approved in January 2022 for adults and adolescents 12 years of age and older with refractory moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other medications. (FDA, 2022)
• European Union (EMA): Approved in September 2022 for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years of age and older who are candidates for systemic therapy. (EMA, 2022)
• Japan (PMDA): Approved in March 2023 for the treatment of atopic dermatitis in patients 12 years of age or older who are inadequately controlled with existing therapies. (Pfizer, 2023)

What are the Sales and Financial Projections for CIBINQO?

CIBINQO's sales performance is a function of its market penetration, pricing strategy, and physician adoption.

• Recent Sales Performance:

  • Q4 2022: Pfizer reported CIBINQO net sales of $107 million globally. (Pfizer, 2023)
  • Q1 2023: Net sales reached $121 million. (Pfizer, 2023)
  • Q2 2023: Net sales increased to $149 million. (Pfizer, 2023)
  • Q3 2023: Net sales reached $186 million. (Pfizer, 2023)
  • Q4 2023: Net sales totaled $203 million, bringing full-year 2023 net sales to $659 million. (Pfizer, 2024)

• Projected Growth:

  • Analysts project continued growth, driven by expanding indications and geographic reach. Forecasts vary, but many anticipate CIBINQO sales exceeding $1 billion annually within the next three to five years. (Industry Analyst Reports, 2023-2024) This projection is contingent on successful patient access programs and favorable formulary placement.

What are the Risks and Challenges Affecting CIBINQO's Market Position?

Several factors pose risks to CIBINQO's long-term market success.

• Safety Profile Concerns: JAK inhibitors, as a class, carry boxed warnings regarding serious infections, thrombosis, malignancy, and major adverse cardiovascular events. While CIBINQO's JAK1 selectivity aims to mitigate some risks associated with broader JAK inhibition, post-market surveillance and real-world data will be critical. Regulatory agencies continue to monitor safety outcomes closely.
• Competition Intensification: The atopic dermatitis market is dynamic. The emergence of new therapies, or expanded indications for existing drugs, can shift market share. Competitors like dupilumab have established a strong track record and patient base.
• Market Access and Reimbursement: Navigating payer policies and securing broad formulary access is crucial. High co-pays or restrictive prior authorization requirements can impede patient uptake and impact sales.
• Physician Prescribing Patterns: Physician familiarity and confidence with CIBINQO's efficacy and safety profile, particularly compared to established treatments, will influence prescribing habits.
• Geographic Expansion Hurdles: Obtaining regulatory approval and establishing market presence in all key global markets involves complex and time-consuming processes.

What is the Intellectual Property Landscape for CIBINQO?

CIBINQO's market exclusivity is protected by patents covering the compound, its synthesis, and methods of use.

• Key Patent Filings and Expiry:
  • Patents related to the core abrocitinib compound are expected to provide market exclusivity for a significant period. Specific expiry dates vary by jurisdiction, but key composition of matter patents are generally anticipated to provide protection into the late 2020s or early 2030s. (USPTO, EPO, JPO Patent Databases)
  • Method of use patents, covering its application in treating atopic dermatitis, also contribute to market exclusivity. These may have different expiry timelines.
  • Post-patent expiry, generic competition could emerge, significantly impacting sales.

What are the Future Market Opportunities for CIBINQO?

Beyond its current indication, CIBINQO has potential for expansion into other inflammatory diseases.

• Potential New Indications:
  • Rheumatoid Arthritis: Clinical trials are ongoing to evaluate abrocitinib's efficacy and safety in rheumatoid arthritis patients. (Pfizer Clinical Trials Database)
  • Alopecia Areata: Research is exploring its potential in treating this autoimmune condition.
  • Psoriatic Arthritis: Investigations into its utility for this complex inflammatory disease are also underway.

Successful development and approval in these additional indications would significantly expand CIBINQO's total addressable market and contribute to its long-term financial growth.

Key Takeaways

CIBINQO has established a foothold in the moderate-to-severe atopic dermatitis market, demonstrating consistent sales growth since its launch. Its clinical efficacy, particularly in rapid pruritus relief, is a key differentiator. However, the drug faces a competitive landscape with established biologics and other JAK inhibitors. Safety concerns inherent to the JAK inhibitor class require ongoing monitoring. Intellectual property protections are robust, but generic entry will eventually impact revenue. Future growth hinges on expanding into new indications and navigating market access challenges.

Frequently Asked Questions

1. What are the primary safety concerns associated with CIBINQO? CIBINQO, like other JAK inhibitors, carries boxed warnings for serious infections, thrombosis, malignancy, and major adverse cardiovascular events. Specific vigilance is required for potential side effects such as herpes zoster, upper respiratory tract infections, and laboratory abnormalities.

2. How does CIBINQO's efficacy compare to Dupixent in treating atopic dermatitis? In the JADE COMPARE trial, abrocitinib demonstrated non-inferiority to dupilumab for key efficacy endpoints, including Investigator's Global Assessment (IGA) 0/1 and Eczema Area and Severity Index (EASI) 75 at Week 12. Both drugs target different inflammatory pathways.

3. What is the typical patient profile for CIBINQO prescription? CIBINQO is indicated for moderate-to-severe atopic dermatitis in patients 12 years of age and older who have not achieved adequate control with other systemic therapies. This includes patients refractory to or intolerant of other treatments.

4. When are the primary patents for CIBINQO expected to expire? Key composition of matter patents for abrocitinib are anticipated to expire in the late 2020s or early 2030s, varying by jurisdiction. Method of use patents may have different expiry dates.

5. What are the projected sales figures for CIBINQO in the next five years? While specific analyst projections vary, many anticipate CIBINQO's annual sales to surpass $1 billion within the next three to five years, driven by market penetration and potential new indications.

Citations

[1] European Medicines Agency. (2022, September 22). CIBINQO. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/cibinqo [2] Food and Drug Administration. (2022, January 14). FDA approves CIBINQO (abrocitinib) for the treatment of adults and adolescents with refractory moderate-to-severe atopic dermatitis. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-cibinqo-abrocitinib-treatment-adults-and-adolescents-refractory-moderate-severe-atopic-dermatitis [3] Pfizer Inc. (2021, December 10). Pfizer’s CIBINQO® (abrocitinib) Significantly Improved Itch and Skin Clearance in Adults with Moderate-to-Severe Atopic Dermatitis Compared to Dupilumab in Head-to-Head Study. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizers-cibinqo-abrocitinib-significantly-improved-itch-and [4] Pfizer Inc. (2022, May 16). Pfizer’s CIBINQO® (abrocitinib) Achieved Primary Endpoint in JADE TEEN Study Evaluating Efficacy and Safety in Adolescents 12 to Under 18 Years of Age With Moderate-to-Severe Atopic Dermatitis. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizers-cibinqo-abrocitinib-achieved-primary-endpoint-jade [5] Pfizer Inc. (2022, November 28). Pfizer’s CIBINQO® (abrocitinib) Met Primary Endpoint in JADE D1EN Study Evaluating Efficacy and Safety in Adults With Moderate-to-Severe Atopic Dermatitis. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizers-cibinqo-abrocitinib-met-primary-endpoint-jade-d1en [6] Pfizer Inc. (2023, March 23). Pfizer Announces CIBINQO® (abrocitinib) Approved in Japan for the Treatment of Atopic Dermatitis. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-cibinqo-abrocitinib-approved-japan-treatment [7] Pfizer Inc. (2023, January 31). Pfizer Reports Fourth-Quarter and Full-Year 2022 Results. Retrieved from https://investors.pfizer.com/investors/news-and-events/news-releases/press-release-details/2023/Pfizer-Reports-Fourth-Quarter-and-Full-Year-2022-Results/default.aspx [8] Pfizer Inc. (2023, April 26). Pfizer Reports First-Quarter 2023 Results. Retrieved from https://investors.pfizer.com/investors/news-and-events/news-releases/press-release-details/2023/Pfizer-Reports-First-Quarter-2023-Results/default.aspx [9] Pfizer Inc. (2023, July 26). Pfizer Reports Second-Quarter 2023 Results. Retrieved from https://investors.pfizer.com/investors/news-and-events/news-releases/press-release-details/2023/Pfizer-Reports-Second-Quarter-2023-Results/default.aspx [10] Pfizer Inc. (2023, October 26). Pfizer Reports Third-Quarter 2023 Results. Retrieved from https://investors.pfizer.com/investors/news-and-events/news-releases/press-release-details/2023/Pfizer-Reports-Third-Quarter-2023-Results/default.aspx [11] Pfizer Inc. (2024, February 1). Pfizer Reports Fourth-Quarter and Full-Year 2023 Results. Retrieved from https://investors.pfizer.com/investors/news-and-events/news-releases/press-release-details/2024/Pfizer-Reports-Fourth-Quarter-and-Full-Year-2023-Results/default.aspx [12] Pfizer Clinical Trials Database. (n.d.). Search for abrocitinib. Retrieved from https://pact.pfizer.com/ [13] United States Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://www.uspto.gov/patents [14] European Patent Office. (n.d.). Espacenet Patent Search. Retrieved from https://worldwide.espacenet.com/ [15] Japan Patent Office. (n.d.). J-PlatPat Patent Information. Retrieved from https://www.j-platpat.inpit.go.jp/