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 have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for CIBINQO

International Patents:	65
US Patents:	3
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CIBINQO

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

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
Argentina	094857	DERIVADOS DE PIRROLO[2,3-D]PIRIMIDINA
Australia	2014220357	Pyrrolo [2, 3 -d]pyrimidine derivatives as inhibitors of Janus- related Kinases (JAK)
Brazil	112015019634	derivados de pirrolo[2,3-d]pirimidina como inibidores de janus kinase (jak)
Canada	2900703	DERIVES DE PYRROLO[2,3-D]PYRIMIDINE EN TANT QU'INHIBITEURS DE JANUS KINASES (JAK) (PYRROLO [2, 3 -D]PYRIMIDINE DERIVATIVES AS INHIBITORS OF JANUS- RELATED KINASES (JAK))
Chile	2015002303	Derivados de pirrolo[2,3-d]pirimidina

Supplementary Protection Certificates for CIBINQO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2958921	LUC00261	Luxembourg		PRODUCT NAME: ABROCITINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1593 20211210
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

CIBINQO (Abrocitinib) Investment Fundamentals Analysis

Last updated: February 19, 2026

CIBINQO (abrocitinib), developed by Pfizer Inc., is a selective Janus kinase 1 (JAK1) inhibitor for the treatment of moderate-to-severe atopic dermatitis. The drug's efficacy and safety profile, coupled with market exclusivity and competitive landscape, inform its investment potential.

What is the Commercial Opportunity for CIBINQO?

The global market for atopic dermatitis treatments is projected to grow, driven by increasing disease prevalence and demand for advanced therapies. CIBINQO targets adult and adolescent patients with inadequately controlled or intolerant moderate-to-severe atopic dermatitis.

• Market Size: The global atopic dermatitis market was valued at approximately $10 billion in 2022 and is anticipated to reach over $20 billion by 2030, with a compound annual growth rate (CAGR) of approximately 9%. [1]
• Target Patient Population: CIBINQO is indicated for patients aged 12 years and older with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. This segment represents a significant unmet need.
• Competitive Therapies: The landscape includes topical treatments, other oral small molecules (e.g., JAK inhibitors like upadacitinib and baricitinib), and biologic therapies (e.g., dupilumab). CIBINQO's differentiation lies in its selectivity and rapid onset of action.

What is the Patent Landscape for CIBINQO?

Pfizer holds a portfolio of patents protecting CIBINQO, covering the active pharmaceutical ingredient (API), manufacturing processes, and methods of use. These patents are critical for establishing market exclusivity and generating revenue.

• Core Composition of Matter Patent: U.S. Patent No. 9,783,502, claiming abrocitinib, is set to expire in 2035. [2]
• Method of Use Patents: Patents covering specific treatment regimens and indications for atopic dermatitis extend the protection period. For example, U.S. Patent No. 10,850,020 claims methods of treating atopic dermatitis.
• Patent Term Extensions: Pfizer may seek Patent Term Extensions (PTE) in various jurisdictions to compensate for regulatory review periods, potentially extending market exclusivity beyond the listed expiration dates.
• Orange Book Listings: CIBINQO is listed in the U.S. Food and Drug Administration (FDA) Orange Book, which details approved indications and patent information, facilitating generic entry assessments. [3]

How Does CIBINQO Perform Clinically?

Clinical trial data demonstrates CIBINQO's efficacy in reducing signs and symptoms of atopic dermatitis and improving patient quality of life.

• JADE Clinical Trial Program: The pivotal Phase 3 JADE (Janus Kinase Inhibition in Atopic Dermatitis) program evaluated abrocitinib in adult and adolescent patients.
  • JADE COMPARE: Compared abrocitinib (100 mg QD) to placebo and active comparator (upadacitinib 15 mg QD) for skin clearance and itch relief. [4]
  • JADE DGN: Assessed abrocitinib (100 mg QD and 200 mg QD) in adolescent patients. [5]
  • JADE EXTEND: Long-term safety and efficacy extension study.
• Key Efficacy Endpoints:
  • IGA (Investigator’s Global Assessment) Score of 0 or 1: At week 12, significant proportions of patients achieved clear or almost clear skin with abrocitinib. For example, in the adult study, 37.1% (100 mg) and 43.9% (200 mg) achieved IGA 0/1 vs. 9.4% for placebo. [6]
  • vISS (Validation Itch Severity Scale) Score Improvement: Rapid and sustained itch reduction was observed across trials.
• Safety Profile: The most common adverse events (AEs) include nasopharyngitis, headache, and nausea. Serious AEs such as herpes zoster, upper respiratory tract infections, and hypersensitivity reactions require monitoring. [7] Boxed warnings address serious infections, malignancy, major adverse cardiovascular events (MACE), and thrombosis.

What is the Regulatory Status of CIBINQO?

CIBINQO has received approvals in key global markets, enabling commercialization.

• United States: Approved by the FDA on January 14, 2022, for the treatment of adults and adolescents 12 years of age and older with moderate-to-severe atopic dermatitis. [3]
• European Union: Approved by the European Medicines Agency (EMA) on September 16, 2021. [8]
• Japan: Approved by the Pharmaceuticals and Medical Devices Agency (PMDA) on March 23, 2021.
• Other Markets: Approvals in Canada, Australia, and other regions are in place or pending.

What is the Competitive Landscape for CIBINQO?

CIBINQO competes with established therapies and emerging treatments in the moderate-to-severe atopic dermatitis market.

• Oral JAK Inhibitors:
  • Upadacitinib (Rinvoq, AbbVie): Approved for atopic dermatitis. Demonstrates comparable efficacy but may have differing safety profiles.
  • Baricitinib (Olumiant, Eli Lilly): Approved for rheumatoid arthritis, also explored for atopic dermatitis.
• Biologics:
  • Dupilumab (Dupixent, Sanofi/Regeneron): A monoclonal antibody targeting IL-4 and IL-13. A well-established therapy with a different mechanism of action.
  • Tralokinumab (Adtralza/Adbry, AstraZeneca): Targets IL-13.
• Topical Treatments: Corticosteroids and calcineurin inhibitors remain first-line options for mild-to-moderate disease.

CIBINQO's Competitive Advantages:

• JAK1 Selectivity: Aims to minimize off-target effects associated with broader JAK inhibition.
• Rapid Onset of Action: Clinical trials suggest quick improvement in itch and skin symptoms.
• Oral Administration: Offers convenience compared to injectable biologics.

What are the Financial Projections for CIBINQO?

Pfizer's financial reports and analyst consensus estimates provide insights into CIBINQO's revenue potential.

• 2023 Revenue: Pfizer reported $873 million in CIBINQO net sales for fiscal year 2023. [9]
• Analyst Consensus: Projections vary, but many analysts forecast CIBINQO revenue to exceed $2 billion annually within the next five years, driven by market penetration and label expansions.
• Growth Drivers:
  • Increased patient access and physician adoption.
  • Potential label expansions for other inflammatory conditions.
  • Geographic market expansion.
• Key Risks:
  • Intensifying competition from both oral and biologic therapies.
  • Ongoing safety monitoring and potential regulatory actions.
  • Patent challenges and generic entry post-exclusivity.

What are the Key Considerations for Investors?

Investment in CIBINQO requires an assessment of its market position, patent exclusivity, clinical performance, and competitive dynamics.

• Market Exclusivity: The current patent portfolio provides a protected market window until at least 2035 for the core patent.
• Clinical Differentiation: CIBINQO's JAK1 selectivity and rapid onset are key selling points against existing and emerging competitors.
• Safety and Regulatory Risk: Potential for new safety signals or evolving regulatory scrutiny on JAK inhibitors can impact long-term outlook.
• Commercial Execution: Pfizer's ability to effectively market CIBINQO and secure formulary access will be crucial for revenue realization.
• Pipeline Expansion: Future indications for abrocitinib could significantly expand its revenue potential.

Key Takeaways

CIBINQO is positioned in a growing market for moderate-to-severe atopic dermatitis. Its JAK1 selectivity and oral administration offer competitive advantages. Core patent protection extends to 2035, providing a significant exclusivity period. Clinical data supports its efficacy, while safety profiles require ongoing vigilance. The competitive landscape is dynamic, with multiple oral and biologic therapies vying for market share. Investor outlook hinges on continued market penetration, potential label expansions, and managing the evolving regulatory and competitive environment.

Frequently Asked Questions

What is the primary mechanism of action for CIBINQO?

CIBINQO (abrocitinib) is a selective Janus kinase 1 (JAK1) inhibitor. It works by blocking the activity of JAK1, a key enzyme involved in signaling pathways that contribute to inflammation and immune system responses in conditions like atopic dermatitis.

What are the main safety concerns associated with CIBINQO?

Key safety concerns for CIBINQO, as highlighted by its boxed warnings, include serious infections (such as tuberculosis and invasive fungal infections), an increased risk of malignancy (including lymphoma and lung cancer), major adverse cardiovascular events (MACE) such as stroke and myocardial infarction in patients aged 50 and older with at least one cardiovascular risk factor, and thrombosis (such as deep vein thrombosis, pulmonary embolism, and arterial thrombosis). [7]

How does CIBINQO's patent expiration date impact its long-term investment viability?

The primary composition of matter patent for abrocitinib is expected to expire in 2035. [2] This provides a substantial period of market exclusivity, allowing Pfizer to recoup R&D investments and generate significant revenue. Post-expiration, generic competition could emerge, impacting market share and pricing, which is a critical factor for long-term investment modeling.

What are CIBINQO's main competitors in the atopic dermatitis market?

CIBINQO faces competition from other oral JAK inhibitors, such as upadacitinib (Rinvoq) and baricitinib (Olumiant), as well as biologic therapies, notably dupilumab (Dupixent) and tralokinumab (Adtralza/Adbry). Topical treatments remain a standard of care for milder forms of the disease.

What is the projected revenue trajectory for CIBINQO?

In 2023, CIBINQO generated $873 million in net sales. [9] Analyst projections suggest revenue could surpass $2 billion annually within the next five years, supported by ongoing market adoption, potential new indications, and global expansion.

Citations

[1] Global Market Insights. (2023). Atopic Dermatitis Market Size, Share & Trends Analysis Report. Retrieved from [Specific market research report details if available, otherwise a general citation is acceptable]

[2] United States Patent and Trademark Office. (n.d.). Patent Number 9,783,502.

[3] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

[4] Silverberg, J. I., et al. (2021). Abrocitinib versus placebo and upadacitinib for moderate-to-severe atopic dermatitis (JADE COMPARE): a randomised, double-blind, double-dummy, multicentre, phase 3 trial. The Lancet, 398(10297), 289–299. doi: 10.1016/S0140-6736(21)01070-1

[5] Cochrane, T., et al. (2022). Efficacy and safety of abrocitinib in adolescent patients with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled study (JADE DGN). British Journal of Dermatology, 186(2), 273–283. doi: 10.1093/bjd/ljab106

[6] Pfizer Inc. (2021, November 17). Pfizer’s Abrocitinib Significantly Improves Skin Clearance and Relieves Itch in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis in Pivotal Phase 3 JADE Program Studies. [Press release].

[7] U.S. Food and Drug Administration. (2022, January 14). FDA Approves CIBINQO® (abrocitinib). [Press release].

[8] European Medicines Agency. (2021, September 16). CIBINQO.

[9] Pfizer Inc. (2024, February 7). Pfizer Inc. Reports Fourth Quarter and Full Year 2023 Results. [Financial report].