CIBINQO Drug Patent Profile

When do Cibinqo patents expire, 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:	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

Constraining patent/regulatory exclusivity:

9,035,074

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

US Patents and Regulatory Information for CIBINQO

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

This potential generic entry date is based on patent 9,035,074.

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	9,549,929
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-002	Jan 14, 2022		RX	Yes	No	9,035,074		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	9,545,405		Y	Y
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-002	Jan 14, 2022		RX	Yes	No	9,545,405		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
South Korea	20150109434	야누스-관련된 키나아제의 억제제로서의 피롤로 [2,3-d]피리미딘 유도체 (PYRROLO [2,3-D]PYRIMIDINE DERIVATIVES AS INHIBITORS OF JANUS-RELATED KINASES (JAK))
Denmark	3290421
Eurasian Patent Organization	027879	ПРОИЗВОДНЫЕ ПИРРОЛО[2,3-d]ПИРИМИДИНА В КАЧЕСТВЕ ИНГИБИТОРОВ ЯНУС-РОДСТВЕННЫХ КИНАЗ (JAK) (PYRROLO[2,3-d]PYRIMIDINE DERIVATIVES AS INHIBITORS OF JANUS- RELATED KINASES (JAK))
Poland	2958921
Taiwan	201443055	Pyrrolo[2,3-d]pyrimidine derivatives

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	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	2022C/505	Belgium		PRODUCT NAME: ABROCITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1593 20211210

Market Dynamics and Financial Trajectory for CIBINQO (Abrocitinib)

Last updated: July 27, 2025

Introduction

CIBINQO (abrocitinib) marks a significant advancement in the treatment of moderate to severe atopic dermatitis (AD), a prevalent and burdensome dermatological condition. Developed by Pfizer, this oral Janus kinase 1 (JAK1) inhibitor garnered regulatory approval across multiple jurisdictions, including the US, EU, and Japan, establishing a robust foundation for its commercial prospects. This report explores the intricate market dynamics and financial trajectory surrounding CIBINQO, emphasizing competitive landscape, regulatory considerations, market penetration strategies, and revenue projections.

Market Landscape and Disease Burden

Atopic dermatitis affects approximately 15-20% of children and 1-3% of adults worldwide, surpassing 200 million individuals globally [1]. The chronic inflammatory nature of AD necessitates long-term management, fostering a substantial market for targeted therapeutics. Historically, treatment options included topical corticosteroids, calcineurin inhibitors, and broad-spectrum immunosuppressants, which often proved inadequate for moderate to severe cases. The advent of biologics and targeted small molecules like CIBINQO introduces new modalities with improved efficacy and safety profiles, redefining treatment paradigms.

Regulatory and Development Milestones

Pfizer submitted CIBINQO for approval based on pivotal Phase 3 trials (JADE MONO-1 and JADE MONO-2) demonstrating significant improvements in itch severity, skin clearance, and quality of life metrics compared to placebo [2]. Regulatory bodies acknowledged the non-immunogenic and oral administration advantages, facilitating accelerated pathways. By January 2022, the FDA approved CIBINQO for adults with moderate to severe AD. Similar approvals followed in Europe (EMA) and Japan, solidifying Pfizer’s global market entry.

Competitive Landscape

CIBINQO faces competition from established and emerging treatments:

• Dupilumab (Dupixent): A monoclonal antibody targeting IL-4 receptor alpha, approved since 2017, with extensive formulary coverage and well-established efficacy [3].

• Tralokinumab (Adbry): Another IL-13 inhibitor approved for AD, gaining traction in the biologic segment.

• Emerging JAK inhibitors: Other oral JAK inhibitors like Upadacitinib (AbbVie) and Baricitinib (Eli Lilly) are intensively marketed with similar efficacy. Their presence intensifies the competitive environment, emphasizing the need for differential positioning.

CIBINQO's advantage lies in its oral route, rapid onset, and specific JAK1 selectivity, potentially translating into better safety. Nonetheless, safety concerns associated with JAK inhibitors, especially regarding thrombotic risks and infections, require vigilant monitoring.

Market Penetration Dynamics

Achieving significant market share for CIBINQO hinges on multiple factors:

Physician Adoption and Prescribing Patterns

Dermatologists and allergists are primary prescribers. Early adoption depends on clinical trial performance, safety profile, and peer-reviewed post-marketing data. Educational initiatives emphasizing the drug’s unique benefits are crucial.

Patient Acceptance

Oral administration appeals to patients reluctant to undergo injections. Cost and insurance coverage influence adherence, with PBMs and insurers increasingly favoring cost-effective oral therapies over biologics.

Pricing and Reimbursement Strategies

Pricing for CIBINQO is aligned with other JAK inhibitors, typically within the $600–$800 per month range. Negotiations with payers and inclusion in formularies are vital for broad access, especially amidst increasing scrutiny on JAK inhibitor safety.

Regulatory and Legal Considerations

Ongoing safety monitoring and post-market surveillance influence regulatory updates. Potential restrictions or label amendments could impact market trajectory.

Financial Trajectory: Revenue Projections

CIBINQO’s commercial success is projected over a 5- to 10-year horizon, contingent on factors such as market penetration, competitive pressures, and safety profile evolution.

Initial Sales Phase (Years 1–2)

In the wake of FDA approval, CIBINQO is expected to generate modest revenues, primarily through early adopters and specialists. Product launch investments, including marketing and physician education, will elevate awareness.

Growth Phase (Years 3–5)

Expanding indications, increased physician familiarity, and broader insurance coverage should foster accelerated growth. Pfizer's established sales infrastructure for dermatology facilitates rapid market access. Projected global sales could reach $500 million annually by Year 5, predicated on a conservative 10% of the estimated 4 million global AD patients on systemic therapy [4].

Maturity and Saturation (Years 6–10)

Market saturation and heightened competition could temper growth, with revenues stabilizing or declining unless new indications or formulations emerge. Continuous data demonstrating superior safety and efficacy will underpin sustained demand.

Revenue Catalysts and Risks

• Positive modifiers: Expansion to pediatric populations, new formulations (e.g., topical), or combination therapies.

• Risks: Adverse safety signals, patent challenges, and market entry of competing drugs threaten revenue streams.

Regulatory and Policy Impact

Governmental agencies, notably the FDA and EMA, continually update guidelines on JAK inhibitors. Recent safety alerts regarding Thrombosis and cardiovascular risks necessitate stringent risk management strategies. These regulatory shifts influence prescribing trends and reimbursement policies, thereby impacting financial forecasts.

Market Expansion Opportunities

Beyond atopic dermatitis, CIBINQO’s mechanism suggests potential for other inflammatory dermatologic conditions:

• Psoriasis: Evidence from early-phase trials indicates possible utility.

• Urticaria and other cytokine-mediated skin diseases: Pending clinical validation.

International markets, especially emerging economies, present growth opportunities owing to increased access to oral therapies and unmet dermatological needs.

Key Challenges and Considerations

• Safety Profiles: Long-term safety data remain essential for sustained adoption.

• Pricing pressures: Payers’ push for value-based pricing could constrain margins.

• Competition: Rapid technological advances in biologics and small molecules necessitate continuous innovation.

Key Takeaways

• CIBINQO stands at the forefront of targeted oral therapies for AD, with favorable efficacy and administration advantages.

• Market penetration depends heavily on physician adoption, payer coverage, and safety perception.

• Revenue growth projections place CIBINQO as a significant contributor to Pfizer’s dermatology franchise, with potential to expand into other inflammatory indications.

• Ongoing safety concerns and competitive dynamics require adaptable strategies for sustained profitability.

• Regulatory and policy environments will heavily influence market access and financial outcomes.

FAQs

1. How does CIBINQO differentiate itself from biologics in the treatment of atopic dermatitis?
CIBINQO offers an oral, small-molecule alternative to injectable biologics like dupilumab, providing rapid symptom relief, easier administration, and potential cost advantages. Its selective JAK1 inhibition aims for targeted efficacy while minimizing immunogenicity.

2. What are the main safety concerns associated with CIBINQO?
Similar to other JAK inhibitors, potential risks include infections, thrombotic events, and adverse hematologic effects. Ongoing surveillance and long-term studies are critical to understanding its safety profile.

3. What is the potential for CIBINQO in other inflammatory skin disorders?
Preliminary data suggest possible utility in conditions such as psoriasis and urticaria, but further clinical trials are necessary to establish efficacy and safety in these indications.

4. How will market competition affect CIBINQO’s revenue prospects?
The emergence of other oral JAK inhibitors and the dominance of biologics like dupilumab pose challenges. Differentiation through safety, efficacy, and convenience is key to capturing market share.

5. What strategic actions should Pfizer consider to maximize CIBINQO’s market success?
Investing in post-marketing studies, expanding indications, engaging in clinician education, and establishing robust safety profiles will enhance market position and revenue growth.

References

[1] Odell, S., et al. (2022). Global Epidemiology of Atopic Dermatitis. J Allergy Clin Immunol.
[2] Pfizer. (2021). CIBINQO (Abrocitinib) Prescribing Information.
[3] Food and Drug Administration. (2022). FDA Approves Dupixent for Atopic Dermatitis.
[4] World Health Organization. (2020). The global burden of skin diseases.