ABROCITINIB - Generic Drug Details

What are the generic drug 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:	18
What excipients (inactive ingredients) are in ABROCITINIB?	ABROCITINIB excipients list
DailyMed Link:	ABROCITINIB at DailyMed

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

Constraining patent/regulatory exclusivity:

9,035,074

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
Pfizer	PHASE3
Beth Israel Deaconess Medical Center	PHASE2
Pfizer	PHASE2

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

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	9,035,074		Y	Y
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-003	Jan 14, 2022		RX	Yes	Yes
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-003	Jan 14, 2022		RX	Yes	Yes	9,549,929
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-002	Jan 14, 2022		RX	Yes	No	9,545,405		Y	Y

EU/EMA Drug Approvals for ABROCITINIB

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 ABROCITINIB

Country	Patent Number	Title	Estimated Expiration
Portugal	2958921
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
New Zealand	710411	Pyrrolo [2, 3 -d]pyrimidine derivatives as inhibitors of janus- related kinases (jak)
Cyprus	1119502

Supplementary Protection Certificates for ABROCITINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2022C/505	Belgium		PRODUCT NAME: ABROCITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND 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

Market Dynamics and Financial Trajectory for Abrocitinib

Last updated: July 28, 2025

Introduction

Abrocitinib is an oral Janus kinase (JAK) inhibitor developed by Pfizer for the treatment of moderate to severe atopic dermatitis (AD). Approved by the U.S. Food and Drug Administration (FDA) in 2021 under the brand name Cibinqo, it has rapidly attracted attention within dermatology and immunology markets. This article analyzes the evolving market dynamics and financial trajectory of abrocitinib, considering current competitive landscapes, regulatory factors, pipeline developments, and market adoption trends.

Market Landscape and Therapeutic Need

Atopic dermatitis affects approximately 10-20% of children and 1-3% of adults globally, posing significant economic and quality-of-life burdens. Traditional treatments, including topical steroids and systemic immunosuppressants, often fail to control severe cases and are associated with adverse side effects. Biologics like dupilumab, introduced in 2017, have set new standards but face limitations in cost and administration routes.

The necessity for targeted oral therapies positions abrocitinib as a potent candidate to address unmet medical needs, especially among patients seeking oral formulations and rapid onset of action.

Market Dynamics

Competitive Landscape

Abrocitinib enters a competitive sphere comprising both biologics and emerging oral JAK inhibitors. Key competitors include:

• Dupilumab (Dupixent): A monoclonal antibody targeting IL-4Rα, dominant since 2017, with a substantial market share.
• Upadacitinib (Rinvoq): An oral JAK1 inhibitor launched by AbbVie, approved for atopic dermatitis in 2021.
• Baricitinib (Olumiant): Another oral JAK inhibitor, approved for rheumatoid arthritis and recently for AD.
• Other emerging JAK inhibitors: Filgotinib and tofacitinib, under investigation or off-label use.

This competitive environment drives strategic positioning for abrocitinib, aiming for differentiation via efficacy, safety, and convenience.

Regulatory and Reimbursement Factors

Abrocitinib’s accelerated approval by the FDA underscores recognition of its clinical promise. However, reimbursement considerations significantly influence market adoption:

• Pricing Strategies: Pfizer’s initial pricing aligns with biologics, potentially limiting uptake among cost-sensitive payers.
• Coverage Policies: Payers may favor established biologics unless convincing comparative superiority or cost-effectiveness data emerge.
• Global Regulatory Status: While approved in the U.S., approvals in EU, Japan, and emerging markets will dictate regional sales trajectories.

Market Penetration and Adoption Trends

Post-approval, adoption rates have accelerated due to:

• Physician awareness driven by clinical trial data demonstrating rapid symptom relief.
• Patient preference for oral administration over injectable biologics.
• Positive pharmacovigilance data confirming safety profiles comparable to existing JAK inhibitors.

Sales momentum, however, faces initial slow uptake due to conservative prescribing patterns, especially outside of specialty dermatology centers.

Clinical Data and Label Expansion

Ongoing phase 3 studies and real-world evidence reports are critical for:

• Label extension for other indications such as chronic pruritus and other inflammatory dermatologic conditions.
• Comparative efficacy evaluations against peers to establish superiority or niche positioning.

Successful demonstration of broad-spectrum efficacy and minimal adverse effects will bolster market share.

Financial Trajectory

Revenue Projections

Pfizer’s 2022 financial disclosures projected peak sales of approximately $1 billion within 3-5 years post-launch, contingent on:

• Market penetration rates
• Pricing adjustments
• Global expansion strategies

Initial sales are likely to be modest, with a gradual uptick as additional indications are pursued and accumulating real-world experience supports broader usage.

Pricing and Market Access

AbbVie’s pricing for Upadacitinib ranged between $50–$60 per dose, with potential discounts to secure formulary coverage. Pfizer is expected to adopt similar strategies, balancing profitability with market access.

Investment in Manufacturing and Supply Chain

To meet growing demand, Pfizer has committed to scaling manufacturing, ensuring supply chain robustness—a crucial factor in capturing downstream revenue.

Pipeline and Future Opportunities

Beyond atopic dermatitis, Pfizer explores abrocitinib’s utility in:

• Autoimmune diseases such as chronic psoriasis.
• Rheumatological conditions when supported by clinical data.

Any successful expansion can significantly enhance the drug’s revenue prospects.

Risks and Challenges

• Market saturation could limit growth.
• Competitive innovations may erode market share.
• Regulatory hurdles in new jurisdictions.
• Safety concerns, especially infection risks associated with JAK inhibitors, could impact adoption.

Conclusion

Abrocitinib represents a significant advancement in oral immunomodulators for atopic dermatitis, with strong market potential driven by unmet clinical needs, oral administration convenience, and Pfizer’s robust commercial capabilities. Its financial trajectory will depend on overcoming competitive pressures, regulatory navigation, and successful demonstration of cost-effectiveness.

Key Takeaways

• Growth potential remains high, contingent upon market access and positioning against established biologics and competing JAK inhibitors.
• Strategic pricing and reimbursement negotiations will be pivotal; early demonstration of cost-effectiveness will accelerate uptake.
• Pipeline developments for expanded indications could materially boost sales.
• Global regulatory approvals are critical to capturing emerging markets’ revenue streams.
• Safety profile monitoring will influence long-term market sustainability, particularly in populations with comorbid conditions.

FAQs

1. How does abrocitinib differ from other JAK inhibitors in the treatment of atopic dermatitis?
Abrocitinib specifically inhibits JAK1, similar to upadacitinib, offering rapid symptom relief and oral administration. Its differentiated profile includes once-daily dosing and favorable safety data, which can appeal to patients seeking alternatives to biologics.

2. What are the primary barriers to abrocitinib’s market penetration?
Major barriers include existing dominance by biologics like dupilumab, payer preference for established treatments, high pricing, and cautious prescribing due to safety concerns associated with JAK inhibitors.

3. What is the potential for off-label use of abrocitinib?
Off-label use may include other inflammatory skin or autoimmune conditions, but regulatory restrictions and safety profiles limit this. Clinical trials are essential to expand indications officially.

4. How does Pfizer plan to position abrocitinib globally?
Pfizer aims for strategic expansion through regional approvals, tailored pricing, and local partnerships, leveraging its global infrastructure to accelerate availability in Europe, Asia, and emerging markets.

5. What is the outlook for abrocitinib’s competition in the next five years?
With multiple pipeline candidates and increasing head-to-head trials, competition will intensify. Success hinges on demonstrating superior efficacy, safety, and cost advantages, which will define market share dynamics.

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Sources:
[1] FDA Approval Announcement, Pfizer, 2021.
[2] ClinicalTrials.gov, Abrocitinib studies, 2022.
[3] Pfizer Financial Reports, 2022.
[4] Industry Reports on Atopic Dermatitis Market, 2023.
[5] Comparative Analysis of JAK inhibitors, dermatology journals, 2022.