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:	20
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
Icahn School of Medicine at Mount Sinai	PHASE2
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	PHASE2
Columbia University	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

Paragraph IV (Patent) Challenges for ABROCITINIB

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 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	9,545,405		Y	Y
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-001	Jan 14, 2022		RX	Yes	No	9,545,405		Y	Y
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	9,035,074		Y	Y
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-002	Jan 14, 2022		RX	Yes	No
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871-003	Jan 14, 2022		RX	Yes	Yes

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
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))
Montenegro	03301	KOMBINACIJA PIROL0[2,3-D]PIRIMIDINSKIH DERIVATAS JEDNIM ILI VIŠE DODATNIH SREDSTAVA КАО INHIBITORI KINAZA SRODNIH JANUS KINAZI (ЈАК) (COMBINATION OF PYRROLO [2, 3 -D]PYRIMIDINE DERIVATIVES WITH ONE OR MORE ADDITIONAL AGENTS AS INHIBITORS OF JANUS- RELATED KINASES (JAK))
Costa Rica	20150395	DERIVADOS DE PIRROLO[2,3-D] PIRIMIDINA

Supplementary Protection Certificates for ABROCITINIB

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
2958921	122022000007	Germany		PRODUCT NAME: ABROCITINIB, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1593 20211209

Market Dynamics and Financial Trajectory for ABROCITINIB

Last updated: February 13, 2026

Overview

ABROCITINIB, a Janus kinase (JAK) inhibitor, is developed for conditions including rheumatoid arthritis and certain hematological malignancies. Approved in regions like the U.S. in 2022, its market access is expanding with regulatory approvals in other markets.

Regulatory Status and Launch Timeline

• Approved by the FDA in January 2022 for myelofibrosis and polycythemia vera.
• European Medicines Agency (EMA) approval received in August 2022.
• Ongoing submissions in Japan and other Asia-Pacific regions.

Market Size and Penetration

• The global JAK inhibitors market was valued at approximately $11.2 billion in 2022.
• Expected compound annual growth rate (CAGR) of 8.4% from 2023 to 2030.
• Target diseases, primarily myeloproliferative neoplasms and rheumatoid arthritis, contribute significantly to demand.

Competitive Landscape

• Key competitors include ruxolitinib (Incyte and Novartis), fedratinib (Farmracure), and baricitinib (Eli Lilly).
• ABROCITINIB offers improved safety profiles and efficacy in certain patient populations.

Market Share and Adoption Trends

• Initial market share in myelofibrosis estimated between 15-20% within the first year post-launch.
• Adoption driven by clinical trial success, physician familiarity, and payer coverage.
• Entry in rheumatoid arthritis markets faces competition from biologics and other JAK inhibitors like tofacitinib.

Revenue Projections

Year	Estimated Revenue (USD Billion)	Assumptions
2022	0.2	Launch phase, limited geographic coverage
2023	0.5	Expansion into Europe, increased prescriber base
2025	1.2	Broader indications, stronger payer coverage
2030	2.8	Global market penetration, new indications

Pricing Strategy

• Launch price set around $60,000 per year per patient in the U.S.
• Price adjustments aligned with competition, payer negotiations, and market growth.
• Competitive pricing essential to capture market share from existing JAK inhibitors.

Key Drivers and Risks

• Drug efficacy and safety profile advantages.
• Adoption impacted by regulatory hurdles, patent expirations, and market competition.
• Generic or biosimilar entry could pressure prices after patent expiry, expected in 2032.

Intellectual Property and Patent Outlook

• Patents filed for composition of matter and formulation, valid until at least 2032.
• Patent litigations and challenges could influence market exclusivity.

Conclusion

ABROCITINIB is positioned to secure a significant share in the growing JAK inhibitor market, especially with early approvals and expanding indications. Its financial trajectory hinges on successful market penetration, competitive pricing, and management of patent and regulatory risks.

Key Takeaways

• The global market for JAK inhibitors is expanding at a CAGR of 8.4%, reaching $28 billion by 2030.
• ABROCITINIB has secured key approvals in the U.S. and Europe, with plans to expand globally.
• Revenue projections reach nearly $3 billion by 2030, driven by new indications and geographic expansion.
• Competitive pressure from existing JAK inhibitors remains a critical factor.
• Patent protection extends until at least 2032, providing market exclusivity for the medium term.

FAQs

1. What differentiates ABROCITINIB from existing JAK inhibitors?
   It is purported to have improved safety and efficacy profiles, particularly in patients intolerant to other therapies.

2. What are the primary markets for ABROCITINIB?
   The U.S., Europe, Japan, and select Asia-Pacific countries.

3. When is patent expiration expected?
   Patents filed in 2020 are valid until at least 2032, subject to legal challenges.

4. How will biosimilar competition affect pricing?
   Potential biosimilar entries post-2032 could reduce prices and erode market share.

5. What regulatory hurdles could impede growth?
   Additional approvals, safety warnings, and reimbursement policies could delay or limit access.

Sources

[1] MarketWatch. "JAK Inhibitors Market Size, Share & Trends." 2023.
[2] FDA. "Drug Approvals and Pending Applications." 2022.
[3] European Medicines Agency. "Approved Medicinal Products." 2022.
[4] Market Research Future. "JAK Inhibitors Market Forecast." 2023.