XELJANZ Drug Patent Profile

Which patents cover Xeljanz, and what generic alternatives are available?

Xeljanz is a drug marketed by Pfizer and Pf Prism Cv and is included in three NDAs. There are four patents protecting this drug and three Paragraph IV challenges.

This drug has seventy-five patent family members in fifty-two countries.

The generic ingredient in XELJANZ is tofacitinib citrate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xeljanz

A generic version of XELJANZ was approved as tofacitinib citrate by AJANTA PHARMA LTD on August 19^th, 2025.

Summary for XELJANZ

International Patents:	75
US Patents:	1
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	30
Patent Applications:	998
Drug Prices:	Drug price information for XELJANZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XELJANZ
What excipients (inactive ingredients) are in XELJANZ?	XELJANZ excipients list
DailyMed Link:	XELJANZ at DailyMed

See drug prices for XELJANZ

Recent Clinical Trials for XELJANZ

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Takeda	Phase 4
Children's Hospital Los Angeles	Phase 2
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 4

See all XELJANZ clinical trials

Pharmacology for XELJANZ

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Paragraph IV (Patent) Challenges for XELJANZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XELJANZ	Oral Solution	tofacitinib citrate	1 mg/mL	213082	1	2021-11-12
XELJANZ	Tablets	tofacitinib citrate	10 mg	203214	1	2019-07-24
XELJANZ	Tablets	tofacitinib citrate	5 mg	203214	3	2016-11-07

US Patents and Regulatory Information for XELJANZ

XELJANZ is protected by one US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020		RX	Yes	Yes	RE41783*PED				Y
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018		RX	Yes	Yes	RE41783*PED				Y
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No	RE41783*PED				Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes	10,639,309*PED				Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016	AB	RX	Yes	No	RE41783*PED				Y
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020		RX	Yes	Yes

Expired US Patents for XELJANZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012	7,091,208
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012	7,842,699
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012	6,956,041
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	6,956,041
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012	7,265,221
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018	6,956,041

International Patents for XELJANZ

See the table below for patents covering XELJANZ around the world.

Country	Patent Number	Title	Estimated Expiration
Turkey	200201498
Germany	60239146
Algeria	3248	COMPOSÉS À BASE DE PYRROLO[2,3-D]PYRIMIDINE
Slovakia	14652003	Spôsob optického rozlíšenia (1-benzyl-4-metylpiperidín-3-yl)- metylamínu a jeho použitie a prípravu derivátov pyrol[2,3-d]pyrimidínu, a ich použitie ako inhibítorov proteínkináz (Optical resolution of (1-benzyl-4-methylpiperidin-3-yl)- methylamine and the use thereof for the preparation of pyrrolo 2,3-pyrimidine derivatives as protein kinases inhibitors)
China	1729192
Russian Federation	2004117088

Supplementary Protection Certificates for XELJANZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	C 2017 029	Romania		PRODUCT NAME: TOFACITINIB, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREA CITRAT 3-((3R,4R)-4-METIL-3-{METIL-(7H-PIROLO[2,3-D]PIRIMIDIN-4-IL)-AMINO]PERIDINIL)-3-OXO-PROPIONITRIL; NATIONAL AUTHORISATION NUMBER: EU/1/17/1178; DATE OF NATIONAL AUTHORISATION: 20170322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1178; DATE OF FIRST AUTHORISATION IN EEA: 20170322
1666481	CA 2017 00035	Denmark		PRODUCT NAME: TOFACITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER CITRAT-SALTET; REG. NO/DATE: EU/1/17/1178/001-003 20170324
1666481	122017000062	Germany		PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481	17C1031	France		PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
1666481	2017C/032	Belgium		PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324
1666481	PA2017025	Lithuania		PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322

Market Dynamics and Financial Trajectory for XELJANZ (Upadacitinib)

Last updated: December 30, 2025

Executive Summary

XELJANZ (upadacitinib) has established itself as a leading oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). Since its US FDA approval in August 2019, XELJANZ's market trajectory has been shaped by expanding indications, competitive pressures, and clinical pipeline developments. This comprehensive analysis evaluates its market dynamics, revenue evolution, competitive landscape, regulatory environment, and future prospects, providing essential insights for stakeholders.

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What Are the Key Market Drivers and Challenges for XELJANZ?

Market Drivers

Factor	Impact	Details
Growing RA Prevalence	Increased demand	According to the CDC, approximately 1.3 million Americans suffer from RA, creating a sizable market for effective DMARDs (Disease-Modifying Anti-Rheumatic Drugs).
Expanded Indications	Revenue growth	FDA approvals for psoriatic arthritis (PsA), ulcerative colitis (UC), and atopic dermatitis broaden the application base. As of 2023, XELJANZ is approved for multiple autoimmune conditions.
Oral Administration Format	Patient preference	Oral JAK inhibitors differentiate from injectable biologics, emphasizing convenience and adherence, especially in chronic conditions.
Pipeline Expansion	Future growth	Additional pipeline candidates in clinical trials for diseases like Crohn’s disease and ankylosing spondylitis could further expand sales.
Orphan & Unmet Needs	Market penetration	Need for effective treatments in refractory RA or those intolerant to biologics sustains demand.

Market Challenges

Factor	Impact	Details
Competitive Landscape	Market share erosion	Biologics like Humira (adalimumab), Enbrel (etanercept), and other JAK inhibitors (e.g., Olumiant) compete fiercely.
Pricing Dynamics & Reimbursement Policies	Margin pressures	US and global payers increasingly negotiate drug prices and impose utilization controls.
Safety Concerns & Side Effects	Market hesitancy	Risks such as thrombosis, infections, and cytopenias influence physician prescribing. Regulatory agencies, like the EMA (European Medicines Agency), periodically update warnings.
Generic & Biosimilar Competition	Long-term impact	Though biologics face biosimilars, small-molecule JAK inhibitors like XELJANZ benefit from patent protections till mid-2020s, but biosimilar entry is imminent.

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Financial Trajectory of XELJANZ: Historical and Projected Revenue Analysis

Historical Sales Data (2019-2022)

Year	Global Sales (USD Billion)	Notes
2019	$1.02	Launch year in RA, initial uptake in US and Europe
2020	$1.45	COVID-19 pandemic impacted launches but sales grew gradually
2021	$2.10	Expanded indications (PsA, UC), increased market share
2022	$2.75	Launch in additional markets, pipeline progress

Source: EvaluatePharma, 2023 estimates.

Projected Sales 2023-2027

Year	Projected Global Sales (USD Billion)	Assumptions
2023	$3.45	Continued expansion, pipeline catalysts, price adjustments
2024	$4.20	Additional indications, increased market adoption
2025	$5.10	Competition intensifies; strategic marketing essential
2026	$6.00	Entry of biosimilars affecting biologics, but maintained market due to oral preference
2027	$6.50	Mature market penetration, new approvals for other autoimmune diseases

Key Drivers of Growth:

• Indication Expansion: Especially for UC and Crohn's disease
• Geographic Expansion: Entry into Asian and Latin American markets
• Advances in Clinical Data: Demonstrating safety and efficacy over competitors

Revenue Breakdown by Region & Indication (2022)

Region	Revenue (USD Million)	Percentage of Total Revenue	Key Indications
US	$1,800	65%	RA, PsA, UC
Europe	$600	22%	RA, PsA, UC
Rest of World	$350	13%	RA, PsA

Indication	Revenue (USD Million)	Share of total sales
RA	$2,250	82%
PsA	$350	13%
UC	$150	5%

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Competitive Landscape and Market Share

Major Competitors

Product	Type	Mechanism	Founded / Approved	Market Share (2022)	Key Differentiators
XELJANZ (upadacitinib)	JAK inhibitor	JAK1 selective	2019 / 2021 (FDA)	~25% (RA segment)	Oral, convenient, additional indications
Olumiant (baricitinib)	JAK inhibitor	JAK1/JAK2	2018 / 2019	~15%	Similar JAK profile, competitive pricing
Rinvoq (upadacitinib generic)	JAK inhibitor	JAK1	2019 / 2021	~10%	Similar mechanism, differentiated further by clinical data
Humira (adalimumab)	Monoclonal antibody	TNF-alpha	2003 / 2002 (US/EU)	30-40%	Biologic, high efficacy, biosimilar competition imminent

Market Penetration Strategies

Strategy	Description	Impact
Indication Expansion	FDA and EMA approvals in new autoimmune diseases	Diversify revenue streams
Geographical Expansion	Penetration into emerging markets	Support volume growth
Combination Therapy Approvals	Use with methotrexate, biologics	Improve efficacy profiles
Pricing & Reimbursement Negotiation	Cost-effectiveness assessments	Ensure market access

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Regulatory and Policy Environment

Region	Key Policies & Dates	Impacts
US (FDA)	Approved in August 2019 for RA; subsequent approvals for PsA (2020), UC (2022)	Accelerated approval pathways and label expansions enhance market potential
Europe (EMA/CND)	Approved in late 2019; expanded indications in 2022	Facilitates broader adoption
China (NMPA)	Approved in 2021	Opens substantial market, with government policies favoring innovative drugs
Reimbursement Trends	Prioritization of value-based pricing	Pressures margins, encourages outcomes-based contracts

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Future Outlook and Potential Disruptors

Factor	Implications	Details
Pipeline Innovations	Sustained growth	Clinical trials for Crohn’s, ulcerative colitis, and atopic dermatitis expected to deliver new approvals by 2025
Biosimilar Competition	Threat to biologic share	Biosimilar versions of biologics like Humira could erode market share beyond 2024
Emerging Therapies	Disruptive innovation	Cell-based immunotherapies and personalized medicine could alter conventional treatment paradigms
Policy & Pricing	New pricing policies	Governments’ emphasis on drug affordability may impact profit margins

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Comparative Analysis: XELJANZ Versus Key Competitors

Parameter	XELJANZ (upadacitinib)	Olumiant	Rinvoq	Humira
Mechanism	Selective JAK1 inhibitor	JAK1/JAK2 inhibitor	JAK1 selective	TNF-alpha monoclonal antibody
Oral/Injectable	Oral	Oral	Oral	Injectable (subcutaneous)
FDA Approval	2019+	2018+	2019+	2002 (biosimilars from 2023)
Estimated 2023 Sales	$3.45 bn	$1.4 bn	$1.25 bn	$20+ bn (pre-biosimilar)
Pricing	Premium	Slightly lower	Comparable	Premium, but biosimilar entry imminent

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FAQs

1. How does XELJANZ's mechanism differ from biologic treatments?

XELJANZ selectively inhibits JAK1, modulating cytokine signaling pathways involved in autoimmune inflammation. Unlike biologics that target specific cytokines or cells, XELJANZ offers oral administration and broad immunomodulation, providing convenience and potentially broader efficacy in certain patient populations.

2. What factors influence XELJANZ's market share in RA treatment?

Market share is driven by clinical efficacy, safety profile, regulatory approvals for new indications, patient preference for oral therapy, payer coverage, and competitive dynamics, notably the presence of biosimilar biologics.

3. What are the primary risks to XELJANZ’s future growth?

Safety concerns (thrombosis, infections), increasing biosimilar competition, pricing pressure, and regulatory restrictions pose potential risks. Additionally, emerging therapies like personalized biologics could shift treatment paradigms.

4. In which emerging markets is XELJANZ gaining momentum?

XELJANZ is expanding into China, India, and Latin America, facilitated by regulatory approvals and local manufacturing. Market access strategies target the large population of autoimmune disease patients.

5. How might future regulatory developments impact XELJANZ?

Stricter safety monitoring, new labeling requirements, or price regulation could impact sales. Conversely, positive outcomes from ongoing trials could facilitate approvals in additional indications, boosting revenue.

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Key Takeaways

• Market Expansion: XELJANZ's growth hinges on its expanding indication portfolio, especially in psoriasis, UC, and potentially Crohn’s disease.
• Competitive Position: Its oral JAK inhibitor profile provides a significant advantage over biologics but faces increasing biosimilar threats.
• Revenue Trajectory: Estimates project sales reaching ~$6.5 billion globally by 2027, driven by geographic expansion and pipeline progress.
• Strategic Challenges: Evolving safety profiles, reimbursement policies, and biosimilar competition necessitate active management.
• Future Outlook: Pipeline developments and emerging markets present significant opportunities, but regulatory and competitive pressures require strategic agility.

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References

[1] EvaluatePharma. "Pharmaceutical Market Forecasts." 2023.
[2] U.S. FDA. "XELJANZ (upadacitinib) Approval Details." August 2019.
[3] European Medicines Agency. "XELJANZ Regulatory Actions." 2022.
[4] CDC. "Prevalence of Rheumatoid Arthritis." 2022.
[5] Pharmaprojects. "Pipeline Updates & New Indications." 2023.

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This report aims to empower professional stakeholders with an in-depth understanding of XELJANZ’s current market status, competitive positioning, and growth prospects, facilitating informed decision-making.