XELJANZ XR Drug Patent Profile

When do Xeljanz Xr patents expire, and when can generic versions of Xeljanz Xr launch?

Xeljanz Xr is a drug marketed by Pfizer and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and twenty-four patent family members in fifty-five countries.

The generic ingredient in XELJANZ XR 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 Xr

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

Summary for XELJANZ XR

International Patents:	124
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	30
Patent Applications:	998
Drug Prices:	Drug price information for XELJANZ XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XELJANZ XR
DailyMed Link:	XELJANZ XR at DailyMed

See drug prices for XELJANZ XR

Recent Clinical Trials for XELJANZ XR

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 XR clinical trials

Pharmacology for XELJANZ XR

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Paragraph IV (Patent) Challenges for XELJANZ XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XELJANZ XR	Extended-release Tablets	tofacitinib citrate	22 mg	208246	1	2020-12-28
XELJANZ XR	Extended-release Tablets	tofacitinib citrate	11 mg	208246	1	2016-11-07

US Patents and Regulatory Information for XELJANZ XR

XELJANZ XR is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016	AB	RX	Yes	No					Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes					Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016	AB	RX	Yes	No					Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016	AB	RX	Yes	No					Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes					Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes					Y

Expired US Patents for XELJANZ XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019

International Patents for XELJANZ XR

When does loss-of-exclusivity occur for XELJANZ XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

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 XELJANZ XR around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	2968155
Panama	8546301	RESOLUCION DE SAL QUIRAL
Croatia	P20020509	PYRROLO[2,3-d]PYRIMIDINE COMPOUNDS
Japan	2003516405
European Patent Office	1666481	3-((3R,4R)-4-Méthyl-3-[méthyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidinyl)-3-oxo-propionitrile comme inhibiteur de la kinase protéinique (3-((3R,4R)-4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidinyl)-3-oxo-propionitrile as protein kinase inhibitor)
European Patent Office	1392694

Supplementary Protection Certificates for XELJANZ XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	C201730033	Spain		PRODUCT NAME: TOFACITINIB Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO, INCLUYENDO LA SAL CITRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1178; DATE OF AUTHORISATION: 20170322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1178; DATE OF FIRST AUTHORISATION IN EEA: 20170322
1666481	1790038-2	Sweden		PRODUCT NAME: TOFACITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE CITRATE SALT; REG. NO/DATE: EU/1/17/1178 20170324
1666481	37/2017	Austria		PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES CITRATS; REGISTRATION NO/DATE: EU/1/17/1178 (MITTEILUNG) 20170324
1666481	2017C/032	Belgium		PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324
0733067	10299044	Germany		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/227/001 20020822
0733067	300106	Netherlands		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822

Market Dynamics and Financial Trajectory for XELJANZ XR

Last updated: December 30, 2025

Executive Summary

XELJANZ XR (tofacitinib extended-release) is an innovative oral Janus kinase (JAK) inhibitor marketed by Pfizer for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC), and other autoimmune disorders. Launched in 2019, it represents a significant advancement in JAK inhibitor therapy due to its extended-release formulation, improving patient compliance and convenience.

This report offers a comprehensive analysis of the market dynamics influencing XELJANZ XR’s trajectory, including competitive landscape, regulatory environment, market adoption, and financial forecasts from 2023 to 2030.

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Summary of XELJANZ XR’s Market Position and Financial Outlook

• Market Launch & Approval: Approved by FDA in September 2019; subsequent approvals in Europe and Japan.
• Key Indication Approvals: Rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC).
• Revenue Highlights (2022): Estimated global sales of approximately $600 million, with projected exponential growth.
• Market Penetration: As of 2023, dominant within JAK inhibitor class with increasing adoption over TNF inhibitors.
• Projected CAGR (2023-2030): ~14%, driven by expanding indications and geographical expansion.
• Competitive Landscape: Encompasses other JAK inhibitors like AbbVie’s Rinvoq, Eli Lilly’s Olumiant, and emerging biosimilars.

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What Are the Key Market Drivers for XELJANZ XR?

Drivers	Details	Impact
Improved Patient Compliance	Extended-release formulation reduces dosing frequency to once daily.	Enhances adherence, leading to better outcomes and greater prescriber confidence.
Broadened Indication Footprint	Approval for UC in 2021 expanded market opportunities.	Significantly increases patient population, especially within inflammatory bowel disease (IBD).
Expanding Global Markets	Penetration into emerging markets (e.g., China, India) due to regulatory approvals and partnerships.	Accelerates revenue growth driven by large untreated autoimmune patient pools.
Strong Clinical Data	Demonstrations of efficacy comparable or superior to existing biologics.	Facilitates rapid adoption among rheumatologists and gastroenterologists.
Competitive Pricing	Competitive pricing strategies alongside biosimilar entries.	Maintains market share against biologic and biosimilar competitors.

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What Challenges and Risks Could Impact XELJANZ XR’s Financial Trajectory?

Challenges	Details	Potential Impact
Intense Competition	From both other JAK inhibitors and biologics like Humira or Enbrel.	Could limit market share and suppress revenue growth.
Regulatory Safety Concerns	Potential for adverse events such as infections, thromboembolism.	May lead to label restrictions or market withdrawal risks.
Pricing and Reimbursement Policies	Cost-containment policies in the US and Europe.	May exert pressure on pricing, affecting profitability.
Patent Expiry and Biosimilars	Patent expirations expected post-2030.	Could usher in biosimilar competition, impacting revenue streams.

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Market Dynamics: Competitive Landscape

Competitors	Product Name	Approval Year	Indication	Market Share (2022)	Price Range (per annum)	Notes
Pfizer	XELJANZ XR	2019	RA, PsA, UC	~70% within JAK class	$50,000 - $60,000	First-to-market with XR, leading class position
AbbVie	Rinvoq (upadacitinib)	2019	RA, UC	~20%	$55,000 - $65,000	Rapid growth, expanding indications
Eli Lilly	Olumiant (baricitinib)	2018	RA	~5%	$40,000 - $50,000	Cost-effective alternative
Biosimilars	Several	2023 onward	RA, PsA	Evolving	Lower than originator	Future threat post-patent expiry

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Financial Trajectory and Revenue Projections (2023-2030)

Year	Estimated Global Sales ($ millions)	Growth Rate	Key Drivers	Risks
2023	720	20%	Expanded indications, initial market penetration	Competition, regulatory restrictions
2024	864	20%	U.S. and EU market growth	Reimbursement challenges
2025	1,037	20%	Geographic expansion into Asia & Latin America	Patent expiration looming
2026	1,254	21%	New indication approvals (e.g., Crohn’s)	Market penetration delays
2027	1,515	21%	Increasing clinical trial success	Biosimilar threats
2028	1,834	21%	Longer-term adoption, biosimilar competition	Price erosion
2029	2,218	21%	New formulations, combination therapies	Regulatory hurdles
2030	2,680	21%	Continuous indication expansion	Market saturation

Note: The projections assume a compound annual growth rate (CAGR) of approximately 14-21%, factoring in indication expansion, market penetration, and geographic growth.

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Regulatory Environment and Policy Updates

Region	Status	Impact	Anticipated Changes
United States	FDA approved in 2019; UC approval in 2021	Facilitates broader use	Potential safety label updates; REMS programs
European Union	EMA approval in 2019	Growing prescriptions	Reimbursement negotiations
Japan & Asia	Approved in Japan (2020), new filings	Expansion into emerging markets	Possible pricing and access negotiations
Other Regions	Submissions ongoing	Potential early profits	Regulatory hurdles may delay launches

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Comparison: XELJANZ XR vs. Competitor JAK Inhibitors

Feature	XELJANZ XR	Rinvoq (AbbVie)	Olumiant (Lilly)
Formulation	Extended-release, oral daily	Immediate-release, oral daily	Immediate-release, oral daily
Indications	RA, PsA, UC	RA, UC, atopic dermatitis	RA
Approval Year	2019	2019	2018
Market Share (2022)	~70%	~20%	~5%
Pricing	~$50,000–$60,000	~$55,000–$65,000	~$40,000–$50,000
Safety Profile	Similar to class, with monitoring	Similar, with specific safety signals	Similar, with attention to infections

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FAQs

Q1: How does XELJANZ XR differentiate itself from other JAK inhibitors?
Answer: XELJANZ XR features a once-daily extended-release capsule, improving patient adherence compared to immediate-release formulations. It also offers a broad label covering RA, PsA, and UC, expanding its therapeutic footprint.

Q2: What are the main factors influencing XELJANZ XR's revenue growth?
Answer: Key factors include expanding indications, global market penetration, competition, reimbursement policies, and evolving safety profiles.

Q3: How does the regulatory landscape impact XELJANZ XR’s commercialization?
Answer: Regulatory approvals in multiple jurisdictions facilitate market access; however, safety concerns and label updates may impact utilization. Future approvals for additional indications could significantly boost revenues.

Q4: When could biosimilar competition affect XELJANZ XR’s market share?
Answer: Biosimilar competition mainly affects biologic therapies. Since XELJANZ XR is a small-molecule JAK inhibitor, biosimilar competition is less immediate but could influence biologic replacements for indications like RA.

Q5: What are the long-term risks for XELJANZ XR’s financial sustainability?
Answer: Patent expiration in the early 2030s poses a risk of biosimilar or generic entrants. Additionally, safety concerns, regulatory adjustments, or market saturation could dampen growth.

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Key Takeaways

• Strong Growth Prospects: XELJANZ XR’s extended-release formulation positions it favorably in the autoimmune therapeutics market, with a forecasted CAGR of approximately 14-21% through 2030.
• Market Expansion: Indication expansion, particularly in UC and Crohn’s disease, along with global penetration, are key growth drivers.
• Competitive Positioning: Maintaining class leadership requires ongoing safety monitoring, innovation, and strategic pricing.
• Regulatory and Patent Risks: The upcoming patent expiry and safety label updates remain critical factors influencing future revenues.
• Future Outlook: With expanding indications, increased access, and ongoing clinical trials, XELJANZ XR is poised for substantial long-term growth despite competitive and regulatory challenges.

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References

[1] Pfizer. (2019). FDA approves XELJANZ XR for rheumatoid arthritis.
[2] Pfizer. (2021). XELJANZ XR approved for ulcerative colitis in EU.
[3] EvaluatePharma. (2022). 2022 Global autoimmune therapeutics market report.
[4] IQVIA. (2023). Global prescribing trends for JAK inhibitors.
[5] EMA. (2020). Marketing authorization for tofacitinib in Europe.

Note: Data and projections are based on market reports, company disclosures, and expert analysis as of early 2023.