XELJANZ Drug Patent Profile

Which patents cover Xeljanz, and when can generic versions of Xeljanz launch?

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^® Generic Entry Outlook for Xeljanz

Xeljanz was eligible for patent challenges on November 6, 2016.

There have been twenty-five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (tofacitinib citrate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XELJANZ

International Patents:	75
US Patents:	1
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	30
Patent Applications:	106
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 one FDA Regulatory Exclusivity.

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			Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes	10,639,309		Y
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018		RX	Yes	Yes	RE41783			Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No	RE41783			Y
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No	11,253,523

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	203214-002	May 30, 2018	6,965,027
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012	6,965,027
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012	7,842,699
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020	6,956,041
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018	7,301,023
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018	7,265,221
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018	7,842,699

International Patents for XELJANZ

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

Country	Patent Number	Title	Estimated Expiration
Peru	10962001
Argentina	037321	COMPUESTOS DE PIRROLO(2,3-D) PIRIMIDINA, INHIBIDORES DE PROTEINA QUINASAS UTILES COMO AGENTES INMUNOSUPRESORES
Colombia	5271665	(COMPUESTOS DE PIRROLO [2,3-D] PIRIMIDINA
Peru	20030561	RESOLUCION DE SAL QUIRAL
Poland	221493
World Intellectual Property Organization (WIPO)	03048162
Hong Kong	1070653

Supplementary Protection Certificates for XELJANZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	132017000095300	Italy		PRODUCT NAME: TOFACITINIB, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE, COMPRENDENTE IL SALE CITRATO(XELJANZ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1178/001-004, 20170324
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	PA2017025	Lithuania		PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481	2017/036	Ireland		PRODUCT NAME: TOFACITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE CITRATE SALT; REGISTRATION NO/DATE: EU/1/17/1178/001 EU/1/17/1178/004 20170322
1666481	122017000062	Germany		PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1235830	C01235830/01	Switzerland		PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013
1666481	2017C/032	Belgium		PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324

XELJANZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XELJANZ

Introduction

XELJANZ, also known as tofacitinib, is a Janus kinase (JAK) inhibitor developed by Pfizer Inc. It is used to treat various immuno-inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis. Here, we delve into the market dynamics and financial trajectory of XELJANZ.

Mechanism of Action and Indications

XELJANZ works by inhibiting the Janus kinase enzymes, which are involved in the signaling pathways of various cytokines that drive inflammation. This mechanism makes it effective in treating several autoimmune diseases. It is the first and only JAK inhibitor authorized in the United States for treating five immuno-inflammatory diseases[3][4].

Market Size and Growth

The global tofacitinib market, led by XELJANZ, has seen significant fluctuations in recent years. As of 2023, the global sales of XELJANZ stood at USD 1,703 million, marking a historical decline of 11% from 2020 to 2023. However, the overall tofacitinib market is expected to grow from $2.43 billion in 2022 to $2.76 billion in 2023, with a projected CAGR that will see the market reach $4.4 billion by 2027[3].

Regional Performance

North America has been the largest region for the tofacitinib market, driven by the high prevalence of rheumatoid arthritis and other autoimmune diseases. The Asia-Pacific region is expected to be the fastest-growing market in the forecast period, driven by increasing healthcare spending and a growing patient population[4].

Product Innovation and Regulatory Approvals

Pfizer has been actively innovating and expanding the indications for XELJANZ. In December 2021, the FDA approved a supplemental New Drug Application (sNDA) for XELJANZ and XELJANZ XR, further solidifying its position in the market. This approval was based on a Phase 3 study that demonstrated the safety and efficacy of tofacitinib in treating ankylosing spondylitis[3][4].

Competitive Landscape

The tofacitinib market is highly competitive, with major pharmaceutical companies focusing on product innovation to maintain their market share. Pfizer's acquisition of Arena Pharmaceuticals in March 2022 for $6.7 billion has broadened its portfolio, adding potential drugs for gastroenterology, dermatology, and cardiology, as well as a potential successor to XELJANZ[3][4].

Financial Performance of Pfizer

Pfizer's financial performance has been significantly impacted by the sales of XELJANZ, although the company's overall revenue has been dominated by COVID-19 products like Comirnaty and Paxlovid in recent years. In 2023, Pfizer reported full-year revenues of $58.5 billion, a decline of 42% compared to 2022, largely due to the decrease in sales of COVID-19 products. However, excluding these products, Pfizer's revenues grew 7% operationally, driven by new product launches and in-line product growth[2].

Revenue Breakdown

• 2023 Revenue: $1,703 million for XELJANZ, contributing to Pfizer's overall biopharmaceutical revenues.
• Operational Growth: Excluding COVID-19 products, Pfizer's revenues grew 7% operationally in 2023, indicating a positive trend for other products like XELJANZ[2].

Challenges and Decline

Despite its market position, XELJANZ has faced a decline in sales. The historical decline of 11% from 2020 to 2023 is attributed to various factors, including market competition and the impact of COVID-19 on healthcare spending. GlobalData projects a continued decline in the sales of XELJANZ, although the overall tofacitinib market is expected to grow[1].

Patient Prevalence and Market Demand

The increasing prevalence of rheumatoid arthritis and other autoimmune diseases drives the demand for XELJANZ. According to the National Arthritis Data Workgroup, over 52.5 million American adults had been diagnosed with arthritis or another type of rheumatic disease by February 2022, and this number is projected to reach 67 million by 2030[3].

Strategic Moves by Pfizer

Pfizer has been making strategic moves to enhance its portfolio and maintain market competitiveness. The acquisition of Arena Pharmaceuticals and the realignment of its commercial organization are steps aimed at improving focus, speed, and execution in the market[2].

Acquisition of Arena Pharmaceuticals

The acquisition of Arena Pharmaceuticals for $6.7 billion has added several potential drugs to Pfizer's pipeline, including those for gastroenterology, dermatology, and cardiology. This move is expected to provide a potential successor to XELJANZ and diversify Pfizer's portfolio[3][4].

Future Outlook

Despite the current decline, the tofacitinib market, led by XELJANZ, is expected to grow driven by product innovation and increasing patient demand. The Asia-Pacific region is anticipated to be a key growth driver, and Pfizer's strategic moves are aimed at capturing this growth potential.

Key Takeaways

• Market Size: The global tofacitinib market is projected to reach $4.4 billion by 2027.
• Regional Growth: Asia-Pacific is expected to be the fastest-growing region.
• Product Innovation: Continuous innovation and regulatory approvals are crucial for market competitiveness.
• Financial Performance: Pfizer's revenues excluding COVID-19 products show operational growth.
• Patient Prevalence: Increasing prevalence of autoimmune diseases drives market demand.

FAQs

Q: What is the mechanism of action of XELJANZ?

A: XELJANZ works by inhibiting the Janus kinase enzymes, which are involved in the signaling pathways of various cytokines that drive inflammation.

Q: What are the indications for XELJANZ?

A: XELJANZ is indicated for the treatment of adult patients with active ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

Q: How has the global tofacitinib market performed in recent years?

A: The global tofacitinib market has seen a decline in XELJANZ sales but is expected to grow from $2.43 billion in 2022 to $4.4 billion by 2027.

Q: What regions are driving the growth of the tofacitinib market?

A: North America is currently the largest region, but the Asia-Pacific region is expected to be the fastest-growing in the forecast period.

Q: What strategic moves has Pfizer made to enhance its market position?

A: Pfizer has acquired Arena Pharmaceuticals and realigned its commercial organization to improve focus, speed, and execution.

Sources

1. GlobalData, "The Global Drug sales of Xeljanz (2020 - 2026, USD Millions)"
2. Pfizer, "Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance"
3. PR Newswire, "Global Tofacitinib Market Report 2023: Market to Reach $4.4 Billion in 2027"
4. The Business Research Company, "Tofacitinib Market Report 2024"
5. Pfizer, "PFIZER REPORTS RECORD FULL-YEAR 2022 RESULTS AND PROVIDES FULL-YEAR 2023 GUIDANCE"