XELJANZ XR Drug Patent Profile

When do Xeljanz Xr patents expire, and what generic alternatives are available?

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-three 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. Four 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 DEXCEL on December 16^th, 2024.

Summary for XELJANZ XR

International Patents:	123
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	30
Patent Applications:	106
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	RE41783*PED				Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016	AB	RX	Yes	No	9,937,181*PED				Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016	AB	RX	Yes	No	11,253,523*PED				Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes	RE41783*PED				Y
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes	11,253,523*PED				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	7,265,221
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019	6,965,027
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016	7,842,699
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016	6,965,027
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019	7,301,023

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
Brazil	PI0016263	compostos pirrolo[2,3-d]pirimidina, composição farmacêutica que os compreende e uso dos referidos compostos
Colombia	5271665	(COMPUESTOS DE PIRROLO [2,3-D] PIRIMIDINA
Czech Republic	20021846
Germany	60007552
Morocco	26851

Supplementary Protection Certificates for XELJANZ XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0733067	02C0048	France		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822
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
0733067	300106	Netherlands		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/228/001 20020822
0733067	6/2003	Austria		PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/227/001 20020822
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 XR

Introduction

XELJANZ XR, the extended-release formulation of tofacitinib, is a Janus kinase (JAK) inhibitor developed by Pfizer. It has been approved for various indications, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ulcerative colitis (UC). This article delves into the market dynamics and financial trajectory of XELJANZ XR, considering factors such as patent expiry, generic competition, pricing strategies, and market growth.

Approval and Indications

XELJANZ XR was approved by the U.S. Food and Drug Administration (FDA) for RA and PsA, and it is the only JAK inhibitor authorized in the United States for five immuno-inflammatory diseases, including axial spondyloarthritis (AxSpA)[1][4].

Patent Expiry and Generic Competition

One of the critical factors influencing the market dynamics of XELJANZ XR is the impending patent expiry. The strongest patent for Xeljanz is set to expire in December 2025, although a potential pediatric extension could add six months of patent protection. However, the twice-daily formulation of Xeljanz is expected to face generic competition in the United States and Japan by 2026 and in Europe by 2027. The once-daily XELJANZ XR formulation is anticipated to remain under patent beyond the 10-year forecast period[1].

Market Impact of Generic Entry

The entry of generic competitors will significantly impact the market dynamics of XELJANZ XR. Pfizer is likely to implement an aggressive switch campaign to transition patients from the twice-daily formulation to the once-daily XR version, which offers competitive once-daily dosing and extended patent protection. This strategy is analogous to Pfizer's approach with Effexor/Effexor XR, where the XR version was promoted after the original formulation faced patent loss[1].

Regional Variability

The timing of generic entry will vary by region due to different patent and exclusivity periods. The United States and Japan are expected to be the first major markets with generic Xeljanz, followed by the EU5 as early as 2027. This regional variability can be modeled using examples like Eli Lilly’s Cymbalta, which saw generics enter the U.S. market in 2013 and the European market in 2015[1].

Pricing Strategies

In an increasingly cost-conscious healthcare environment, pricing is a crucial factor. The current price of branded Xeljanz is competitive with other targeted therapies in the RA, PsA, and UC markets. Generic manufacturers are unlikely to launch their products at significantly lower prices but will still offer substantial discounts relative to the brand. This pricing dynamic is similar to the migraine market, where generic triptans have different discounts based on factors like method of administration and the number of generic competitors[1].

Financial Performance

Pfizer's financial reports highlight the significant contribution of Xeljanz to the company's revenue. In 2019, Xeljanz was one of the key drivers of Pfizer's Biopharma business, which saw an 8% operational revenue growth. The drug's performance has been robust, contributing to Pfizer's overall revenue growth[5].

Market Growth and Projections

The tofacitinib market, which includes XELJANZ XR, is expected to grow rapidly. From $2.76 billion in 2023, the market is projected to grow to $3.12 billion in 2024 and further to $5.02 billion by 2028, driven by expanded indications, market access initiatives, and real-world evidence[4].

Competitive Landscape

XELJANZ XR operates in a competitive landscape with other JAK inhibitors and biosimilars. For instance, Olumiant (baricitinib), another JAK inhibitor, has been gaining traction with its lower price point and potential approvals for additional indications. However, XELJANZ XR's once-daily dosing and extended patent protection give it a competitive edge[3].

Product Innovation

Pfizer continues to innovate within the tofacitinib market. The FDA approval of supplemental New Drug Applications (sNDAs) for XELJANZ and XELJANZ XR in December 2021 underscores the company's commitment to expanding the drug's indications and improving patient outcomes[4].

Real-World Evidence and Personalized Medicine

The integration of real-world evidence into treatment guidelines and the focus on personalized medicine approaches are key trends in the tofacitinib market. These strategies help in sustaining the market position of XELJANZ XR by providing robust clinical data and tailored treatment options[4].

Strategic Collaborations

Strategic collaborations and partnerships are crucial for maintaining market dominance. Pfizer's collaborations and partnerships help in expanding market access, conducting clinical trials, and developing innovative products, all of which contribute to the financial trajectory of XELJANZ XR[4].

Conclusion

The market dynamics and financial trajectory of XELJANZ XR are influenced by several factors, including patent expiry, generic competition, pricing strategies, and market growth. As the drug faces generic competition, Pfizer's strategic switch to the once-daily XR formulation and aggressive marketing campaigns will be pivotal. The drug's robust financial performance and projected market growth indicate a strong future, despite the competitive landscape.

Key Takeaways

• Patent Expiry: Generic competition expected in the U.S. and Japan by 2026 and in Europe by 2027.
• Pricing Strategies: Generic versions will be deeply discounted but not drastically lower than the brand.
• Market Growth: Projected growth from $2.76 billion in 2023 to $5.02 billion by 2028.
• Competitive Edge: Once-daily dosing and extended patent protection for XELJANZ XR.
• Innovation: Continued product innovation and expansion of indications.
• Real-World Evidence: Integration into treatment guidelines to sustain market position.

FAQs

Q: When is the patent for Xeljanz expected to expire? A: The strongest patent for Xeljanz is set to expire in December 2025, with a potential six-month extension if a pediatric extension is granted[1].

Q: How will Pfizer respond to generic competition? A: Pfizer is likely to implement an aggressive switch campaign to transition patients from the twice-daily formulation to the once-daily XR version[1].

Q: What is the projected market size for tofacitinib by 2028? A: The tofacitinib market is expected to grow to $5.02 billion by 2028 at a CAGR of 12.7%[4].

Q: How does XELJANZ XR compare to other JAK inhibitors in terms of pricing? A: XELJANZ XR is competitively priced, similar to or lower than other targeted therapies in the RA, PsA, and UC markets. Generic versions will be discounted but not drastically lower than the brand[1].

Q: What are the key trends in the tofacitinib market? A: Key trends include focus on pediatric rheumatoid arthritis treatment, exploration in dermatological conditions, strategic collaborations, integration of real-world evidence, and personalized medicine approaches[4].