Tofacitinib citrate - Generic Drug Details

What are the generic sources for tofacitinib citrate and what is the scope of freedom to operate?

Tofacitinib citrate is the generic ingredient in four branded drugs marketed by Hikma, Pfizer, Aurobindo Pharma Ltd, Zydus Pharms, Dexcel, Ajanta Pharma Ltd, Micro Labs, and Pf Prism Cv, and is included in ten NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tofacitinib citrate has one hundred and twenty-three patent family members in fifty-five countries.

There are twelve drug master file entries for tofacitinib citrate. Two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for tofacitinib citrate

International Patents:	123
US Patents:	4
Tradenames:	4
Applicants:	8
NDAs:	10
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	10
Patent Applications:	222
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tofacitinib citrate
DailyMed Link:	tofacitinib citrate at DailyMed

Recent Clinical Trials for tofacitinib citrate

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

Sponsor	Phase
China-Japan Friendship Hospital	Phase 4
CAGE Bio Inc.	Phase 1/Phase 2
Services Institute of Medical Sciences, Pakistan	Early Phase 1

See all tofacitinib citrate clinical trials

Generic filers with tentative approvals for TOFACITINIB CITRATE

Applicant	Application No.	Strength	Dosage Form
		EQ 5MG BASE	TABLET;ORAL
		EQ 10MG BASE	TABLET;ORAL
		10MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for tofacitinib citrate

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for tofacitinib citrate

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AF	Janus-associated kinase (JAK) inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for TOFACITINIB CITRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XELJANZ	Oral Solution	tofacitinib citrate	1 mg/mL	213082	1	2021-11-12
XELJANZ XR	Extended-release Tablets	tofacitinib citrate	22 mg	208246	1	2020-12-28
XELJANZ	Tablets	tofacitinib citrate	10 mg	203214	1	2019-07-24
XELJANZ	Tablets	tofacitinib citrate	5 mg	203214	3	2016-11-07
XELJANZ XR	Extended-release Tablets	tofacitinib citrate	11 mg	208246	1	2016-11-07

US Patents and Regulatory Information for tofacitinib citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	TOFACITINIB	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	218462-001	Jun 3, 2024		DISCN	No	No
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016		RX	Yes	No					Y
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020		RX	Yes	Yes
Micro Labs	TOFACITINIB CITRATE	tofacitinib citrate	TABLET;ORAL	209738-001	Mar 13, 2023		DISCN	No	No
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020		RX	Yes	Yes

Expired US Patents for tofacitinib citrate

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
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020

International Patents for tofacitinib citrate

Country	Patent Number	Title	Estimated Expiration
Slovenia	2968155
Brazil	112015020453	formas de dosagem de liberação prolongada orais de tofacitinibe
Hong Kong	1051195
Bulgaria	65821
South Korea	102151842

Supplementary Protection Certificates for tofacitinib citrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	122017000062	Germany		PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 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	PA2017025	Lithuania		PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481	CR 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	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

Market Dynamics and Financial Trajectory for Tofacitinib Citrate

Introduction

Tofacitinib citrate, marketed under the brand name Xeljanz among others, is a Janus kinase (JAK) inhibitor used in the treatment of various autoimmune and inflammatory conditions. The drug has seen significant growth in recent years, driven by several key factors.

Market Size and Growth

The global tofacitinib market has experienced rapid expansion. In 2023, the market size was valued at $2.76 billion and is projected to grow to $3.12 billion in 2024, reflecting a compound annual growth rate (CAGR) of 13.0% to 13.4%[3][4][5].

By 2028, the market is expected to reach $5.02 billion at a CAGR of 12.7%, and by 2027, it is anticipated to reach $4.40 billion at a CAGR of 12.4%[3][4].

Drivers of Market Growth

Several factors are driving the growth of the tofacitinib market:

Expanded Indications

Tofacitinib has been approved for treating various conditions, including rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis. The expansion of indications has significantly broadened its market reach[3][4].

Rise in Prevalence of Targeted Conditions

The increasing prevalence of rheumatoid arthritis and inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis is a major driver. For instance, over 52.5 million American adults have been diagnosed with arthritis or other rheumatic diseases, and this number is projected to reach 67 million by 2030[1][3][4].

Market Access Initiatives

Efforts to improve market access, including strategic collaborations and partnerships, have facilitated the drug's penetration into various markets. These initiatives often involve cost-saving measures and better distribution channels[1][4].

Real-World Evidence and Patient-Centric Healthcare

The integration of real-world evidence into treatment guidelines and a focus on patient-centric healthcare have enhanced the drug's acceptance and usage. This approach ensures that treatments are more tailored to patient needs, leading to better outcomes and higher patient satisfaction[1][4].

Competitive Landscape

The tofacitinib market is highly competitive, with major pharmaceutical companies like Pfizer Inc. playing a significant role. Pfizer's Xeljanz and Xeljanz XR have received FDA approvals for various indications, contributing to the market's growth[3].

Product Innovation

Companies are investing heavily in product innovation to maintain their competitive edge. For example, Pfizer's supplemental New Drug Application (sNDA) for tofacitinib-based medications has expanded the drug's therapeutic scope[3].

Regional Analysis

The tofacitinib market is segmented by region, with the Asia-Pacific region showing significant growth. Factors such as government initiatives, regulatory bodies, and major associations in this region are contributing to the market's expansion[1].

Distribution Channels

The market is also segmented by distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies. The ease of access through these channels has contributed to the drug's widespread adoption[4].

Economic Evaluation and Budget Impact

Studies have shown that tofacitinib can result in cost savings compared to other treatments. For instance, a cost-minimization analysis indicated that the incorporation of tofacitinib could result in cost savings ranging from BRL 1,336.74 to BRL 14,940.94 compared to other biological DMARDs[2].

Adverse Events and Safety Profile

While tofacitinib has shown significant efficacy, it also comes with a profile of adverse events. Common serious infections include pneumonia, cellulitis, herpes zoster, and urinary tract infections. However, these risks are managed through careful patient monitoring and adherence to treatment guidelines[5].

Future Trends

Focus on Pediatric Rheumatoid Arthritis

There is an increasing focus on treating pediatric rheumatoid arthritis with tofacitinib, which is expected to further expand the market[1][4].

Exploration in Dermatological Conditions

Research into the use of tofacitinib for dermatological conditions is ongoing, which could open up new market opportunities[1][4].

Strategic Collaborations and Partnerships

Continued strategic collaborations and partnerships among pharmaceutical companies are expected to drive innovation and market growth[1][4].

Integration of Real-World Evidence

The integration of real-world evidence into treatment guidelines will continue to play a crucial role in the adoption and efficacy of tofacitinib[1][4].

Personalized Medicine Approaches

A focus on personalized medicine approaches will tailor treatments more effectively to individual patient needs, enhancing the drug's market position[1][4].

Key Takeaways

• The tofacitinib market is expected to grow significantly, driven by expanded indications, rising prevalence of targeted conditions, and market access initiatives.
• The market will reach $5.02 billion by 2028 at a CAGR of 12.7%.
• Real-world evidence and patient-centric healthcare are key drivers of the market.
• Product innovation and strategic collaborations are crucial for maintaining competitiveness.
• The drug's safety profile, while manageable, includes serious infections that require careful monitoring.

Frequently Asked Questions

Q: What are the primary indications for tofacitinib citrate? A: Tofacitinib citrate is primarily used to treat conditions such as rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.

Q: What is the projected market size of tofacitinib by 2028? A: The tofacitinib market is expected to reach $5.02 billion by 2028.

Q: How does tofacitinib compare to other treatments in terms of cost? A: Studies have shown that tofacitinib can result in cost savings compared to other biological DMARDs, ranging from BRL 1,336.74 to BRL 14,940.94.

Q: What are the common adverse events associated with tofacitinib? A: Common adverse events include serious infections such as pneumonia, cellulitis, herpes zoster, and urinary tract infections.

Q: What are some future trends expected in the tofacitinib market? A: Future trends include a focus on pediatric rheumatoid arthritis, exploration in dermatological conditions, strategic collaborations, integration of real-world evidence, and personalized medicine approaches.

Cited Sources

1. ResearchAndMarkets.com: "Tofacitinib Global Market Size, Competitors & Forecast"
2. Conitec: "Tofacitinib citrate for the treatment of moderate to severe active psoriatic arthritis"
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. VA Pharmacy Benefits Management: "Tofacitinib (Xeljanz®) - VA Pharmacy Benefits Management"

Last updated: 2024-12-17