Tipiracil hydrochloride; trifluridine - Generic Drug Details

What are the generic drug sources for tipiracil hydrochloride; trifluridine and what is the scope of freedom to operate?

Tipiracil hydrochloride; trifluridine is the generic ingredient in two branded drugs marketed by Taiho Oncology, MSN, and Natco, and is included in three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tipiracil hydrochloride; trifluridine has one hundred and twenty-two patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for tipiracil hydrochloride; trifluridine

International Patents:	122
US Patents:	6
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	89
Patent Applications:	1,797
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tipiracil hydrochloride; trifluridine
DailyMed Link:	tipiracil hydrochloride; trifluridine at DailyMed

Recent Clinical Trials for tipiracil hydrochloride; trifluridine

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

Sponsor	Phase
National Cancer Institute (NCI)	PHASE2
Strategic Alliance	PHASE2
M.D. Anderson Cancer Center	PHASE2

See all tipiracil hydrochloride; trifluridine clinical trials

Pharmacology for tipiracil hydrochloride; trifluridine

Drug Class	Nucleoside Analog Antiviral Nucleoside Metabolic Inhibitor Thymidine Phosphorylase Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors Thymidine Phosphorylase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for tipiracil hydrochloride; trifluridine

S01AD	Antivirals
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LONSURF	Tablets	tipiracil hydrochloride; trifluridine	15 mg/6.14 mg and 20 mg/8.19 mg	207981	4	2019-09-23

US Patents and Regulatory Information for tipiracil hydrochloride; trifluridine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes
Msn	TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	tipiracil hydrochloride; trifluridine	TABLET;ORAL	214024-002	Jan 8, 2025	AB	RX	No	No
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No

Expired US Patents for tipiracil hydrochloride; trifluridine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015

International Patents for tipiracil hydrochloride; trifluridine

Country	Patent Number	Title	Estimated Expiration
South Korea	20160020560
Japan	6526883
Malaysia	173410	STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME

Supplementary Protection Certificates for tipiracil hydrochloride; trifluridine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1849470	132017000102371	Italy		PRODUCT NAME: TRIFLURDINA IN COMBINAZIONE CON TIPIRACILE O UN SALE DI TIPIRACILE QUALE TIPIRACILE IDROCLORURO(LONSURF); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1096, 20160427
1849470	C 2017 032	Romania		PRODUCT NAME: TRIFLURIDINA IN COMBINATIE CU TIPIRACIL SAU O SARE ACCEPTABILA FARMACEUTIC DE TIPIRACIL CUM AR FI CLORHIDRAT DE TIPIRACIL; NATIONAL AUTHORISATION NUMBER: EU/1/16/1096; DATE OF NATIONAL AUTHORISATION: 20160425; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1096; DATE OF FIRST AUTHORISATION IN EEA: 20160425
1849470	PA2017024,C1849470	Lithuania		PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425

Market Dynamics and Financial Trajectory for TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Last updated: July 28, 2025

Introduction

The combination of Tipiracil Hydrochloride and Trifluridine (marketed as Lonsurf®) has carved a distinct niche in the oncology therapeutics landscape. Designed primarily for the treatment of metastatic colorectal cancer (mCRC) and gastric cancers, this nucleoside-based therapy exemplifies targeted cancer treatment advancements. Given the evolving oncology market, understanding the drug’s market dynamics and financial trajectory is essential for stakeholders, from pharma companies to investors and healthcare providers.

Market Overview

Tipiracil Hydrochloride; Trifluridine's market presence is primarily anchored in the global oncology drug sector. The rising prevalence of colorectal and gastric cancers, driven by demographic shifts, lifestyle factors, and aging populations, fuels demand. According to the World Health Organization (WHO), colorectal cancer accounts for approximately 10% of all cancers worldwide, ranking third in incidence, with a substantial burden in North America, Europe, and Asia-Pacific regions. Gastric cancers' global incidence is also significant, especially in East Asia. The expanding patient base, coupled with limited treatment options for refractory cases, bolsters the importance of drugs like Lonsurf®.

Market Drivers

1. Growing Incidence of Target Cancers
   The steady rise in colorectal and gastric cancer cases propels demand for effective chemotherapeutic agents. Notably, the rising adoption of second- and third-line therapies elevates the relevance of Tipiracil Hydrochloride; Trifluridine, which caters to refractory cases post standard treatments.

2. FDA and Global Approvals
   Lonsurf® secured FDA approval in 2015 for mCRC and later expanded to gastric cancers, cementing its market presence. Similar approvals in Europe, Japan, and other regions facilitate a broader geographic footprint.

3. R&D and Innovation
   Continual research aims to optimize dosing, combination strategies, and identify new indications. Ongoing clinical trials exploring neoadjuvant settings, adjuvant therapies, and combination with immunotherapies could expand the drug’s application.

4. Patient-centric Healthcare Shifts
   The movement toward personalized, targeted treatments favors nucleoside analogues like Trifluridine. Enhanced efficacy, coupled with manageable toxicity profiles, encourages physician adoption.

Market Challenges

1. Competitive Landscape
   The anti-angiogenic agents, immune checkpoint inhibitors, and other chemotherapies challenge Tipiracil Hydrochloride; Trifluridine's market dominance. The emergence of biosimilars and novel agents may suppress pricing and reimbursement.

2. Pricing and Reimbursement Constraints
   High costs associated with cancer drugs strain healthcare budgets, especially in emerging markets, limiting access and impacting sales.

3. Limited Indication Spectrum
   Currently approved explicitly for refractory colorectal and gastric cancers, limiting revenue streams unless new indications are identified.

4. Clinical and Regulatory Hurdles
   Need for ongoing robust clinical data to support expanded indications and reimbursement policies.

Financial Trajectory

Historical Sales Performance

Since its launch, Lonsurf® has exhibited consistent revenue growth. In 2021, global sales surpassed $1.2 billion, reflecting rapid adoption in key markets such as the US, Japan, and Europe. The drug's sales momentum is sustained by the growing prevalence of target cancers and clinician familiarity.

Forecasted Growth and Market Penetration

According to market research firms like IQVIA and Evaluate Pharma, sales are projected to grow at a compound annual growth rate (CAGR) of approximately 8-10% through 2028. Key factors include:

• Expansion into additional indications, such as earlier lines of therapy or adjuvant settings.
• Launch in emerging markets, notably China and Latin America, where cancer burden is increasing, and access barriers are decreasing.
• Combination regimens with immunotherapies, potentially boosting efficacy and sales.

Pricing Strategies and Margins

Lonsurf® commands premium pricing, justified by its targeted mechanism and clinical benefits. Negotiations with payers and price adjustments in different markets influence profit margins. As production scales up, economies of scale are expected to improve margins further.

Regulatory and Commercial Risks

The trajectory is sensitive to clinical trial outcomes, regulatory shifts, and competitive innovations. Disruptions could temper sales growth or necessitate strategic pivots.

Future Opportunities

• New Indications: Potential approval for earlier treatment lines could exponentially increase sales.
• Combination Therapies: Synergies with immunotherapies or targeted agents can enhance therapeutic outcomes and market share.
• Biotechnology Collaborations: Partnerships for biosimilar development or innovative delivery platforms.

Conclusion

Tipiracil Hydrochloride; Trifluridine’s market trajectory hinges on its ability to navigate competitive pressures, expand indications, and deliver superior clinical value. Its strong current performance, coupled with ongoing R&D and strategic expansion, suggests a promising future within the targeted oncology segment.

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Key Takeaways

• The rising global cancer burden, notably colorectal and gastric cancers, fuels demand for drugs like Lonsurf®.
• Expanding approvals and clinical trials for new indications are critical to sustained revenue growth.
• Competitive environment and pricing dynamics remain key challenges, requiring strategic pricing and manufacturing efficiencies.
• Opportunities for combination therapies and market expansion into emerging economies can significantly enhance financial prospects.
• Continuous innovation and regulatory engagement are essential to sustain market leadership and growth.

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FAQs

Q1: What are the main indications for Tipiracil Hydrochloride; Trifluridine?
A1: It is approved primarily for refractory metastatic colorectal cancer and gastric adenocarcinoma in various regions, often used as a third-line therapy.

Q2: How does the global incidence of colorectal and gastric cancers influence the drug’s market potential?
A2: The increasing prevalence amplifies demand, especially in regions with high incidence rates, providing substantial growth opportunities.

Q3: What are the key factors affecting the pricing and reimbursement of Lonsurf® globally?
A3: Market exclusivity, clinical efficacy, negotiation with payers, healthcare policies, and regional pricing regulations significantly impact pricing and reimbursement.

Q4: Are there ongoing trials to expand the usage of Tipiracil Hydrochloride; Trifluridine?
A4: Yes; clinical trials exploring its role in earlier lines of therapy, adjuvant settings, and combination with immunotherapies are underway.

Q5: How do competitive therapies impact the financial outlook for this drug?
A5: Competition from immunotherapies and other targeted agents could reduce market share and sales unless Lonsurf® adapts through indication expansion or combination strategies.

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Sources:

[1] World Health Organization (WHO). Cancer statistics overview.
[2] Evaluate Pharma. Oncology market reports 2022.
[3] FDA Approval Announcement for Lonsurf®.
[4] IQVIA. Global Oncology Market Trends.
[5] Company Financial Statements and Investor Reports.