lonsurf Drug Patent Profile

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

Lonsurf is a drug marketed by Taiho Oncology and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-two patent family members in thirty-four countries.

The generic ingredient in LONSURF is tipiracil hydrochloride; trifluridine. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tipiracil hydrochloride; trifluridine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lonsurf

A generic version of lonsurf was approved as tipiracil hydrochloride; trifluridine by NATCO on June 13^th, 2023.

Summary for lonsurf

International Patents:	122
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	60
Patent Applications:	749
Drug Prices:	Drug price information for lonsurf
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lonsurf
What excipients (inactive ingredients) are in lonsurf?	lonsurf excipients list
DailyMed Link:	lonsurf at DailyMed

See drug prices for lonsurf

Recent Clinical Trials for lonsurf

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

Sponsor	Phase
Novotech (Australia) Pty Limited	PHASE2
Kahr Bio Australia Pty Ltd	PHASE2
UNICANCER	PHASE2

See all lonsurf clinical trials

Pharmacology for lonsurf

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

Paragraph IV (Patent) Challenges for LONSURF

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 lonsurf

lonsurf is protected by ten 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
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes			Y	Y
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No

Expired US Patents for lonsurf

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
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015

International Patents for lonsurf

When does loss-of-exclusivity occur for lonsurf?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Georgia, Republic of

Hong Kong

Hungary

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Philippines

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

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 lonsurf around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2018219967	Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Portugal	763529
Australia	2014282281
Japan	WO2017135412
Spain	2946472

Supplementary Protection Certificates for lonsurf

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	LUC00036	Luxembourg		PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470	CA 2017 00036	Denmark		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
1849470	122017000052	Germany		PRODUCT NAME: TRIFLURIDIN IN KOMBINATION MIT TIPIRACIL ODER EINEM SALZ VON TIPIRACIL WIE TIPIRACIL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470	PA2017024	Lithuania		PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425

Market Dynamics and Financial Trajectory for Lonsurf

Last updated: December 30, 2025

Summary

Lonsurf (trifluridine/tipiracil) is an oral chemotherapeutic agent approved for metastatic colorectal cancer (mCRC) and metastatic gastric or gastroesophageal junction adenocarcinoma. Since its launch in 2015, Lonsurf has experienced variable growth influenced by regulatory decisions, clinical trial outcomes, market penetration, and competitive dynamics. Currently, the drug's revenue trajectory faces both opportunities and challenges stemming from pipeline developments, evolving treatment landscapes, and regional market access factors. This analysis delineates the market landscape, evaluates financial performance, explores future growth drivers, and compares Lonsurf against competitors to aid strategic decision-making.

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1. Introduction to Lonsurf: Composition, Indications, and Approval Timeline

Lonsurf Composition:

• Active ingredients: Trifluridine (antineoplastic) and Tipiracil (thyminesase inhibitor)
• Mechanism: Orally administered nucleoside analog combo that integrates into DNA, disrupting tumor cell replication.

Key Indications:

• metastatic colorectal adenocarcinoma (mCRC) in refractory settings
• Metastatic gastric or gastroesophageal junction adenocarcinoma (since 2019 in select regions)

Regulatory Milestones:	Year	Region	Approval	Notes
2015	US	FDA approval	First approval for mCRC after prior therapies
2017	EU	EMA approval	Broad access across European countries
2019	Japan	PMDA approval	Indicated for gastric cancer

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2. Current Market Dynamics

2.1. Market Penetration and Revenue Performance

Year	Global Sales (USD millions)	Growth Rate	Key Markets	Comments
2016	150	—	US, EU	Launch year; limited penetration
2018	300	100%	US, EU	Steady penetration in refractory mCRC
2020	400	33%	US, EU, Japan	Entry into gastric cancer, expanding indications
2022	575	43.75%	Global	Steady adoption, new regional launches

Note: Consistent YoY growth reflects acceptance in refractory settings, though overall adoption remains concentrated among specialized oncology centers.

2.2. Competitive Positioning

• Main Competitors: Regorafenib (Stivarga), TAS-102 (Lonsurf's active component), Ramucirumab, immunotherapy agents.

• Market Share (2022):	Product	Estimated Market Share	Notes
  Lonsurf	35%	Leading in refractory mCRC
  Regorafenib	30%	Widely used but less tolerated
  TAS-102	20%	Growing but limited in some regions

2.3. Regulatory and Reimbursement Landscape

• US: Reimbursed primarily through Medicare and private payers with noted formulary restrictions.
• Europe: Reimbursement varies by country; NICE in the UK recognized Lonsurf's benefit in 2016, but budget constraints affected prescribing.
• Asia: Market access expanding, especially in Japan, where gastric indications are approved.

2.4. Clinical and Real-World Evidence

• Post-marketing studies highlighted improved survival in refractory mCRC patients, especially those with specific genetic markers (e.g., KRAS mutations).
• Real-world data suggest high adherence rates due to oral administration, improving patient quality of life.

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3. Financial Trajectory and Growth Drivers

3.1. Revenue Forecast (2023–2028)

Year	Estimated Revenue (USD millions)	CAGR (2023–2028)	Assumptions
2023	600	—	Stabilization post-pandemic recovery
2024	640	6.7%	Launch of new regional markets, continuation of current trends
2025	700	9.4%	Expansion into additional indications and countries
2026	800	14.3%	Launch in emerging markets, leveraging combination therapy trials
2027	900	12.5%	Growth driven by clinical pipeline
2028	1,020	13.3%	Market maturity, potential new label expansions

Note: These estimates incorporate pipeline progression, regional market access, and competitive shifts.

3.2. Factors Influencing Revenue

Positive Drivers	Negative/Uncertain Factors
Regulatory approvals in Asia, esp. China	Price erosion if generics or biosimilars enter
Expansion of indications (e.g., earlier lines)	Competitive pressure from novel therapies (immunotherapies, antibody-drug conjugates)
Increasing adoption due to oral convenience	Geographic reimbursement challenges
Combination regimens in development	Potential side effect profile limiting use

3.3. Pipeline and Future Opportunities

• Ongoing trials:
  • Combining Lonsurf with immunotherapies (e.g., PD-1 inhibitors) for synergistic effects.
  • Investigating in adjuvant settings for earlier-stage disease.
• Potential approvals:
  • Expanded indications for gastric or esophageal cancers in more regions.
  • Use in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors.

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4. Market Comparison and Strategic Positioning

Drug	Indications	Approved Regions	Market Share (2022)	Price (USD/tablet)	Delivery Mode	Competitive Edge
Lonsurf	mCRC, gastric	US, EU, Japan	35%	~$100	Oral	Convenience, Evidence in refractory cases
Regorafenib (Stivarga)	mCRC, GIST, HCC	Global	30%	~$70	Oral	Broad indications, fast onset
TAS-102	mCRC	US, EU	20%	~$80	Oral	Proven survival benefit

Key observations:

• Lonsurf maintains a competitive edge in refractory mCRC owing to its efficacy and tolerability profile.
• Entry into earlier lines and new tumor types can destabilize current market shares, emphasizing R&D focus.

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5. Challenges and Opportunities

5.1. Challenges

• Price competition from biosimilars and generics once patents expire.
• Market access barriers in emerging regions due to reimbursement policies.
• Emerging novel therapies—immuno-oncology agents and targeted therapies—may capture market share.
• Limited efficacy in certain patient subgroups, necessitating biomarker-driven prescriptions.

5.2. Opportunities

• Combination therapies: Sy bevestid for expansion into earlier-lined treatments or synergy with immunotherapies.
• Pipeline diversification: Developing next-generation nucleoside analogs or delivery systems.
• Regional expansion: Particularly in Asia-Pacific, leveraging local partnerships and regulatory pathways.
• Biomarker integration: Personalized medicine approaches can improve outcomes and justify premium pricing.

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Key Takeaways

• Market Positioning: Lonsurf is a leading agent in refractory mCRC, with expanding indications and regional access, maintaining a solid revenue base.
• Growth Drivers: Pipeline advances, combination strategies, and regional market penetration are critical for sustained growth in the next five years.
• Competitive Landscape: The drug faces competition from other oral chemotherapies and emerging immunotherapies, necessitating innovation and strategic alliances.
• Financial Outlook: Estimated CAGR of ~10-13% from 2023–2028, driven by pipeline progress and market expansion, offset somewhat by pricing pressures.
• Strategic Considerations: Focus on biomarker-driven personalized therapies, expanding into earlier lines, and geographic diversification will be essential to preserve and grow the market position of Lonsurf.

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FAQs

Q1: What are the primary factors influencing Lonsurf’s sales growth?
A1: Post-approval expansion into additional indications, geographic market penetration, clinical trial outcomes supporting new combinations, and reimbursement policies.

Q2: How does Lonsurf compare to its main competitors in efficacy and tolerability?
A2: Lonsurf offers comparable or superior survival benefits in refractory settings, with a tolerable side effect profile favoring oral administration, though competition is intense from targeted and immunotherapy agents.

Q3: What is the impact of upcoming biosimilars or generics on Lonsurf’s market share?
A3: Patent expirations could lead to price erosion and market share decline unless the company innovates or secures additional patents for new formulations or combinations.

Q4: Are there new indications or combination therapies likely to boost Lonsurf’s revenue?
A4: Yes. Trials exploring combinations with immunotherapies, targeted agents, and potential new indications like adjuvant therapy could significantly elevate revenue streams.

Q5: What regional markets present the greatest growth opportunities for Lonsurf?
A5: Japan, China, and broader Asia-Pacific markets offer substantial growth opportunities owing to high gastric and colorectal cancer incidence and improving regulatory environments.

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References

1. FDA. Lonsurf approval announcement, 2015.
2. EMA. European approval details, 2017.
3. PMDA Japan. Approval for gastric cancer, 2019.
4. IQVIA. Global Oncology Market Reports, 2022.
5. ClinicalTrials.gov. Ongoing Lonsurf combination studies.
6. NICE. Reimbursement decisions for Lonsurf, 2016.

Note: All data and projections are estimates based on current market trends, regulatory landscapes, and pipeline progress as of Q1 2023.