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 eighteen patent family members in thirty-three 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:	118
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	55
Patent Applications:	552
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
Yonsei University	Phase 1/Phase 2
Taiho	Phase 2
Amgen	Phase 3

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	RE46284
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No	10,456,399
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes	RE46284
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes	10,457,666		Y	Y
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	AB	RX	Yes	No	9,943,537
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	AB	RX	Yes	Yes	9,943,537

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	5,744,475
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	5,744,475
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-001	Sep 22, 2015	6,479,500
Taiho Oncology	LONSURF	tipiracil hydrochloride; trifluridine	TABLET;ORAL	207981-002	Sep 22, 2015	6,479,500

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

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
Lithuania	C1849470
Russian Federation	2016100972	СТАБИЛЬНАЯ КРИСТАЛЛИЧЕСКАЯ ФОРМА ТИПИРАЦИЛА ГИДРОХЛОРИДА И СПОСОБ ЕЕ КРИСТАЛЛИЗАЦИИ
Luxembourg	C00036
South Korea	20070104559	ANTICANCER DRUG CONTAINING alpha;,alpha;,alpha;-TRIFLUOROTHYMIDINE AND THYMIDINE PHOSPHORYLASE INHIBITOR
Japan	WO2017135412	重度腎機能障害を有する癌患者に対する治療方法
Ukraine	112626	СТАБІЛЬНА КРИСТАЛІЧНА ФОРМА ТИПІРАЦИЛУ ГІДРОХЛОРИДУ І СПОСІБ ЇЇ КРИСТАЛІЗАЦІЇ

Supplementary Protection Certificates for LONSURF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1849470	1790063-0	Sweden		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/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	300889	Netherlands		PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470	322 20-2017	Slovakia		PRODUCT NAME: TRIFLURIDIN/TIPIRACIL VO VSETKYCH FORMACH CHRA- NENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: 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	17C1028	France		PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427

Market Dynamics and Financial Trajectory for Lonsurf

Last updated: July 3, 2025

Introduction to Lonsurf

Lonsurf, a combination of trifluridine and tipiracil, stands out as a critical treatment for patients with metastatic colorectal cancer and certain gastric cancers. First approved by the U.S. Food and Drug Administration (FDA) in 2015, this oral chemotherapy agent inhibits cancer cell growth by disrupting DNA synthesis. Taiho Pharmaceutical, in partnership with Servier, drives its development and commercialization, targeting markets where advanced oncology therapies command premium pricing. As demand for personalized cancer treatments rises, Lonsurf exemplifies how targeted drugs navigate complex regulatory pathways to reach global patients.

Current Market Dynamics

The oncology market surges amid rising cancer incidences, with Lonsurf carving a niche in the colorectal cancer segment. Global colorectal cancer cases topped 1.9 million in 2020, according to the World Health Organization, fueling demand for late-line therapies like Lonsurf. This drug primarily serves patients who have exhausted standard treatments, positioning it in a high-value market estimated at $20 billion annually by IQVIA data.

Market growth for Lonsurf hinges on expanding indications and geographic reach. In 2023, sales expanded in Europe and Asia-Pacific regions, driven by Servier's distribution efforts. However, supply chain disruptions and pricing pressures in emerging markets temper this momentum. Competitors such as Bristol Myers Squibb's Opdivo and Merck's Keytruda erode market share by offering immunotherapy alternatives, yet Lonsurf maintains an edge through its proven efficacy in refractory cases. Analysts note that Lonsurf's market penetration correlates with healthcare spending; for instance, U.S. adoption outpaces that in cost-sensitive regions like Latin America.

Competitive Landscape

Lonsurf faces stiff competition in the metastatic colorectal cancer space, where innovation accelerates. Key rivals include Regeneron and Sanofi's Zaltrap and Amgen's Vectibix, both targeting similar patient populations. Unlike these biologics, Lonsurf's small-molecule formulation offers oral administration convenience, appealing to patients fatigued by infusion therapies. Market data from Evaluate Pharma indicates Lonsurf captured approximately 5% of the global metastatic colorectal cancer market in 2022, with projections for 7% growth by 2027 as clinical trials expand its use.

Strategic alliances bolster Lonsurf's position. Taiho's collaboration with Servier extends to over 70 countries, enabling rapid market entry and localized pricing strategies. Yet, biosimilar threats loom as patents expire; for example, generic entrants could disrupt pricing post-2029, based on current intellectual property timelines. This dynamic forces Taiho to innovate, with ongoing trials exploring Lonsurf combinations with immunotherapies to differentiate it further.

Regulatory and Patent Landscape

Regulatory approvals shape Lonsurf's trajectory, with the FDA and European Medicines Agency (EMA) granting it orphan drug status for gastric cancer in 2019. This designation accelerates review processes and provides market exclusivity, shielding Lonsurf from generics until patent cliffs. Taiho holds core patents on trifluridine/tipiracil formulations until 2028 in major markets, as per USPTO records, but extensions via pediatric exclusivity could push this to 2030.

Globally, varying regulations impact accessibility. In China, the National Medical Products Administration approved Lonsurf in 2021, opening a market of over 400,000 annual colorectal cancer cases. However, stringent pricing negotiations under China's National Reimbursement Drug List delay widespread adoption. These factors underscore the need for adaptive strategies, as regulatory hurdles in developing regions could limit Lonsurf's financial upside despite its clinical benefits.

Financial Performance and Trajectory

Lonsurf's financial story reflects broader pharmaceutical trends, with revenues climbing from $500 million in 2020 to over $800 million in 2023, per Taiho's financial filings. This growth stems from expanded indications and robust U.S. sales, where it generates nearly 60% of total revenue. Net profits, however, fluctuate due to high R&D costs; Taiho reported a 15% operating margin in 2023, bolstered by cost efficiencies in manufacturing.

Forecasts from Bloomberg Intelligence project Lonsurf revenues to reach $1.2 billion by 2026, driven by market expansion in Asia and potential label extensions. Yet, patent expirations pose risks; analysts estimate a 20-30% revenue drop post-2029 without new protections. Taiho counters this by investing in pipeline drugs, allocating 25% of 2023 profits to R&D. Investor sentiment remains positive, with Taiho's stock rising 18% year-to-date on Lonsurf's performance, though macroeconomic factors like inflation could squeeze margins.

Future Outlook

Looking ahead, Lonsurf's market dynamics will pivot on clinical trial outcomes and global health policies. Phase III trials combining Lonsurf with pembrolizumab could double its addressable market by 2025, targeting earlier-stage patients. Financially, Taiho aims for sustained growth through acquisitions, potentially acquiring complementary assets to offset Lonsurf's lifecycle risks. However, geopolitical tensions and currency fluctuations in key markets like Japan and the EU may introduce volatility.

Experts predict a compound annual growth rate of 12% for Lonsurf through 2030, per Statista projections, assuming successful navigation of patent challenges. This trajectory positions Lonsurf as a bellwether for oral oncology drugs, where innovation meets fiscal discipline in an era of rising healthcare costs.

Key Takeaways

• Lonsurf drives significant revenue for Taiho, with 2023 sales exceeding $800 million, but faces threats from patent expirations around 2029.
• The drug maintains a competitive edge in metastatic colorectal cancer through its oral format and expanding indications, capturing about 5% of the global market.
• Regulatory approvals and partnerships enhance accessibility, yet pricing pressures in emerging markets could limit growth.
• Financial projections forecast revenues up to $1.2 billion by 2026, contingent on trial successes and market expansions.
• Investors should monitor R&D investments and competitive entries to gauge long-term sustainability.

FAQs

1. What is Lonsurf primarily used for?
Lonsurf treats metastatic colorectal cancer and certain gastric cancers in patients who have failed prior therapies, offering an oral alternative to traditional infusions.

2. How does Lonsurf's patent status affect its market?
Core patents expire around 2028-2030, potentially allowing generics to enter and reduce prices, which could erode Taiho's market share without new innovations.

3. What factors drive Lonsurf's revenue growth?
Revenue growth stems from expanded geographic sales, new indications from clinical trials, and strategic partnerships, with U.S. markets contributing the majority.

4. Who are Lonsurf's main competitors?
Key competitors include Opdivo from Bristol Myers Squibb and Keytruda from Merck, which offer immunotherapy options for similar cancer indications.

5. What risks could impact Lonsurf's financial trajectory?
Patent cliffs, regulatory delays in key regions, and competition from biosimilars pose significant risks, potentially leading to revenue declines post-2029.

Sources

1. Taiho Pharmaceutical. Annual Financial Report 2023. Available at: Taiho investor relations portal.
2. IQVIA Institute. Global Oncology Trends 2023 Report. Available at: IQVIA publications.
3. Evaluate Pharma. World Preview 2024, Outlook to 2030. Available at: Evaluate Pharma database.
4. United States Patent and Trademark Office (USPTO). Patent details for trifluridine/tipiracil formulations. Available at: USPTO search.
5. Statista. Pharmaceutical Market Insights Report 2023. Available at: Statista platform.
6. Bloomberg Intelligence. Oncology Sector Analysis, February 2024. Available at: Bloomberg terminal access.