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-three 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:	123
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	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

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

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
Cyprus	1124868
Japan	2000273044	REDUCING AGENT FOR ADVERSE EFFECT
Finland	3042669
Taiwan	I791430

Supplementary Protection Certificates for LONSURF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1849470	17C1028	France		PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470	PA2017024	Lithuania		PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425
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	1790063-0	Sweden		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427

Market Dynamics and Financial Trajectory for LONSURF (trifluridine/triphosphate + tipiracil)

Last updated: March 10, 2026

What is the current market size and growth for LONSURF?

LONSURF, developed by Taiho Oncology, is approved for metastatic colorectal cancer (mCRC) treatment. As of 2022, the global colorectal cancer therapeutics market was valued at approximately $7.4 billion, with LONSURF contributing a substantial share in the niche targeted therapy segment. Market growth projections estimate an annual compound growth rate (CAGR) of 8-10% through 2027, driven primarily by increasing mCRC prevalence and evolving treatment guidelines.

North America accounted for roughly 45% of the market in 2022, with Europe representing another 30%. The Asia-Pacific region demonstrates the fastest growth, with CAGR exceeding 12%, due to rising healthcare investments and cancer screening initiatives.

How does LONSURF’s sales perform financially?

In fiscal year 2022, Taiho reported LONSURF net sales of approximately $350 million globally, with the U.S. contributing $180 million and Japan about $70 million. Sales in Europe and other markets collectively totaled the remaining $100 million. The compound annual growth from 2019 to 2022 averaged 20%, fueled by expanding indications and continued approval in multiple jurisdictions.

LONSURF’s revenue growth is tempered by market access challenges, including payer coverage restrictions and competition from existing standard-of-care therapies like regorafenib and TAS-102, as well as emerging treatments like anti-EGFR and immunotherapies.

What are the key drivers influencing future market dynamics?

Regulatory approvals: Continued expansions into second-line and potentially adjuvant settings could broaden its usage. Recently, approval in China for pretreated mCRC marked an entry into a large, rapidly growing market.

Market penetration strategies: Taiho’s collaborations with healthcare providers and payers influence adoption rates. The company’s efforts to demonstrate cost-effectiveness have improved formulary inclusion in key markets.

Competitive landscape: The introduction of newer agents, especially immunotherapy combinations and targeted therapies, will impact LONSURF's market share. The expiration of patents or exclusivity periods in select regions could open generic competition and reduce prices.

Clinical trial outcomes: Ongoing studies assessing LONSURF's efficacy in earlier lines of therapy, as well as in combination with other agents, could expand its labeled indications. Positive results may increase prescriptions and revenue streams.

Pricing policies: Adjustments based on regional healthcare policies and negotiations affect profitability. The U.S. Medicare and private insurer negotiations directly influence net sales.

What are the expected financial trajectories?

Analysts project LONSURF’s global sales to grow at a CAGR of 12-15% over the next five years, reaching approximately $1 billion by 2028. This forecast accounts for:

• Expanded approvals in Asia and Europe.
• Entry into earlier treatment lines, pending ongoing clinical trial success.
• Increased market penetration driven by competitive pricing and formulation improvements.

However, market constraints like scaling generic competition, payer access limitations, and regional regulatory hurdles could temper growth.

How do regional policies impact LONSURF’s market trajectory?

• United States: Reimbursement via Medicare Part B and commercial payers. CMS negotiations on drug pricing influence profitability.
• Europe: Variability in health technology assessments (HTA) processes; some countries favor cost-effective treatments, impacting uptake.
• Japan: Early approval and reimbursement facilitate rapid market penetration. Recent price negotiations have stabilized revenue streams.
• China: Rapid market expansion following recent approvals; government policies favor innovative therapies to combat rising cancer incidence.

What are the risks affecting future financial trajectory?

• Regulatory delays or rejections in new indications.
• Competitive pressure from emerging therapies with superior efficacy profiles.
• External factors such as shifts in global healthcare budgets or reimbursement policies.
• Patent expirations and potential for generic versions in key markets.

Key Takeaways

• LONSURF’s global sales increased significantly over recent years, with revenues reaching approximately $350 million in 2022.
• The market for colorectal cancer drugs is expanding, driven by rising incidence and improving survival rates.
• Future growth hinges on expanding indications, clinical outcomes, and regional access policies.
• Competitive threats and patent expirations could influence the trajectory.
• Strategic collaborations and clinical trial successes remain vital to sustaining growth.

FAQs

1. Will LONSURF be approved for earlier lines of therapy?
Pending results from ongoing trials; approval is possible if data show improved outcomes in first- or second-line settings.

2. How does the entry of biosimilars or generics impact LONSURF’s revenue?
Patent expiry or loss of exclusivity could lead to price erosion and reduced market share, particularly in the U.S. and Europe.

3. What competitive therapies threaten LONSURF’s market position?
Regorafenib, TAS-102, emerging immunotherapy combinations, and targeted agents are primary competitors.

4. How does regional healthcare policy affect drug pricing and sales?
Pricing negotiations, HTA assessments, and reimbursement levels directly influence revenue potential in each market.

5. What is the long-term outlook for LONSURF’s growth?
Sustained growth depends on regulatory approvals, clinical success, market access, and competitive landscape evolution over the next five years.

References

1. Markets and Markets. (2022). Colorectal Cancer Therapeutics Market.
2. Taiho Oncology. (2022). LONSURF Financial Reports.
3. GlobalData. (2022). Oncology Drug Market Outlook.
4. U.S. Food and Drug Administration. (2015). LONSURF approval documentation.
5. European Medicines Agency. (2022). Post-authorization updates for LONSURF.