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 eighteen patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for tipiracil hydrochloride; trifluridine

International Patents:	118
US Patents:	6
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Clinical Trials:	57
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
The First Affiliated Hospital with Nanjing Medical University	Phase 2
Sun Yat-sen University	Phase 2
Yonsei University	Phase 1/Phase 2

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
Natco	TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	tipiracil hydrochloride; trifluridine	TABLET;ORAL	214008-002	Jun 13, 2023	AB	RX	No	No
Natco	TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	tipiracil hydrochloride; trifluridine	TABLET;ORAL	214008-001	Jun 13, 2023	AB	RX	No	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	207981-001	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
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	207981-001	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
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
Hong Kong	1203071	地匹福林鹽酸鹽的穩定型晶體及其結晶化方法 (STABILIZED CRYSTAL OF TIPIRACIL HYDROCHLORIDE, AND CRYSTALLIZATION METHOD FOR SAME)
Russian Federation	2674441	СТАБИЛЬНАЯ КРИСТАЛЛИЧЕСКАЯ ФОРМА ТИПИРАЦИЛА ГИДРОХЛОРИДА И СПОСОБ ЕЕ КРИСТАЛЛИЗАЦИИ (STABLE CRYSTALLINE FORM OF TIPIRACIL HYDROCHLORIDE AND METHOD FOR ITS CRYSTALLIZATION)
Australia	2014316030	Antitumor agent and antitumor effect enhancer
Russian Federation	2007132181	ПРОТИВОРАКОВОЕ ЛЕКАРСТВЕННОЕ СРЕДСТВО, СОДЕРЖАЩЕЕ α,α,α-ТРИФТОРТИМИДИН И ИНГИБИТОР ТИМИДИНФОСФОРИЛАЗЫ
Australia	2017208215	Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Canada	2914999	CRISTAL STABILISE DE CHLORHYDRATE DE TIPIRACIL, ET SON PROCEDE DE CRISTALLISATION (STABLE CRYSTAL FORM OF TIPIRACIL HYDROCHLORIDE AND CRYSTALLIZATION METHOD FOR THE SAME)
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	PA2017024,C1849470	Lithuania		PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425
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	34/2017	Austria		PRODUCT NAME: TRIFLURIDIN / TIPIRACIL ODER DEREN PHARMAZEUTISCH WIRKSAMEN SALZE; REGISTRATION NO/DATE: EU/1/16/1096 (MITTEILUNG) 20160427
1849470	SPC/GB17/049	United Kingdom		PRODUCT NAME: TRIFLURIDINE WITH TIPACRIL HYDROCHLORIDE; REGISTERED: UK EU/1/16/1096/001(NI) 20160427; UK EU/1/16/1096/002(NI) 20160427; UK EU/1/16/1096/003(NI) 20160427; UK EU/1/16/1096/004(NI) 20160427; UK EU/1/16/1096/005(NI) 20160427; UK EU/1/16/1096/006(NI) 20160427; UK PLGB 05815/0112 20160427; UK PLGB 05815/0113 20160427
1849470	PA2017024	Lithuania		PRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425
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	2017C/028	Belgium		PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427

Market Dynamics and Financial Trajectory for Trifluridine and Tipiracil Hydrochloride

Introduction

Trifluridine and tipiracil hydrochloride, commonly known by the brand name LONSURF, are pivotal in the treatment of various cancers, particularly colorectal cancer. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this drug.

Market Size and Growth Projections

The Trifluridine and Tipiracil Tablet Market has experienced significant growth in recent years and is projected to continue this trend. By 2031, the market is anticipated to reach a substantial value, driven by increasing demand for effective treatments for colorectal cancer and other tumors[1].

Segmentation of the Market

The market is segmented based on type, application, and geography. The types include 15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil. Applications are primarily in hospitals, pharmacies, and other healthcare settings. Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1].

Drivers of Market Growth

Several factors drive the growth of the Trifluridine and Tipiracil market:

Increasing Prevalence of Colorectal Cancer

Colorectal cancer is one of the most common cancers globally, with approximately 1.9 million new cases and 0.9 million mortalities in 2020. This high incidence rate fuels the demand for effective treatments like trifluridine and tipiracil[3].

Advances in Treatment Methods

The approval of trifluridine and tipiracil with bevacizumab by the FDA for metastatic colorectal cancer has significantly boosted the market. This combination therapy has shown improved overall survival and progression-free survival rates compared to monotherapy[4].

Technological Improvements

Developments in drug delivery technology and ongoing research in antiviral and oncology drugs contribute to the market's growth. These advancements enhance the efficacy and safety of trifluridine and tipiracil, making them more appealing to healthcare providers and patients[5].

Cost-Effectiveness Analysis

A recent study evaluated the cost-effectiveness of trifluridine/tipiracil combined with bevacizumab versus trifluridine/tipiracil monotherapy for colorectal cancer. While the combined treatment offers greater health benefits, its higher cost makes it less cost-effective compared to monotherapy at current willingness-to-pay thresholds[2].

Key Players and Market Competition

Prominent companies such as Taiho Pharmaceutical, Chia Tai Tianqing Pharmaceutical Group, and NATCO Pharma are key players in the Trifluridine and Tipiracil market. These companies have been instrumental in driving market growth through their product offerings and strategic market positioning[1].

Regional Market Dynamics

Asia-Pacific

The Asia-Pacific region is experiencing significant growth due to the increasing demand for treatments of keratoconjunctivitis and epithelial keratitis, as well as the rising prevalence of HSV infections. This region is expected to be a major contributor to the overall market growth[5].

North America

North America holds a significant market share due to the presence of major pharmaceutical companies and the high prevalence of eye infections. The growing awareness and demand for effective antiviral drugs further drive the market in this region[5].

Financial Trajectory

The financial trajectory of the Trifluridine and Tipiracil market is robust, with projections indicating sustained growth from 2023 to 2031. The market size is expected to increase substantially, driven by the factors mentioned above.

Revenue Projections

The market is anticipated to grow at a significant CAGR, reaching a substantial value by the end of the forecast period. This growth is supported by the increasing demand for the drug and the expanding geographical reach[1].

Investment and Research

The development of new antiviral and oncology drugs, including trifluridine and tipiracil, involves significant investment. The cost of developing new antiviral drugs can range from $800 million to over $2.5 billion, highlighting the financial commitment required to bring these treatments to market[5].

Challenges and Opportunities

Challenges

Despite the growth, the market faces challenges such as high development costs and the risk of drug candidates failing during clinical trials. Approximately nine out of ten drug candidates that enter clinical trials will fail, which can impact market dynamics[5].

Opportunities

The increasing awareness of eye health and the growing demand for effective antiviral drugs present significant opportunities for market expansion. Additionally, the approval of new treatment combinations, such as trifluridine and tipiracil with bevacizumab, opens up new avenues for growth[4].

Regulatory Approvals and Clinical Trials

The FDA approval of trifluridine and tipiracil with bevacizumab for metastatic colorectal cancer is a significant milestone. Clinical trials, such as the SUNLIGHT trial, have demonstrated the efficacy and safety of this combination, further solidifying its market position[4].

Safety and Efficacy

The safety and efficacy of trifluridine and tipiracil have been extensively evaluated. The most common adverse reactions include neutropenia, anemia, thrombocytopenia, fatigue, and nausea. Despite these side effects, the overall survival and progression-free survival benefits make it a valuable treatment option[4].

Conclusion

The market for trifluridine and tipiracil hydrochloride is poised for significant growth, driven by increasing demand for effective cancer treatments, technological advancements, and regulatory approvals. While challenges exist, the opportunities in this market are substantial, making it an attractive sector for investment and research.

Key Takeaways

• The Trifluridine and Tipiracil Tablet Market is expected to grow substantially by 2031.
• The market is driven by the increasing prevalence of colorectal cancer and advancements in treatment methods.
• Key players such as Taiho Pharmaceutical and NATCO Pharma are instrumental in market growth.
• The Asia-Pacific and North America regions are significant contributors to the market.
• Regulatory approvals, such as the FDA approval of trifluridine and tipiracil with bevacizumab, are crucial for market expansion.

FAQs

What is the primary use of trifluridine and tipiracil hydrochloride?

Trifluridine and tipiracil hydrochloride are primarily used in the treatment of metastatic colorectal cancer and other tumors.

Which regions are expected to drive the growth of the trifluridine and tipiracil market?

The Asia-Pacific and North America regions are expected to be major drivers of market growth due to increasing demand and the presence of key pharmaceutical companies.

What are the common adverse reactions associated with trifluridine and tipiracil?

Common adverse reactions include neutropenia, anemia, thrombocytopenia, fatigue, nausea, and increased liver enzymes.

Has the FDA approved trifluridine and tipiracil with bevacizumab?

Yes, the FDA approved trifluridine and tipiracil with bevacizumab for metastatic colorectal cancer in August 2023[4].

What is the cost-effectiveness of trifluridine/tipiracil combined with bevacizumab?

The combination of trifluridine/tipiracil with bevacizumab is not cost-effective compared to trifluridine/tipiracil monotherapy at current willingness-to-pay thresholds[2].

Sources

1. Market Research Intellect, "Trifluridine and Tipiracil Tablet Market Size, Scope And Forecast," December 2024.
2. PubMed, "Cost-effectiveness analysis of trifluridine/tipiracil combined with bevacizumab vs. trifluridine/tipiracil monotherapy," November 2024.
3. OMR Global, "Global Trifluridine API Market Size, Industry Trends & Forecast to 2031," November 2024.
4. FDA, "FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer," August 2023.
5. GII Research, "Global Trifluridine API Market 2024-2031," November 2024.

Last updated: 2024-12-17