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Last Updated: December 22, 2024

TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE Drug Patent Profile


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Which patents cover Tipiracil Hydrochloride And Trifluridine, and what generic alternatives are available?

Tipiracil Hydrochloride And Trifluridine is a drug marketed by Natco and is included in one NDA.

The generic ingredient in TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE 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 Tipiracil Hydrochloride And Trifluridine

A generic version of TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE was approved as tipiracil hydrochloride; trifluridine by NATCO on June 13th, 2023.

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Summary for TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 57
DailyMed Link:TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE at DailyMed
Drug patent expirations by year for TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE
Recent Clinical Trials for TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE

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

SponsorPhase
The First Affiliated Hospital with Nanjing Medical UniversityPhase 2
Sun Yat-sen UniversityPhase 2
Yonsei UniversityPhase 1/Phase 2

See all TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE clinical trials

US Patents and Regulatory Information for TIPIRACIL HYDROCHLORIDE AND 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 214008-001 Jun 13, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Natco TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE tipiracil hydrochloride; trifluridine TABLET;ORAL 214008-002 Jun 13, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tipiracil Hydrochloride and Trifluridine

Introduction to Tipiracil Hydrochloride and Trifluridine

Tipiracil hydrochloride and trifluridine, combined under the brand name LONSURF, are key components of an oral anticancer drug developed by Taiho Pharmaceutical Co., Ltd. This drug is designed to treat various types of cancer, including metastatic colorectal cancer (mCRC) and metastatic gastric cancer[2].

Mechanism of Action and Clinical Indications

The mechanism of action of LONSURF involves trifluridine (FTD), an antineoplastic nucleoside analogue, which is incorporated into DNA to interfere with its function. Tipiracil hydrochloride (TPI) inhibits the FTD-degrading enzyme thymidine phosphorylase, thereby maintaining the blood concentration of FTD. This dual mechanism enhances the efficacy of the treatment[2].

Market Size and Growth Projections

The market for trifluridine and tipiracil tablets 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, with a notable increase from its 2023 levels. This growth is driven by the increasing demand for effective treatments for various types of cancer and other conditions such as herpes simplex keratitis[1][3].

Market Segmentation

The market is segmented based on several factors, including:

Type

  • The drug is available in different dosages, such as 15 mg trifluridine/6.14 mg tipiracil and 20 mg trifluridine/8.19 mg tipiracil[1].

Application

  • The primary applications include hospitals, pharmacies, and other healthcare settings[1].

Geographical Regions

  • The market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1].

Drivers of Market Growth

Several factors are driving the growth of the trifluridine and tipiracil market:

Increasing Incidence of Cancer

  • The rising incidence of colorectal and gastric cancers globally is a significant driver. For instance, colorectal cancer was the third most common cancer in males and the second most common in females in 2020, with approximately 1.9 million new cases and 0.9 million mortalities worldwide[3].

Advances in Treatment Methods

  • Developments in treatment methods and drug delivery technologies are enhancing the efficacy and accessibility of trifluridine and tipiracil, contributing to market growth[5].

Growing Demand for Antiviral Drugs

  • The increasing demand for antiviral drugs, particularly for treating herpes simplex virus (HSV) infections, is another key factor. An estimated 3.7 billion people under the age of 50 globally have HSV type 1 (HSV-1) infection, driving the need for effective antiviral treatments like trifluridine[5].

Market Dynamics

Market Opportunities

  • The growing awareness of eye health and the need for efficient treatments for conditions like herpetic keratitis present significant opportunities for the trifluridine and tipiracil market[5].

Market Challenges

  • Despite the growth, the market faces challenges such as high development costs for new antiviral drugs, which can range from $800 million to over $2.5 billion. Additionally, the failure rate of drug candidates in clinical trials is high, with approximately nine out of ten candidates failing[5].

Financial Trajectory

Revenue Projections

  • The market is expected to achieve substantial revenue growth from 2023 to 2031, driven by the increasing demand and expanding applications of the drug[1].

Cost-Effectiveness Analysis

  • Studies have evaluated the cost-effectiveness of combining trifluridine/tipiracil with bevacizumab versus monotherapy. While the combination treatment offers greater health benefits, it is more expensive and may not be cost-effective in all scenarios, as indicated by a study in the Chinese healthcare system[4].

Regional Market Analysis

Asia-Pacific

  • This region is experiencing significant growth due to the increasing demand for treating keratoconjunctivitis and epithelial keratitis, driven by the rising prevalence of HSV infections. For example, in Asia, 50% of children and 75% of adults are infected with HSV-1[5].

North America

  • North America holds a major market share due to the high incidence of cancer and the advanced healthcare infrastructure, which facilitates the adoption of new treatments[5].

Key Players and Competitive Landscape

The market for trifluridine and tipiracil is dominated by key players such as Taiho Pharmaceutical Co., Ltd., which developed LONSURF. Other companies, like Santiago lab, are also involved in providing trifluridine API-based antiviral drugs, contributing to the competitive landscape[2][5].

Economic and Regulatory Factors

Legal Frameworks

  • The market is influenced by legal frameworks and regulatory approvals. The approval and licensing of LONSURF have been critical in its market success[2].

Economic Impact

  • The economic impact of the drug is significant, with high development costs and varying cost-effectiveness across different treatment regimens. The cost of treatment, such as the combination of trifluridine/tipiracil with bevacizumab, can be substantial, affecting its adoption in different healthcare systems[4].
"Approximately nine out of 10 drug candidates that enter clinical trials will fail during clinical trials."[5]

Consumer Behavior and Healthcare Trends

Increasing Awareness of Health

  • The growing awareness of health, particularly eye health, is driving the demand for effective treatments like trifluridine and tipiracil. Consumers are increasingly seeking advanced and efficient treatments, which is a positive trend for the market[5].

Technological Advancements

  • Advances in drug delivery technology and ongoing research and development in trifluridine API are enhancing the market's growth potential. These advancements improve the efficacy and accessibility of the drug, making it more appealing to consumers[5].

Conclusion

The market for tipiracil hydrochloride and trifluridine is poised for significant growth, driven by increasing demand for cancer treatments, advances in technology, and growing awareness of health. However, the market also faces challenges such as high development costs and varying cost-effectiveness.

Key Takeaways

  • The trifluridine and tipiracil market is expected to grow substantially from 2023 to 2031.
  • The drug's dual mechanism of action enhances its efficacy in treating various types of cancer.
  • The market is driven by increasing cancer incidence, advances in treatment methods, and growing demand for antiviral drugs.
  • Regional growth varies, with Asia-Pacific and North America being key markets.
  • High development costs and clinical trial failure rates are significant challenges.

FAQs

What is the primary use of tipiracil hydrochloride and trifluridine?

The primary use of tipiracil hydrochloride and trifluridine, under the brand name LONSURF, is to treat various types of cancer, including metastatic colorectal cancer (mCRC) and metastatic gastric cancer.

What is the mechanism of action of LONSURF?

LONSURF works through trifluridine, which is incorporated into DNA to interfere with its function, and tipiracil, which inhibits the FTD-degrading enzyme thymidine phosphorylase, maintaining the blood concentration of FTD.

What are the key drivers of the trifluridine and tipiracil market?

Key drivers include the increasing incidence of cancer, advances in treatment methods, and growing demand for antiviral drugs, particularly for treating herpes simplex virus (HSV) infections.

How is the market segmented?

The market is segmented based on type (different dosages), application (hospitals, pharmacies, etc.), and geographical regions (North America, Europe, Asia-Pacific, etc.).

What are the challenges faced by the trifluridine and tipiracil market?

Challenges include high development costs for new antiviral drugs, high failure rates of drug candidates in clinical trials, and varying cost-effectiveness of different treatment regimens.

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

Asia-Pacific and North America are expected to be key drivers of market growth due to increasing demand and advanced healthcare infrastructure.

Sources:

  1. Market Research Intellect, "Trifluridine and Tipiracil Tablet Market Size, Scope And Forecast"
  2. Drug Patent Watch, "Lonsurf Market dynamics and financial trajectory"
  3. OMR Global, "Global Trifluridine API Market Size, Industry Trends & Forecast to 2031"
  4. PubMed, "Cost-effectiveness analysis of trifluridine/tipiracil combined with bevacizumab vs. trifluridine/tipiracil monotherapy"
  5. GII Research, "Global Trifluridine API Market 2024-2031"

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