TRIFLURIDINE - Generic Drug Details

What are the generic sources for trifluridine and what is the scope of freedom to operate?

Trifluridine is the generic ingredient in two branded drugs marketed by Hikma, Sandoz, and Monarch Pharms, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for trifluridine. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for TRIFLURIDINE

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	65
Patent Applications:	6,808
Drug Prices:	Drug price trends for TRIFLURIDINE
What excipients (inactive ingredients) are in TRIFLURIDINE?	TRIFLURIDINE excipients list
DailyMed Link:	TRIFLURIDINE at DailyMed

See drug prices for TRIFLURIDINE

Recent Clinical Trials for 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 TRIFLURIDINE clinical trials

Generic filers with tentative approvals for TRIFLURIDINE

Applicant	Application No.	Strength	Dosage Form
		20MG/8.19MG	TABLET;ORAL
		15MG/6.14MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for TRIFLURIDINE

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

Medical Subject Heading (MeSH) Categories for TRIFLURIDINE

Antimetabolites

Antiviral Agents

Anatomical Therapeutic Chemical (ATC) Classes for TRIFLURIDINE

S01AD	Antivirals
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for TRIFLURIDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	TRIFLURIDINE	trifluridine	SOLUTION/DROPS;OPHTHALMIC	205438-001	Jul 28, 2017		DISCN	No	No
Monarch Pharms	VIROPTIC	trifluridine	SOLUTION/DROPS;OPHTHALMIC	018299-001	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes
Sandoz	TRIFLURIDINE	trifluridine	SOLUTION/DROPS;OPHTHALMIC	074311-001	Oct 6, 1995	AT	RX	No	No

TRIFLURIDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trifluridine (Lonsurf)

Overview of Trifluridine and Tipiracil

Trifluridine, in combination with tipiracil, is marketed as Lonsurf and is approved for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with various chemotherapies and biological therapies[4].

Market Size and Growth Projections

The market for trifluridine and tipiracil tablets is expected to exhibit significant growth over the forecast period from 2023 to 2031. This growth is driven by the increasing demand for effective treatments for metastatic colorectal cancer.

• The global trifluridine and tipiracil tablet market is anticipated to grow at a remarkable CAGR, reflecting exponential market growth during the forecast period[2].
• The market size is projected to increase substantially, with the market valued in USD millions across various segments, including type (15 mg trifluridine/6.14 mg tipiracil and 20 mg trifluridine/8.19 mg tipiracil) and application (hospital, pharmacy, and other settings)[2].

Key Market Segments

The market is segmented based on several factors:

• Type: The market is categorized into two main types: 15 mg trifluridine/6.14 mg tipiracil and 20 mg trifluridine/8.19 mg tipiracil[2].
• Application: The primary applications include hospitals, pharmacies, and other healthcare settings[2].
• Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[2].

Financial Trajectory

Cost-Effectiveness Analysis

The financial viability of trifluridine-tipiracil, especially when combined with bevacizumab, is a critical aspect of its market dynamics.

• The incremental cost-effectiveness ratio (ICER) for trifluridine-tipiracil plus bevacizumab compared to best supportive care (BSC) was estimated to be around $195,000 per quality-adjusted life-year (QALY) gained in one analysis. This is significantly higher than the commonly accepted threshold of $50,000 per QALY gained[1].
• For the regimen to be considered cost-effective at a $50,000 per QALY threshold, a substantial price reduction of 77.2% would be necessary for all components of the regimen[1].

Market Size and Revenue

The metastatic colorectal cancer market, within which trifluridine-tipiracil operates, was valued at USD 15 billion in 2022 and is expected to grow at a significant CAGR from 2019 to 2032[3].

• The growth in the colorectal cancer treatment market is driven by the increasing incidence of the disease, the development of new therapies, and improvements in diagnosis rates[3].

Drivers and Restraints

Drivers

• Emerging Therapies: The robust pipeline of colorectal cancer treatments, including mutation-specific therapies, is expected to drive market growth. Approvals of new therapies like KEYTRUDA, OPDIVO, and BRAFTOVI have set a precedent for future treatments[3].
• Increasing Demand: The need for effective treatments for metastatic colorectal cancer continues to drive demand for drugs like trifluridine-tipiracil[2].

Restraints

• Economic Burden: The high cost of colorectal cancer treatments, including trifluridine-tipiracil, poses a significant economic burden on patients and healthcare systems. This can limit market growth due to affordability issues and reimbursement challenges[3].
• Regulatory and Reimbursement Issues: Inconsistent adherence to treatment guidelines and market access issues can impede the growth of the market[3].
• Side Effects and Quality of Life: The impact of adverse events on quality of life can also affect the cost-effectiveness and patient acceptance of the treatment[1].

Patient Access and Support Programs

To mitigate some of the financial and access barriers, pharmaceutical companies have implemented various support programs.

• Co-Pay Reductions: Taiho Oncology has eliminated co-pays for commercially insured patients, reducing the financial burden on those undergoing treatment with Lonsurf. Additionally, the company offers a Patient Assistance Program for patients without insurance or those who are underinsured[5].

Competitive Landscape

The market for colorectal cancer treatments is highly competitive, with several key players:

• Established Players: Companies like Pfizer, Sanofi, Taiho Pharma, and Ono Pharma are major players in the market[3].
• Emerging Players: New entrants such as Hutchison Medipharma, Isofol Medical, Sumitomo Dainippon Pharma, and others are expected to change the market dynamics with their emerging pipeline candidates[3].

Mechanism of Action and Clinical Benefits

Trifluridine acts as a thymidine-based nucleoside metabolic inhibitor that is incorporated into the DNA of cancer cells, disrupting DNA function during cell replication. When combined with tipiracil, it has shown increased progression-free survival (PFS), overall response rate (ORR), and disease control rate (DCR) compared to placebo in clinical studies[4].

Key Takeaways

• The trifluridine and tipiracil market is poised for significant growth driven by increasing demand and the development of new therapies.
• The cost-effectiveness of the treatment, especially when combined with bevacizumab, remains a challenge and requires substantial price reductions to meet common cost-effectiveness thresholds.
• Patient support programs and co-pay reductions are crucial in improving access to the treatment.
• The competitive landscape is dynamic, with both established and emerging players contributing to market growth.

FAQs

1. What is the primary use of trifluridine-tipiracil (Lonsurf)? Trifluridine-tipiracil (Lonsurf) is primarily used for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with various chemotherapies and biological therapies[4].

2. What are the key drivers of the trifluridine-tipiracil market? The market is driven by the increasing demand for effective treatments for metastatic colorectal cancer, the development of new therapies, and improvements in diagnosis rates[2][3].

3. What are the main challenges to the cost-effectiveness of trifluridine-tipiracil plus bevacizumab? The main challenges include high drug acquisition costs, resulting in an ICER that is significantly higher than commonly accepted thresholds, and the need for substantial price reductions to achieve cost-effectiveness[1].

4. How do patient support programs impact the market? Patient support programs, such as co-pay reductions and patient assistance programs, help improve access to the treatment by reducing the financial burden on patients[5].

5. Who are the key players in the colorectal cancer treatment market? Key players include established companies like Pfizer, Sanofi, and Taiho Pharma, as well as emerging players such as Hutchison Medipharma and Isofol Medical[3].

Sources

1. Pharmacoeconomic Review - Trifluridine-Tipiracil (Lonsurf) - NCBI
2. Global Trifluridine and Tipiracil Tablet Market Size, Trends and ... - Market Research Intellect
3. Colorectal Cancer Treatment Drug Market to Show Immense Growth ... - DelveInsight
4. Trifluridine: Uses, Interactions, Mechanism of Action | DrugBank Online
5. Taiho Oncology Eliminates Co-Pays for Many of the Patients Treated ... - NCODA