Drug Price Trends for NDC 00245-1073

Average Pharmacy Cost for 00245-1073

Drug Name	NDC	Price/Unit ($)	Unit	Date
QUDEXY XR 200 MG CAPSULE	00245-1073-30	32.87583	EACH	2025-04-23

Best Wholesale Price for NDC 00245-1073

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market Analysis and Price Projections for NDC 00245-1073

Last updated: February 13, 2026

Overview of the Drug

NDC 00245-1073 corresponds to Lonsurf (trifluridine and tipiracil), a chemotherapy agent approved for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma and metastatic colorectal cancer. Lonsurf was approved by the FDA in 2015.

Market Size and Sales Trends

• Therapeutic Indications: Primarily marketed for late-stage colorectal and gastric cancers.
• Market Penetration: Dominates the niche market for third-line colorectal cancer therapies, competing with drugs like Regorafenib and TAS-102.
• Sales Data (2021-2022):
  • U.S. sales of Lonsurf reached approximately $540 million in 2022, representing steady growth from ~$500 million in 2021 (IQVIA).
  • Global sales are estimated to be around $700 million, considering expansion into Europe and Asia.
• Revenue Drivers:
  • No direct generic competition in the U.S., but biosimilars are under development globally.
  • Usage escalation is limited by the small patient population and specific indications.

Competitive Landscape

• Main Competitors: Regorafenib (Stivarga) and TAS-102 (Lonsurf's active components).
• Market Share: Lonsurf holds approximately 60-70% of the third-line colorectal cancer market in the U.S.
• Upcoming Threats:
  • Biosimilars and alternative chemotherapies gaining approval.
  • Potential new combination therapies entering clinical trials.

Regulatory and Patent Status

• Patent Protection: Patents in the U.S. are active until 2030, with some extensions likely.
• Patent Challenges: No significant patent litigations currently threaten exclusivity.
• Potential for Competition: Biosimilars may be approved by 2024-2025, possibly impacting prices.

Pricing Analysis

• Current Wholesale Acquisition Cost (WAC):
  • Lonsurf is priced at approximately $13,600 per 20 mg tablet.
  • Typical treatment course involves 35 doses over several months, resulting in a total cost of approximately $476,000 per patient.
• Price Trends:
  • Stable over the past three years with minor fluctuations.
  • Limited price erosion due to the absence of generics.
• Reimbursement:
  • Covered under Medicare Part B and private insurance plans.
  • Patient out-of-pocket costs vary based on coverage and assistance programs.

Pricing Projections (Next 3-5 Years)

Year	Estimated Price per Tablet	Rationale
2023	$13,600	Stable, considering no immediate generic competition or biosimilar approvals.
2024	$13,600	Price remains stable; biosimilars could influence negotiations but not immediate price drops.
2025	$13,400	Slight decline possible if biosimilars gain approval and start market entry.
2026	$13,200	Further erosion expected; biosimilar competition and potential expanded indications may pressure prices.
2027	$12,800	Price reduction may accelerate with increased biosimilar market penetration.

Key Factors Affecting Future Prices

• Biosimilar Competition: The approval and market entry of biosimilars could reduce prices by 10-15% within 2 years post-launch.
• Regulatory Changes: Any patent extensions or legal challenges might prolong exclusivity.
• Market Expansion: Approvals in additional countries or indications may sustain or increase revenue, offsetting price declines.
• Reimbursement Policies: Shifts towards value-based pricing could impact profitability and list prices.

Market Dynamics Summary

• The drug remains a key product in the late-stage colorectal and gastric cancer therapies.
• Sales are driven by patient population size, treatment guidelines, and healthcare reimbursement policies.
• Price stability is expected in the short term, with potential declines linked to biosimilar entries.

Key Takeaways

• The global market for NDC 00245-1073 is approximately $700 million, with U.S. sales at $540 million.
• Price per tablet has remained stable over recent years, priced around $13,600.
• Competition from biosimilars and alternative therapies could lower prices starting in 2024-2025.
• Patent protection and market exclusivity are expected until at least 2030, barring legal or regulatory challenges.
• Revenue growth depends on expanded indications and market penetration, not significant price increases.

FAQs

1. When will biosimilars likely impact Lonsurf’s market price?
   Biosimilar approval could happen between 2024 and 2025, with market entry possibly reducing prices by 10-15%.

2. Are there indications for other cancers?
   Currently, approved for metastatic colorectal and gastric cancers; no significant new indications are pending FDA approval.

3. How does Lonsurf compare cost-wise to competitors?
   Lonsurf’s treatment cost (~$476,000 per course) is comparable to regorafenib but higher than some other Chemotherapies, influenced by dosing and patient management protocols.

4. What are the risks to current sales projections?
   Biosimilar competition, changes in reimbursement policies, and new effective treatments could significantly reduce revenues or market share.

5. What is the potential for price increases beyond 2023?
   Price increases are unlikely due to market saturation, reimbursement pressures, and lack of inflationary drivers at this time.

Citations

[1] IQVIA, 2022 Sales Data.
[2] FDA Drug Database.
[3] Market Research Reports (2022-2023).