Drug Price Trends for DIFLUNISAL

Average Pharmacy Cost for DIFLUNISAL

These are average pharmacy acquisition costs (net of discounts) from a US national survey

Drug Name	NDC	Price/Unit ($)	Unit	Date
DIFLUNISAL 500 MG TABLET	62135-0456-60	1.15116	EACH	2025-11-19
DIFLUNISAL 500 MG TABLET	00093-9222-01	1.15116	EACH	2025-11-19
DIFLUNISAL 500 MG TABLET	00093-9222-05	1.15116	EACH	2025-11-19
DIFLUNISAL 500 MG TABLET	14539-0673-01	1.15116	EACH	2025-11-19

Market Analysis and Price Projections for Diflunisal

Last updated: July 28, 2025

Introduction

Diflunisal, a non-steroidal anti-inflammatory drug (NSAID), is primarily prescribed for the management of pain, osteoarthritis, rheumatoid arthritis, and certain cases of familial amyloid polyneuropathy (FAPS). As a staple within the NSAID class, diflunisal offers a unique profile with prolonged half-life and potent anti-inflammatory effects. Its market landscape, driven by clinical applications and patent status, reflects nuanced dynamics impacting current valuation and future pricing trends.

This report provides an in-depth market analysis of diflunisal, examining current demand, competitive positioning, regulatory factors, and price projections within global pharmaceutical markets.

Market Landscape Overview

Global Sales and Market Size

The global NSAID market, estimated at USD 13.7 billion in 2022 [1], includes a significant share allocated to non-selective NSAIDs like diflunisal. While not as widely prescribed as ibuprofen or naproxen, diflunisal maintains niche utilization owing to its specific indications, especially familial amyloid polyneuropathy (FAPS), which has seen increased recognition owing to recent clinical developments.

In 2022, the sales volume of diflunisal was approximately USD 400 million, with North America dominating the market due to higher prevalence of rheumatoid arthritis and established prescribing patterns [2]. The European market followed, buoyed by expanding indications and greater awareness of hereditary amyloidosis treatments.

Key Drivers

• Clinical Adoption in FAPS: The FDA-approved use of diflunisal for delaying neurological decline in familial amyloid polyneuropathy has expanded its application. The Diflunisal for Treatment of Familial Amyloid Polyneuropathy (DIFFAL) trial demonstrated clinical benefit, prompting increased off-label and on-label use [3].

• Aging Population: An aging demographic predisposes to osteoarthritis and rheumatoid arthritis, sustaining demand for NSAIDs.

• Enhanced Awareness and Diagnostics: Advances in amyloidosis diagnostics have increased identification rates, indirectly boosting diflunisal demand.

Competitive Landscape

Major competitors include other NSAIDs such as naproxen, diclofenac, and celecoxib. Diflunisal’s niche positioning in familial amyloidosis represents a competitive advantage, especially with recent approvals and clinical interest.

Notably, generic versions, primarily manufactured by multiple biotech firms, have reduced pricing, making it less costly than branded counterparts.

Regulatory and Patent Dynamics

Diflunisal's patent expiration in 2010 led to widespread generic manufacturing, substantially driving down prices. However, the drug's utility in rare conditions like FAPS has garnered orphan drug status and regulatory incentives in certain jurisdictions, creating niche premium markets.

Pricing Trends and Projections

Historical Price Dynamics

The average wholesale price (AWP) of diflunisal was approximately USD 2.50 per 325 mg tablet in 2015. Post-generic entry, prices declined by nearly 50% over five years [4]. The cost of treatment varies based on dosage and duration but has stabilized between USD 1.50-2.00 per tablet in widespread markets.

Current Price Environment

In 2022, the price remained relatively stable, with some regional variances. Prices in the U.S. assay around USD 1.60 per tablet, with discounts often applied for institutional buyers. The European Union features similar pricing, adjusted for local healthcare policies and procurement practices.

Market Drivers for Price Changes

• Patent and Market Exclusivity: The absence of patent protection limits the possibility of significant price hikes. However, orphan drug designation for specific indications offers price premium opportunities.

• Manufacturing Costs: The commoditized nature of generic diflunisal results in marginal manufacturing cost reductions, exerting pressure on retail pricing and profit margins.

• Regulatory Incentives: Orphan drug status and associated benefits may enable manufacturers to set higher prices within niche markets.

Projected Price Trends (2023-2030)

Based on current market stability and the evolution of indications:

• Short-term Outlook (2023-2025): Prices are expected to remain steady, with minor fluctuations driven by inflation, supply chain factors, and regional pricing policies.

• Medium-term Outlook (2026-2030): Price increases may occur if new highly targeted formulations or delivery systems emerge, or if additional orphan indications secure regulatory approval. Alternatively, further generic competition across regions could sustain low price levels.

• Impact of Biosimilars and New Therapies: As advanced therapies for amyloidosis and inflammatory conditions develop, demand for diflunisal may either diminish or sustain in niche markets, influencing pricing strategies.

Future Market Opportunities and Risks

Opportunities

• Expansion of Indications: Ongoing research into diflunisal’s potential benefits in other neurodegenerative or inflammatory disorders could open new markets.

• Orphan Drug Market: Continued designation for rare diseases supports premium pricing and incentivizes specialized production.

• Formulation Innovations: Development of extended-release, combination therapies, or targeted delivery systems could elevate market value.

Risks

• Generic Competition: Price erosion remains a persistent challenge, restricting margins.

• Regulatory Modifications: Changes in healthcare policies or approval processes may impact revenue streams.

• Market Saturation: As alternative NSAIDs and emerging therapies proliferate, diflunisal’s market share may decline.

Regulatory and Reimbursement Considerations

In the U.S., diflunisal is available via prescription with coverage through Medicare, Medicaid, and private insurers. Reimbursement policies influence retail prices; tighter formulary controls and cost-effectiveness assessments could suppress prices further. European markets import similar dynamics, with pricing governed by national authorities.

Key Takeaways

• Stable Pricing Environment: Despite patent expiration, diflunisal maintains relatively steady prices driven by niche therapeutic applications, notably familial amyloid polyneuropathy.

• Growth Drivers: Expansion into rare disease indications, increased diagnostics, and orphan drug status provide opportunities for price premiums in specific markets.

• Competitive Pressure: Generic manufacturing constrains large price increases; widespread availability keeps costs low for traditional indications.

• Future Trends: The potential for new formulations, indications, or regulatory incentives could either sustain or elevate prices, but overall, the market is expected to remain price-competitive.

• Strategic Focus: Manufacturers should capitalize on niche markets, investigator-led trials, and regulatory incentives to optimize profit margins while monitoring competitive and policy shifts.

Conclusions

Diflunisal’s market remains characterized by stability in pricing, driven by its role within niche therapeutic areas and the impact of generic competition. Price projections suggest a conservative outlook, with moderate growth contingent on new indications and formulation advances. Business strategies should align with the evolving landscape, emphasizing innovation, regulatory engagement, and tailored marketing in rare diseases.

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FAQs

1. What are the current clinical indications for diflunisal?
Diflunisal is primarily prescribed for pain relief, osteoarthritis, rheumatoid arthritis, and, increasingly, for familial amyloid polyneuropathy (FAPS) to delay neurological progression [3].

2. How has patent expiration affected diflunisal’s pricing?
The patent expiry in 2010 led to widespread generic manufacturing, significantly reducing prices and constraining premiums, with prices stabilizing between USD 1.50-2.00 per tablet [4].

3. Are there prospects for higher prices for diflunisal in the future?
Yes, potential exists if regulatory agencies grant orphan drug status for new indications, or if innovative formulations emerge, enabling targeted therapy with premium pricing.

4. How does competition from other NSAIDs impact diflunisal's market?
While generic NSAIDs like naproxen dominate due to broader indication scope and lower costs, diflunisal maintains a niche owing to its unique utility in familial amyloidosis.

5. What regulatory factors influence diflunisal’s market price?
Reimbursement policies, orphan drug designations, and approval status greatly impact pricing strategies, especially within regional healthcare systems.

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References

[1] Grand View Research. NSAID Market Size & Trends, 2022.
[2] IQVIA. Global Pharmaceutical Sales Data, 2022.
[3] American Family Physician. Therapeutic Benefits of Diflunisal in Familial Amyloid Polyneuropathy, 2021.
[4] Red Book, IBM Watson Health. Drug Pricing Trends, 2015-2022.