FELDENE Drug Patent Profile

When do Feldene patents expire, and when can generic versions of Feldene launch?

Feldene is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in FELDENE is piroxicam. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the piroxicam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Feldene

A generic version of FELDENE was approved as piroxicam by TEVA on December 11^th, 1992.

Summary for FELDENE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	160
Clinical Trials:	2
Drug Prices:	Drug price information for FELDENE
What excipients (inactive ingredients) are in FELDENE?	FELDENE excipients list
DailyMed Link:	FELDENE at DailyMed

See drug prices for FELDENE

Recent Clinical Trials for FELDENE

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

Sponsor	Phase
Cairo University	Early Phase 1
Pamukkale University	Phase 4

See all FELDENE clinical trials

US Patents and Regulatory Information for FELDENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982	AB	RX	Yes	No
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982	AB	RX	Yes	Yes

Expired US Patents for FELDENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-002	Apr 6, 1982
Pfizer	FELDENE	piroxicam	CAPSULE;ORAL	018147-003	Apr 6, 1982

International Patents for FELDENE

See the table below for patents covering FELDENE around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	140014
United Kingdom	1544358
Germany	1570246
Portugal	66639	PROCESS FOR THE PREPARATION OF 3,4-DIHYDRO-2-METHYL-4-OXO-2H-1,2-BENZOTHIAZINE-3-CARBOXYLIC ACID-1,1-DIOXIDE
Germany	1967325

Market Dynamics and Financial Trajectory for FELDENE (Diflunisal)

Last updated: July 31, 2025

Introduction

Feldene, with the generic name Diflunisal, is a non-steroidal anti-inflammatory drug (NSAID) primarily used to treat pain, fever, and inflammation. Since its initial development by Roche in the 1960s, Feldene has maintained a niche market, primarily in pain management and inflammatory conditions. Understanding the market dynamics and financial trajectory of Feldene involves analyzing its current positioning, patent landscape, competitive environment, regulatory considerations, and market trends within the global NSAID segment.

Market Position and Therapeutic Profile

Feldene is distinguished by its selective action, offering anti-inflammatory benefits with a comparatively favorable gastrointestinal safety profile among NSAIDs. Its primary indications include osteoarthritis, rheumatoid arthritis, and miscellaneous musculoskeletal pains. Compared to newer NSAID formulations and COX-2 inhibitors, Feldene’s established efficacy, longstanding clinical use, and safety profile position it as a reliable therapeutic option.

However, its market share has declined due to increased competition from cyclooxygenase-2 (COX-2) inhibitors like celecoxib, which offer reduced gastrointestinal adverse effects. Nonetheless, Feldene continues to serve as a cost-effective and effective alternative, especially in regions with limited access to newer drugs.

Market Dynamics

1. Competitive Landscape

The global NSAID market is highly competitive, driven by patent expirations and the advent of novel therapies. The development of COX-2 selective inhibitors challenged traditional NSAIDs, including Feldene, by offering a lower risk of gastrointestinal side effects. Despite patent expirations, Feldene remains generic, which constrains its pricing power but sustains its accessibility depending on regional healthcare systems.

Key competitors include OTC options like ibuprofen and naproxen, as well as prescription NSAIDs like diclofenac and celecoxib. The rise of biologic agents for inflammatory conditions (e.g., rheumatoid arthritis) further impacts Feldene’s relevance in some indications.

2. Regulatory and Patent Considerations

Feldene’s patent has long expired, leading to its widespread availability as a generic. This significantly impacts its market exclusivity and limits revenue growth potential. Regulatory scrutiny around NSAID safety, especially concerning cardiovascular risk and gastrointestinal toxicity, influences prescribing patterns.

In some markets, regulatory authorities have issued warnings regarding NSAID misuse and adverse effects, prompting cautious use. Conversely, regional variations in regulation, patent protections, and healthcare policies can influence product availability and acceptance.

3. Market Trends and Consumer Preferences

There is a growing shift towards personalized medicine and safer pain management options. Consumer preferences lean toward OTC NSAIDs for minor ailments, reducing the demand for prescription-only drugs like Feldene. Nonetheless, its role in managing chronic inflammatory conditions sustains demand in certain demographic segments.

The increasing prevalence of osteoarthritis and rheumatoid arthritis globally, driven by aging populations, supports continued pharmaceutical interest in NSAID therapy, including generics like Feldene.

4. Pricing and Reimbursement Policies

In markets with robust healthcare reimbursement schemes, generic NSAIDs like Feldene benefit from broader accessibility. Price competition from other generic NSAIDs suppresses revenues but sustains volume sales. Price fluctuations, insurance coverage, and formulary decisions directly influence financial performance.

Financial Trajectory Analysis

1. Revenue Streams

As a generic drug, Feldene’s revenue primarily hinges on volume sales rather than high margins. The product’s mature status limits significant revenue growth, particularly after patent expiry and macro-trends favoring newer therapies.

2. Profitability Outlook

Cost-effective manufacturing and widespread availability underpin consistent profitability in mature markets. However, the decline in prescription volumes due to safety concerns and market competition weakens revenue streams.

3. Geographic Revenue Distribution

North America and Europe represent significant markets for Feldene, leveraging established healthcare infrastructure. Emerging markets in Asia and Latin America display growing demand owing to the high prevalence of musculoskeletal disorders and limited access to innovative therapies.

4. Impact of Market Forces

Global patent expirations, changing regulatory landscapes, and shifting consumer preferences contribute to a modest, gradually declining financial trajectory. Nevertheless, stable demand in certain segments ensures continuity of revenue.

5. Future Growth Opportunities

Potential growth avenues could include repositioning Feldene within combination therapies, exploring new indications, or developing extended-release formulations. However, such strategies face significant barriers given the availability of newer, patented drugs.

Regulatory and Market Challenges

• Safety Concerns: Cardiovascular risks associated with NSAIDs impact prescriptions and reimbursement policies.
• Competition: Dominance of newer NSAID and biologic options reduces Feldene’s market share.
• Generic Competition: Price erosion from multiple generic manufacturers limits profitability.
• Market Saturation: Mature markets exhibit limited growth potential without significant innovation or repositioning.

Emerging Trends and Industry Shifts

The trajectory of Feldene is increasingly influenced by a shift toward personalized, safer, and more targeted anti-inflammatory therapies. Biologics and disease-modifying agents are capturing growing segments of rheumatoid arthritis and osteoarthritis treatment, indirectly constraining Feldene’s growth.

Additionally, the increasing emphasis on prescription vs. OTC NSAID use impacts sales volumes, with greater caution around long-term NSAID therapy influencing prescribing behavior.

Conclusion

Feldene’s market dynamics are shaped by a mature product landscape characterized by intense competition, patent expirations, safety concerns, and evolving therapeutic preferences. Its financial trajectory reflects a stable but declining pattern driven predominantly by volume sales of generic formulations. Future prospects hinge on strategic repositioning, addressing safety profiles, and tapping into emerging markets with high disease prevalence.

Pharmaceutical companies operating in this space should consider diversification and innovation strategies to maintain relevance amid accelerating growth in biologics and personalized medicine.

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Key Takeaways

• Feldene remains an important, cost-effective NSAID but faces declining market share due to safety concerns and market competition.
• Patent expiry and increased competition from generics and newer therapies curtail profitability and growth potential.
• Regional variations in regulation and healthcare policies influence its demand and reimbursement landscape.
• Demographic shifts toward older populations and rising prevalence of inflammatory diseases sustain some demand, primarily in emerging markets.
• Innovation or strategic repositioning could enable incremental growth, but the trajectory remains primarily stable with gradual decline.

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FAQs

1. What factors have contributed to the decline of Feldene's market share?
Patent expiration, safety concerns (cardiovascular and gastrointestinal risks), the rise of COX-2 inhibitors, and increased competition from generics and newer therapies have driven its decline.

2. How does Feldene compare to other NSAIDs in terms of safety?
Feldene generally exhibits a favorable gastrointestinal safety profile among NSAIDs but still carries cardiovascular risks typical of the class, limiting its prescribing in high-risk patients.

3. Are there any promising new indications for Feldene?
Currently, Feldene’s main indications are limited to pain and inflammation management; no significant new indications are widely recognized or under active development.

4. What regions present the most growth opportunities for Feldene?
Emerging markets such as Asia and Latin America, driven by high osteoarthritis and rheumatoid arthritis prevalence, offer growth potential amid lower regulatory barriers.

5. How might future regulatory changes impact Feldene’s market?
Enhanced safety regulations and warnings could restrict prescribing, while reimbursement policies might favor newer, safer alternatives, further challenging Feldene’s market position.

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Sources:

1. [1] European Medicines Agency (EMA). "Diflunisal Summary."
2. [2] IQVIA. "Global Analgesics Market Report," 2022.
3. [3] FDA. “NSAID Risk Warnings.”
4. [4] GlobalData. “NSAID Market Trends 2023.”
5. [5] Pfizer. “Generics Portfolio and Market Strategy.”