RELAFEN Drug Patent Profile

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

Relafen is a drug marketed by Smithkline Beecham and is included in one NDA.

The generic ingredient in RELAFEN is nabumetone. There are twenty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nabumetone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Relafen

A generic version of RELAFEN was approved as nabumetone by CHARTWELL RX on February 25^th, 2002.

Summary for RELAFEN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	3
DailyMed Link:	RELAFEN at DailyMed

See drug sales revenues for RELAFEN

Recent Clinical Trials for RELAFEN

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

Sponsor	Phase
Sanford Research	Early Phase 1
Dr. Reddy's Laboratories Limited	Phase 1

See all RELAFEN clinical trials

US Patents and Regulatory Information for RELAFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-001	Dec 24, 1991		DISCN	Yes	No
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-002	Dec 24, 1991		DISCN	Yes	No

Expired US Patents for RELAFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-001	Dec 24, 1991
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-002	Dec 24, 1991
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-001	Dec 24, 1991
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-002	Dec 24, 1991

International Patents for RELAFEN

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

Country	Patent Number	Title	Estimated Expiration
Denmark	156642
Malaysia	8100198	4-(6'-METHOXY-2'-NAPHTHYL)-BUTAN-2-ONE
Japan	S6033818
Denmark	156562
Switzerland	603543
Kenya	3082	4-(6'-METHOXY-2'-NAPHTHYL)-BUTAN-2-ONE

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: RELAFEN

Last updated: July 27, 2025

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Introduction

RELAFEN, the trade name for ketoprofen, is a non-steroidal anti-inflammatory drug (NSAID) primarily prescribed for managing pain, inflammation, and fever associated with musculoskeletal conditions, dental pain, and other inflammatory disorders. Since its approval, RELAFEN has occupied a niche but competitive segment within the global NSAID market. Understanding the evolving market dynamics and financial trajectory of RELAFEN involves analyzing regulatory landscapes, competitive forces, demographic trends, and emerging therapeutic alternatives that influence its market performance.

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Market Landscape and Therapeutic Positioning

RELAFEN's therapeutic profile aligns with traditional NSAIDs—offering effective analgesic and anti-inflammatory effects at a relatively favorable safety profile when used appropriately. The drug competes with a broad array of NSAIDs such as ibuprofen, naproxen, and diclofenac, alongside newer biologics and analgesics in specific indications.

The global NSAID market, valued at approximately USD 10.2 billion in 2022, is projected to grow at a CAGR of 4.2% through 2030, driven by rising incidence of chronic pain conditions, osteoarthritis, and rheumatoid arthritis.[1] RELAFEN maintains its relevance through its efficacy and cost-effectiveness, especially in markets where newer biologic options remain inaccessible or unaffordable.

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Market Dynamics

1. Regulatory Environment:
Regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), enforce stringent safety evaluations for NSAIDs, especially concerning gastrointestinal, cardiovascular, and renal adverse effects.[2] Recent revisions and black box warnings influence prescribing patterns, potentially impacting RELAFEN's market share. Compliance with evolving regulations becomes pivotal for maintaining market accessibility.

2. Patent Status and Generic Competition:
RELAFEN was initially protected by patent exclusivity; however, patent expirations have introduced generic competitors, notably ketoprofen generics, reducing pricing power and profit margins. The prevalence of generics in the NSAID market underscores price competition, emphasizing the importance of cost-effectiveness and formulary positioning for market sustenance.

3. Prescribing Trends and Clinical Guidelines:
Recent shifts favoring the minimal use of NSAIDs in patients with cardiovascular or gastrointestinal risk factors constrain the broad utilization of drugs like RELAFEN. Despite this, legitimate indications—acute pain, arthritis—continue to sustain demand, especially when alternatives are unsuitable or contraindicated.

4. Market Penetration in Emerging Economies:
Emerging markets represent significant growth opportunities owing to larger populations and increasing healthcare access. Lower-cost formulations of RELAFEN are appealing in markets with.price-sensitive consumers, but regulatory approval processes and local competition influence penetration.

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Financial Trajectory Overview

1. Revenue Fluctuations Post-Patent Expiry:
Initially, RELAFEN experienced peak revenues during its patent-protected phase, driven by exclusivity. Post-patent expiration, revenues declined due to the proliferation of generics, with some markets witnessing a 50-70% decrease in unit price competitively. This underscores the need for differentiation strategies, such as combination therapies or novel formulations, to mitigate revenue loss.

2. Impact of Formulation Innovations:
Developments like sustained-release formulations and combination drugs may rejuvenate RELAFEN's financial prospects by enabling premium pricing and enhanced patient compliance. Such innovations can also support positioning in niches with unmet needs.

3. Market Share Trends:
In mature markets like the U.S. and Europe, RELAFEN's market share has declined gradually, primarily replaced by OTC NSAIDs and newer prescription options with better safety profiles.[3] Conversely, in regions with less stringent regulations or limited access to newer agents, RELAFEN remains a significant revenue contributor.

4. Strategic Partnerships and Licensing:
Pharmaceutical companies have adopted licensing strategies to extend product life cycles, including co-promotion agreements and regional licensing, which help sustain revenue streams despite generic competition. These partnerships also foster entry into new markets, especially in Asia and Latin America.

5. Pricing Strategies and Reimbursement:
Reimbursement policies heavily influence product financial trajectory. Favorable formulary positioning enhances sales, while restrictive policies or negative formulary decisions curtail revenue. Price erosion due to increased generic competition compels manufacturers to adopt value-based pricing models.

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Future Outlook

The outlook for RELAFEN hinges on multiple factors:

• Safety Profile Enhancements: Developing formulations with improved safety margins could expand indications, such as long-term management of chronic inflammatory conditions.
• Combination Therapies: Incorporating RELAFEN into multi-ingredient formulations could differentiate offerings and justify premium pricing.
• Regulatory Approvals for New Indications: Expanding approved uses, especially in pediatric or specialized pain management, could unlock additional revenue streams.
• Digital and Patient-Centric Approaches: Leveraging digital health tools for adherence and monitoring enhances patient outcomes, fostering long-term market viability.

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Key Market Challenges

• Evolving Safety Concerns: The cardiovascular and gastrointestinal risks associated with NSAIDs, including RELAFEN, restrict prescribing in susceptible populations.
• Generic Market Pressures: The commoditization of ketoprofen reduces margins, necessitating cost-efficient manufacturing and aggressive marketing.
• Competition from Non-NSAID Analgesics: Advances in biologics and opioids for inflammatory and pain conditions threaten NSAID market share.
• Regulatory Stringency: Increased scrutiny could lead to label restrictions, affecting marketing and sales.

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Strategic Recommendations

• Invest in Formulation Innovation: Sustained-release or combination formulations mitigate competition and command premium pricing.
• Target Niche Markets: Focus on indications and patient groups where NSAID safety profiles are acceptable, and unmet needs persist.
• Enhance Market Access: Engage with payers and policymakers to secure favorable reimbursement pathways.
• Expand Geographic Reach: Focus on emerging markets with high growth potential and lower competitive saturation.

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Key Takeaways

• The NSAID market, including RELAFEN, faces commoditization driven by patent expiries and intense generic competition.
• Safety profile considerations are critical in maintaining and expanding RELAFEN’s market share, emphasizing the need for safer formulations.
• Demographic trends, notably aging populations and rising chronic pain prevalence, offer long-term growth opportunities.
• Strategic innovation, geographic expansion, and stakeholder engagement are vital to offset revenue declines and ensure sustainable financial performance.
• Regulatory landscapes significantly influence market access and pricing strategies, making continuous compliance essential.

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FAQs

1. How has patent expiration affected RELAFEN’s market share?
Patent expiration introduced generic competitors, leading to substantial price declines and reduced market share, typical of NSAID markets post-patent expiry.

2. Are there safety concerns inhibiting RELAFEN use?
Yes. Like other NSAIDs, RELAFEN carries risks of gastrointestinal and cardiovascular adverse events, which may restrict use in high-risk populations.

3. Can formulation innovations improve RELAFEN’s market position?
Sustained-release and combination formulations can differentiate RELAFEN, potentially improving adherence, safety, and pricing power.

4. What are the opportunities for growth in emerging markets?
Lower-cost formulations and regulatory approvals in emerging regions facilitate market penetration, addressing unmet needs and expanding revenue streams.

5. How does regulatory scrutiny impact RELAFEN’s future?
Enhanced safety regulations and labeling restrictions can limit prescribing scope, but proactive compliance and demonstration of safety can mitigate negative impacts.

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Sources

[1] MarketsandMarkets, "NSAID Market by Type," 2022.
[2] FDA, "NSAID Safety Communications," 2021.
[3] IQVIA, "Pharmaceutical Sales Data," 2022.