NABUMETONE - Generic Drug Details

What are the generic sources for nabumetone and what is the scope of patent protection?

Nabumetone is the generic ingredient in two branded drugs marketed by Annora Pharma, Aurobindo Pharma Usa, Chartwell Molecules, Chartwell Rx, Copley Pharm, Epic Pharma Llc, Impax Labs Inc, Invagen Pharms, Lgm Pharma, Mpp Pharma, Novitium Pharma, Oxford Pharms, Sciegen Pharms Inc, Watson Labs, and Smithkline Beecham, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for nabumetone. Twenty-six suppliers are listed for this compound.

Summary for NABUMETONE

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	15
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	8
Patent Applications:	7,504
Drug Prices:	Drug price trends for NABUMETONE
Drug Sales Revenues:	Drug sales revenues for NABUMETONE
What excipients (inactive ingredients) are in NABUMETONE?	NABUMETONE excipients list
DailyMed Link:	NABUMETONE at DailyMed

See drug prices for NABUMETONE

See drug sales revenues for NABUMETONE

Recent Clinical Trials for NABUMETONE

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

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
The Danish Rheumatism Association	N/A

See all NABUMETONE clinical trials

Pharmacology for NABUMETONE

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NABUMETONE

M01AX	Other antiinflammatory and antirheumatic agents, non-steroids
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

US Patents and Regulatory Information for NABUMETONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lgm Pharma	NABUMETONE	nabumetone	TABLET;ORAL	203166-002	Aug 30, 2019	AB	RX	No	No
Mpp Pharma	NABUMETONE	nabumetone	TABLET;ORAL	090427-002	Dec 30, 2011		DISCN	No	No
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-002	Dec 24, 1991		DISCN	Yes	No

Expired US Patents for NABUMETONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-001	Dec 24, 1991	4,061,779
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-002	Dec 24, 1991	4,420,639*PED
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-002	Dec 24, 1991	4,061,779

Market Dynamics and Financial Trajectory for NABUMETONE

Last updated: July 27, 2025

Introduction

Nabumetone, a non-steroidal anti-inflammatory drug (NSAID), is primarily used to treat conditions such as rheumatoid arthritis and osteoarthritis. As a product of Johnson & Johnson's subsidiary, Janssen Pharmaceuticals, nabumetone has carved a niche within the NSAID market. Its unique pharmacological profile and market positioning influence its market trajectory and financial prospects amid evolving healthcare dynamics.

Pharmacological Profile and Market Positioning

Nabumetone distinguishes itself from traditional NSAIDs through its selective COX-2 enzyme inhibition, aiming to reduce gastrointestinal side effects associated with NSAID use. This attribute positions nabumetone favorably among patients with heightened gastrointestinal risk, a significant market segment given the widespread prevalence of arthritis and related conditions.

Despite its advantages, nabumetone's market share remains modest compared to competitors like ibuprofen, naproxen, and celecoxib. Factors influencing its positioning include established prescribing habits, brand loyalty, and the availability of newer therapeutic agents such as biologics.

Market Dynamics

1. Prevalence of Arthritis and Chronic Pain

The rising global prevalence of osteoarthritis and rheumatoid arthritis drives demand for NSAIDs. According to the Global Burden of Disease Study, musculoskeletal disorders are among the leading causes of disability worldwide [1]. This epidemiological trend sustains the baseline demand for drugs like nabumetone.

2. Shift Toward Safer NSAIDs

Safety profiles significantly influence prescribing behaviors. Nabumetone's lower gastrointestinal toxicity offers competitive advantage over traditional NSAIDs in populations at risk for GI adverse events. However, the emergence of selective COX-2 inhibitors (e.g., celecoxib) has challenged nabumetone's market share due to their targeted safety profile.

3. Regulatory Environment

Regulatory scrutiny pertaining to NSAID-associated cardiovascular risks, notably posterior issues linked to some COX-2 inhibitors, influences market dynamics. Companies must navigate stringent safety assessments, impacting product positioning and marketing strategies [2].

4. Competitive Landscape

Generic availability and patent expiration timelines impact revenue potential. While nabumetone's patent has long expired, its popularity is restrained by the dominance of other NSAIDs and biologics. Market penetration hinges on differentiating safety and efficacy profiles and price competitiveness.

5. Healthcare Cost and Reimbursement Policies

Reimbursement frameworks and healthcare expenditures directly affect sales. Cost-effective NSAID options like nabumetone find favor in cost-sensitive markets, especially in developing regions where patented biologics remain inaccessible.

6. Emerging Therapeutics

The advent of biologic disease-modifying antirheumatic drugs (DMARDs) and targeted synthetic DMARDs offers alternatives for severe rheumatoid arthritis, potentially reducing NSAID reliance. This therapeutic evolution constrains nabumetone’s long-term market growth, primarily limited to mild to moderate cases.

Financial Trajectory

1. Historical Performance

As a relatively minor player within Johnson & Johnson’s portfolio, nabumetone historically generated modest revenue, primarily driven by steady prescriptions for arthritis management. Its sales are characterized by stability rather than growth, constrained by market saturation and intense competition.

2. Current Market Trends

The shift toward personalized medicine and targeted therapies constrains NSAID growth. While nabumetone benefits from its safety profile, overall demand growth is tempered. Johnson & Johnson's strategic focus on innovative and biologic therapies further limits investment in nabumetone-specific R&D, potentially leading to revenue plateau or decline.

3. Forecasted Growth

Forecasts project limited growth prospects for nabumetone, with incremental sales driven by aging populations and continued use in less severe cases. However, the expanding availability of safer and more effective alternatives—particularly in developed markets—may inversely impact sales volumes.

4. Emerging Markets

In regions with limited access to biologics, nabumetone could experience modest growth due to its favorable safety profile and affordability. Strategic marketing and physician education could unlock additional demand streams.

5. Impact of Patent and Patent-Like Exclusivities

Since patent expiration, generic competitors have entered the market, exerting downward pressure on prices and margins. Consequently, revenue trajectories are expected to remain muted unless niche utility or formulations are developed.

Strategic Implications

For stakeholders, understanding nabumetone’s market and financial trajectory reveals several strategic insights:

• Product Differentiation: Emphasizing nabumetone’s safety profile in markets with high GI complication risk sustains its niche status.
• Market Expansion: Focusing on emerging markets where NSAIDs remain first-line treatments could bolster sales.
• Formulation Innovation: Developing novel formulations or combination therapies could create new revenue streams.
• Positioning Amid Competition: Highlighting distinct pharmacokinetic properties and safety benefits could reinforce its market niche against newer competitors.

Conclusion

Nabumetone's market dynamics are characterized by a mature, commoditized environment facing increasing competition from both traditional NSAIDs and novel biologics. Its financial trajectory appears stable but limited, with growth potential primarily in underserved markets or niche applications. Strategic positioning emphasizing safety and cost-effectiveness remains vital for maintaining relevance.

---

Key Takeaways

• Nabumetone benefits from a safety profile that appeals to specific patient segments, notably those at risk for gastrointestinal complications.
• The global rise in arthritis prevalence sustains baseline demand, but competition from newer therapeutics constrains growth.
• Patent expirations and generic competition have suppressed pricing and profit margins, impacting revenue potential.
• Expansion into emerging markets offers modest growth opportunities due to affordability and limited access to biologics.
• Innovation and targeted market strategies are essential for extending the product’s financial viability amidst evolving healthcare landscapes.

---

FAQs

1. What distinguishes nabumetone from other NSAIDs?
Nabumetone is a selectively formulated NSAID with reduced gastrointestinal toxicity, making it preferable for patients with GI risk factors—a significant differentiator among NSAIDs.

2. How does the patent lifecycle affect nabumetone’s financial outlook?
Since patent expiration, generic competition has driven prices down, limiting revenue growth and emphasizing the importance of niche positioning and market expansion.

3. What are the main competitive threats to nabumetone?
Traditional NSAIDs, selective COX-2 inhibitors with improved safety profiles, and biologic therapies for severe arthritis pose significant competition, reducing nabumetone’s market share.

4. Can nabumetone expand its market presence?
Yes, particularly in emerging markets and among patients contraindicated for biologics. Strategic marketing emphasizing its safety and affordability can facilitate growth.

5. What future developments could impact nabumetone’s market?
The advent of personalized medicine, new anti-inflammatory agents, and safer biologic therapies could further diminish NSAID relevance, necessitating continued innovation and strategic repositioning.

---

Sources:

[1] GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. "Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries, 1990–2017." The Lancet, 2018.
[2] Silverstein, F.E., et al. "Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs." New England Journal of Medicine, 1999.