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, Nostrum Labs Inc, Oxford Pharms, Sciegen Pharms Inc, Watson Labs, and Smithkline Beecham, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for NABUMETONE

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	8
Patent Applications:	7,086
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
University of Southern Denmark	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
Invagen Pharms	NABUMETONE	nabumetone	TABLET;ORAL	078671-002	Mar 7, 2008	AB	RX	No	Yes
Invagen Pharms	NABUMETONE	nabumetone	TABLET;ORAL	078671-001	Mar 7, 2008	AB	RX	No	No
Aurobindo Pharma Usa	NABUMETONE	nabumetone	TABLET;ORAL	090516-002	Jul 12, 2010		DISCN	No	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
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-002	Dec 24, 1991
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-002	Dec 24, 1991

NABUMETONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nabumetone

Introduction to Nabumetone

Nabumetone, marketed under the brand name Relafen, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and relieve symptoms of osteoarthritis and rheumatoid arthritis. It is known for its non-acidic nature and its role as a prodrug, which reduces its gastrointestinal toxicity compared to other NSAIDs[2][5].

Market Growth Drivers

The nabumetone market is driven by several key factors:

Increasing Geriatric Population

The global population is aging, and this demographic shift is a significant driver for the nabumetone market. Elderly patients are more likely to suffer from osteoarthritis and rheumatoid arthritis, increasing the demand for effective pain management solutions like nabumetone[1][4].

Generic Pharmaceutical Production

The production of generic pharmaceuticals is on the rise, and nabumetone, being a generic drug, benefits from this trend. Generic versions of the drug are produced by various pharmaceutical companies worldwide, making it more accessible and affordable for patients[1].

Growing Pharmaceutical Startups

Developing regions are witnessing an increase in pharmaceutical startups, which are contributing to the growth of the nabumetone market. These startups often focus on producing generic and affordable medications, further boosting the market[1].

Market Segmentation

The nabumetone market is segmented based on several criteria:

Application

The market is primarily segmented into two applications:

• Osteoarthritis: Nabumetone is widely used to treat the symptoms of osteoarthritis, such as pain, inflammation, and stiffness.
• Rheumatoid Arthritis: It is also used to manage the symptoms of rheumatoid arthritis, providing relief from joint pain and inflammation[1][4].

Distribution Channel

The distribution channels for nabumetone include:

• Online Distribution: Online pharmacies and e-commerce platforms.
• Hospital and Retail Pharmacies: Traditional brick-and-mortar pharmacies and hospital pharmacies.
• Hyper and Super Markets: Large retail stores that also sell pharmaceutical products[1].

Regional Framework

The nabumetone market is analyzed across several major regions:

North America

This region is one of the largest markets for nabumetone due to a high prevalence of arthritis and a well-established healthcare system.

Europe

Europe also represents a significant market, driven by an aging population and advanced healthcare infrastructure.

Asia-Pacific (APAC)

The APAC region is expected to show substantial growth due to the rising number of pharmaceutical startups and an increasing geriatric population.

Middle East and Africa (MEA)

This region is growing steadily, driven by improving healthcare facilities and increasing awareness about arthritis treatments.

South and Central America

These regions are also witnessing growth, particularly due to the expansion of generic pharmaceutical production[1][4].

Financial Trajectory

Market Size and Forecast

The global nabumetone market is expected to grow at a significant Compound Annual Growth Rate (CAGR) from 2023 to 2031. The market size is projected to increase from US$ XX million in 2023 to US$ XX million by 2031[1][4].

Revenue Forecast

The revenue forecast for the nabumetone market is positive, driven by increasing demand and the expansion of distribution channels. The market is expected to gain substantial shares during the forecast period[4].

Key Players and Market Competition

The market is competitive, with several key players such as Glenmark Pharmaceuticals, Mylan N.V, GlaxoSmithKline plc, and ScieGen Pharmaceuticals Inc. These companies are focusing on strategic expansions, product innovations, and mergers and acquisitions to strengthen their market positions[1].

PEST Analysis

A detailed PEST (Political, Economic, Social, and Technological) analysis highlights various factors influencing the market:

Political Factors

Regulatory environments and healthcare policies in different regions play a crucial role in shaping the market. For instance, favorable regulations for generic drug production can boost market growth.

Economic Factors

Economic stability and healthcare expenditure in various countries impact the demand for nabumetone. Economic downturns can affect healthcare spending, while stable economies can lead to increased investment in healthcare.

Social Factors

The aging population and increasing awareness about arthritis treatments are significant social factors driving the market. Public health campaigns and educational programs also contribute to market growth.

Technological Factors

Advancements in pharmaceutical technology, such as improved manufacturing processes and new formulations, can enhance the efficacy and safety of nabumetone, further driving its adoption[1].

Challenges and Restraints

Despite the positive growth trajectory, the nabumetone market faces several challenges:

Side Effects and Safety Concerns

Nabumetone, like other NSAIDs, can cause gastrointestinal side effects, cardiovascular risks, and other adverse reactions. These safety concerns can limit its use in certain patient populations[2][5].

Competition from Alternative Treatments

The market faces competition from other pain management treatments, including biologics and newer NSAIDs with improved safety profiles.

Future Trends and Opportunities

The nabumetone market is expected to see several trends and opportunities in the future:

Increasing Adoption in Developing Regions

Developing regions are expected to offer significant growth opportunities due to improving healthcare infrastructure and increasing access to generic medications.

Innovations in Formulations

New formulations and delivery systems, such as sustained-release tablets or topical applications, could enhance patient compliance and reduce side effects.

Combination Therapies

The use of nabumetone in combination with other medications could offer better therapeutic outcomes and expand its market potential[1][4].

Key Takeaways

• The nabumetone market is driven by an increasing geriatric population and the growing production of generic pharmaceuticals.
• The market is segmented by application (osteoarthritis and rheumatoid arthritis) and distribution channel (online, hospital and retail pharmacies, hyper and super markets).
• The regional framework includes North America, Europe, APAC, MEA, and South and Central America.
• The market is expected to grow significantly from 2023 to 2031, driven by favorable market dynamics.
• Key players are focusing on strategic expansions and product innovations to maintain market competitiveness.
• Despite challenges, the market offers opportunities for growth through innovations in formulations and increasing adoption in developing regions.

Frequently Asked Questions (FAQs)

1. What is Nabumetone used for?

Nabumetone is used to treat mild to moderate pain and relieve symptoms of osteoarthritis and rheumatoid arthritis.

2. How does Nabumetone work?

Nabumetone works by inhibiting the enzymes COX-1 and COX-2, reducing the production of prostaglandins and thereby alleviating pain and inflammation[2].

3. What are the common side effects of Nabumetone?

Common side effects include gastrointestinal issues like acid or sour stomach, belching, and indigestion. More severe side effects can include cardiovascular risks and bleeding in the stomach or intestines[5].

4. Who are the key players in the Nabumetone market?

Key players include Glenmark Pharmaceuticals, Mylan N.V, GlaxoSmithKline plc, and ScieGen Pharmaceuticals Inc.[1].

5. What are the future trends in the Nabumetone market?

Future trends include increasing adoption in developing regions, innovations in formulations, and the potential for combination therapies to enhance therapeutic outcomes[1][4].

Cited Sources:

1. The Insight Partners. Nabumetone Market Opportunities 2031.
2. DrugBank. Nabumetone: Uses, Interactions, Mechanism of Action.
3. PubMed. Nabumetone. A preliminary review of its pharmacodynamic and pharmacokinetic properties and therapeutic use in rheumatic disease.
4. Market Research Intellect. Global Nabumetone Market Size | Share | Scope | Trend and Forecast to 2031.
5. Mayo Clinic. Nabumetone (oral route).