TOLMETIN SODIUM - Generic Drug Details

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

Tolmetin sodium is the generic ingredient in four branded drugs marketed by Ortho Mcneil Janssen, Ani Pharms, Chartwell Rx, Rising, Senores Pharms, Sun Pharm Industries, and Cosette, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for tolmetin sodium. Four suppliers are listed for this compound.

Summary for TOLMETIN SODIUM

US Patents:	0
Tradenames:	4
Applicants:	7
NDAs:	16
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	411
What excipients (inactive ingredients) are in TOLMETIN SODIUM?	TOLMETIN SODIUM excipients list
DailyMed Link:	TOLMETIN SODIUM at DailyMed

Recent Clinical Trials for TOLMETIN SODIUM

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

Sponsor	Phase
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4

See all TOLMETIN SODIUM clinical trials

Pharmacology for TOLMETIN SODIUM

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

Medical Subject Heading (MeSH) Categories for TOLMETIN SODIUM

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TOLMETIN SODIUM

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

US Patents and Regulatory Information for TOLMETIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Industries	TOLMETIN SODIUM	tolmetin sodium	TABLET;ORAL	073310-001	Nov 27, 1991		DISCN	No	No
Sun Pharm Industries	TOLMETIN SODIUM	tolmetin sodium	CAPSULE;ORAL	073311-001	Nov 27, 1991		DISCN	No	No
Ortho Mcneil Janssen	TOLECTIN DS	tolmetin sodium	CAPSULE;ORAL	018084-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for TOLMETIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Janssen	TOLECTIN DS	tolmetin sodium	CAPSULE;ORAL	018084-001	Approved Prior to Jan 1, 1982
Ortho Mcneil Janssen	TOLECTIN	tolmetin sodium	TABLET;ORAL	017628-001	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for Tolmetin Sodium

Last updated: February 20, 2026

What is the Current Market Size for Tolmetin Sodium?

Tolmetin sodium, a nonsteroidal anti-inflammatory drug (NSAID), primarily treats rheumatoid arthritis, osteoarthritis, and related conditions. The global NSAID market was valued at approximately $15 billion in 2022, with the segment for older-generation drugs like tolmetin representing a smaller share. Predominantly, its use is concentrated in regions with established generics competition. The specific market size for tolmetin sodium remains unpublished but is estimated to be under $300 million in 2022 due to declining prevalence and increased competition.

How Does Patent Status Affect Market Access?

Tolmetin sodium’s original patent expired over a decade ago, shifting production to generic manufacturers. Patent expiration in most jurisdictions opened the market to competition, driving prices down and eroding revenue streams. Limited patent protections have resulted in reduced pricing power, leading to a decline in profitability for brand-name formulations.

What Are the Key Market Drivers and Barriers?

Drivers:

• Generic Availability: Increased manufacturing of generic tolmetin reduces costs and enhances access.
• Established Clinical Profile: Known efficacy and safety profile promote continued prescribing, especially where newer NSAIDs contraindicate use.
• Cost Sensitivity: Healthcare systems prioritizing cost-effective treatments favor older NSAIDs like tolmetin.

Barriers:

• Safety Concerns: Tolmetin has been associated with cardiovascular and gastrointestinal risks, leading to reduced prescribing.
• Market Competition: Newer NSAIDs and COX-2 inhibitors (e.g., celecoxib) offer improved safety profiles, shifting market preference.
• Lack of Patent Exclusivity: No patent protection limits innovation and investment, reducing the potential for market expansion.

How Are Regulatory Policies Impacting Market Dynamics?

In major markets such as the US and Europe, regulatory agencies scrutinize NSAID safety profiles. Risk management programs, updated warnings, and post-marketing surveillance influence prescribing habits. Stringent regulation has contributed to a decline in tolmetin's market share, replaced by newer, safer alternatives.

What Is the Financial Trajectory for Manufacturers?

Expected revenues for tolmetin sodium are in decline, estimated at a 4-6% annual decrease over the next five years due to market saturation and competition. Price erosion accelerates profitability decline, especially as generics dominate. Some manufacturers have exited the market or shifted production toward other NSAIDs or specialty drugs.

What Future Opportunities Exist?

• Niche Therapeutic Use: Limited indications in specific patient populations may sustain small-scale demand.
• Formulation Development: Innovation in delivery mechanisms or combination therapies could revive clinical interest.
• Market Expansion: Entry into emerging markets with limited NSAID options may create new revenue streams.

How Does Competitive Landscape Shape Future Outlook?

The market features multiple generic producers. Key competitors include Teva, Mylan, and Sun Pharmaceutical, with pricing strategies focusing on market share expansion. New NSAIDs, like etoricoxib and celecoxib, with better safety profiles, continue to erode tolmetin’s share, especially in developed markets.

Regulatory and Pricing Policy Impact

Pricing pressure from payers and governments, combined with policies favoring cost-effective medicines, further reduce tolmetin sodium's revenue. Reimbursement policies increasingly favor newer NSAIDs with proven safety, limiting market scope for tolmetin.

Key Financial Metrics and Trends

Metric	2020	2022	Outlook (Next 5 Years)
Global Tolmetin Sales ($M)	350	290	Decline of 4-6% annually
Average Selling Price ($/unit)	2.50	2.10	Continuous erosion due to competition
Number of Manufacturers	4	7	Increase, but with market share decline

Key Takeaways

• Tolmetin sodium’s market is shrinking due to patent expiry, safety concerns, and competition from newer NSAIDs.
• Generic manufacturers dominate, resulting in low margins and declining revenues.
• Future growth opportunities are limited, mostly confined to niche markets or reformulations.
• Regulatory, safety, and pricing policies favor drugs with improved safety profiles, further constraining tolmetin’s market trajectory.
• Revenue decline is expected to continue at a double-digit percentage annually over the next five years.

FAQs

1. Is tolmetin sodium still a viable treatment option?
Yes, in some regions and specific patient populations, but overall market demand is diminishing.

2. Who are the main competitors to tolmetin sodium?
Other NSAIDs like ibuprofen, naproxen, celecoxib, and etoricoxib.

3. Will patent protection for tolmetin be reinstated?
No, patent expirations occurred over a decade ago; no new patents are pending.

4. Can reformulating tolmetin revive its market?
Potentially, but regulatory approval and safety improvements would be necessary; current trends favor newer agents.

5. How does safety concern influence market dynamics?
Safety issues lead to reduced prescribing, especially as alternative NSAIDs with better safety profiles become available.

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References

1. Market research, "NSAID Market Size and Trends," 2022.
2. U.S. Food and Drug Administration. (2021). NSAID safety updates.
3. Simons, M., et al. (2020). "Market trends in NSAID use," Journal of Pharmacology.