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, Anda Repository, Ani Pharms, Chartwell Rx, Rising, 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. Three 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:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	430
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
Chartwell Rx	TOLMETIN SODIUM	tolmetin sodium	CAPSULE;ORAL	073462-001	Apr 30, 1992		DISCN	No	No
Anda Repository	TOLMETIN SODIUM	tolmetin sodium	CAPSULE;ORAL	073290-001	Nov 27, 1991		DISCN	No	No
Ortho Mcneil Janssen	TOLECTIN	tolmetin sodium	TABLET;ORAL	017628-001	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: An In-Depth Analysis

Last updated: July 28, 2025

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Introduction

Tolmetin sodium, a non-steroidal anti-inflammatory drug (NSAID), has historically addressed mild to moderate pain, arthritis, and inflammatory conditions. Despite its clinical utility, its market positioning has faced shifting dynamics shaped by regulatory changes, competitive landscape, and evolving therapeutic paradigms. This analysis explores the current market forces influencing tolmetin sodium, its financial prospects, and future trajectory within the pharmaceutical industry.

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Pharmaceutical Profile of Tolmetin Sodium

Tolmetin sodium belongs to the NSAID class, exerting its anti-inflammatory effects primarily through cyclooxygenase (COX) enzyme inhibition. Originally marketed in the 1970s, it was positioned as an alternative to drugs like aspirin and other NSAIDs, with a focus on pain relief and inflammation mitigation. While effective, tolmetin's safety profile, particularly gastrointestinal (GI) side effects, parallels that of its NSAID counterparts, contributing to its declining prominence in favor of newer agents with improved safety profiles.

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Market Dynamics

Regulatory Environment and Safety Concerns

The late 20th and early 21st centuries saw increased scrutiny of NSAIDs concerning adverse effects, especially GI bleeding, cardiovascular risks, and renal toxicity [1]. Regulatory agencies, notably the FDA, issued black box warnings and updated prescribing guidelines, prompting clinicians to shift towards drugs with better safety profiles, like celecoxib and other selective COX-2 inhibitors.

This regulatory stiffening rendered tolmetin sodium less attractive due to its comparable risk spectrum, ultimately affecting its market share.

Competitive Landscape

The NSAID market is highly dominated by several key players, including OTC formulations like ibuprofen and naproxen, as well as prescription-only agents such as celecoxib, diclofenac, and meloxicam [2]. The emergence of targeted therapies and biologics for comorbid conditions—like rheumatoid arthritis—which offer alternative mechanisms of action and safety advantages, further constrains tolmetin’s relevance.

Moreover, patent expirations, generic proliferation, and market saturation have diminished prices and profit margins associated with older NSAIDs, including tolmetin sodium.

Prescriber and Patient Preferences

The medical community’s preference for drugs with improved safety profiles and convenience influences prescribing patterns. OTC availability of alternative NSAIDs, coupled with concerns over adverse reactions, results in decreased utilization of tolmetin sodium, especially in high-income markets.

However, in certain regions with limited access to newer drugs, tolmetin may still hold a minor niche, particularly among populations with longstanding therapeutic relationships with older NSAIDs.

Regulatory and Market Access Challenges

Some jurisdictions have restricted or deregistered tolmetin due to safety issues, further curbing market access. Conversely, in markets where regulatory control is less stringent, the drug may still be marketed but with restricted indications and warnings, limiting growth potential.

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Financial Trajectory

Revenue Trends

Historically, tolmetin sodium experienced peak sales in the 1980s and early 1990s, fueled by its initial clinical adoption. However, with increasing safety concerns and competition, revenues have plummeted. Current sales are predominantly in low-income regions or legacy markets, characterized by minimal growth, stagnant or declining sales figures.

Profitability Outlook

Margins are under pressure due to generic competition, reduced prescribing, and safety-related liabilities. Manufacturers face challenges in maintaining profitability while adhering to increasing regulatory compliance costs. The presence of low-cost alternatives further compress pricing and profit margins.

Research and Development (R&D) Investment

Given its diminished commercial appeal, R&D investments into tolmetin sodium have either stagnated or ceased entirely. The focus has shifted towards innovative NSAIDs, biologics, and other pain management therapies exhibiting improved safety profiles and therapeutic efficacy.

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Future Market Outlook

Market Decline and Niche Applications

The overall market trend indicates continued decline for tolmetin sodium, aligned with the global movement towards safer and more effective alternatives. Nevertheless, niche applications—such as in certain low-resource settings or for patients intolerant to newer agents—may sustain minimal demand.

Potential for Reformulation or Repositioning

Specific reformulation strategies, such as targeted delivery systems or combination therapies, could theoretically enhance safety and efficacy, supporting a limited resurgence. However, these approaches would require significant R&D investments with uncertain market acceptance.

Regulatory Dismissal and De-listing Risks

Regulatory developments remain a significant hurdle. Should authorities increasingly restrict the use of older NSAIDs, market viability will further diminish, with potential market exit or de-listing scenarios.

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Prioritize investment in newer NSAIDs and biologics, considering tolmetin sodium’s declining market. Existing suppliers should focus on niche markets and legacy prescribing channels.

• Investors: Recognize that tolmetin sodium’s financial trajectory is predominantly downward. Asset valuation should reflect obsolescence risk, with potential for niche or legacy use but limited growth prospects.

• Regulators and Policymakers: Continued emphasis on safety monitoring and risk mitigation influence market dynamics, favoring drugs with superior safety profiles.

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Key Takeaways

• Tolmetin sodium’s market has contracted significantly due to safety concerns, competition, and regulatory constraints.

• Its financial revenues are in decline, with minimal prospects for substantial growth or reinvention without significant innovation.

• The drug currently exists within a shrinking niche, mainly in underdeveloped or low-resource regions.

• The global shift toward safer NSAIDs and biologics is unlikely to reverse tolmetin’s declining trajectory.

• Stakeholders should consider diversion of investment toward modern therapies with better safety and efficacy profiles for sustained growth.

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FAQs

1. Is tolmetin sodium still available commercially?
In certain markets, tolmetin sodium remains available but often as a legacy product. Its presence is declining globally, especially where newer NSAIDs dominate.

2. What are the primary safety concerns associated with tolmetin sodium?
Like other NSAIDs, tolmetin is associated with gastrointestinal bleeding, cardiovascular risks, and renal impairment, which limit its prescribing.

3. Are there any recent regulatory actions affecting tolmetin sodium?
Regulatory agencies have reinforced warnings for NSAIDs, including tolmetin, leading to more cautious prescribing and, in some cases, withdrawal from certain markets.

4. Can tolmetin sodium be repurposed or reformulated to regain market relevance?
While theoretically possible, significant R&D investment with uncertain outcomes limits this approach. Currently, no such initiatives are publicly known.

5. What therapeutic alternatives have replaced tolmetin sodium?
Selective COX-2 inhibitors like celecoxib, alongside NSAIDs with improved safety profiles, have largely replaced tolmetin for inflammatory and pain management indications.

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References

1. Vallerand, A. H. (2017). "NSAID Safety and Risk Management." Journal of Pain & Palliative Care Pharmacotherapy, 31(3), 142–148.
2. Donnelly, R. A., et al. (2020). "The evolving landscape of NSAIDs in pain management: A safety perspective." Pharmacological Research, 157, 104843.