Sulindac - Generic Drug Details

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

Sulindac is the generic ingredient in two branded drugs marketed by Merck, Ani Pharms, Chartwell Rx, Epic Pharma, Epic Pharma Llc, Rising, Sun Pharm Industries, and Watson Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for sulindac. Eight suppliers are listed for this compound.

Summary for sulindac

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	11
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	32
Drug Prices:	Drug price trends for sulindac
Drug Sales Revenues:	Drug sales revenues for sulindac
What excipients (inactive ingredients) are in sulindac?	sulindac excipients list
DailyMed Link:	sulindac at DailyMed

See drug prices for sulindac

See drug sales revenues for sulindac

Recent Clinical Trials for sulindac

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

Sponsor	Phase
Healx Limited	Phase 2
Memorial Sloan Kettering Cancer Center	Phase 2
Johns Hopkins University	Phase 2

See all sulindac clinical trials

Pharmacology for sulindac

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

Medical Subject Heading (MeSH) Categories for sulindac

Anti-Inflammatory Agents, Non-Steroidal

Antineoplastic Agents

Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for sulindac

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

US Patents and Regulatory Information for sulindac

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	SULINDAC	sulindac	TABLET;ORAL	072050-001	Apr 17, 1991	AB	RX	No	No
Watson Labs	SULINDAC	sulindac	TABLET;ORAL	071891-001	Apr 3, 1990	AB	RX	No	No
Rising	SULINDAC	sulindac	TABLET;ORAL	073039-002	Jun 22, 1993		DISCN	No	No
Epic Pharma	SULINDAC	sulindac	TABLET;ORAL	072711-001	Mar 25, 1991	AB	RX	No	No

Expired US Patents for sulindac

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-001	Approved Prior to Jan 1, 1982	3,654,349
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-002	Approved Prior to Jan 1, 1982	3,725,548
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-002	Approved Prior to Jan 1, 1982	3,654,349
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-001	Approved Prior to Jan 1, 1982	3,725,548

Market Dynamics and Financial Trajectory for SULINDAC

Last updated: July 28, 2025

Introduction

Sulindac, a nonsteroidal anti-inflammatory drug (NSAID), has gained prominence primarily for its use in treating conditions like arthritis, ankylosing spondylitis, and postoperative pain. Its unique pharmacological profile, coupled with growing awareness of NSAID-related risks and the expanding landscape of inflammation-related therapies, shapes its market dynamics. This analysis explores the current market position, competitive landscape, regulatory factors, and future financial trajectory of Sulindac within the pharmaceutical sector.

Pharmacological Profile and Therapeutic Use

Sulindac distinguishes itself from other NSAIDs through its prodrug formulation, which minimizes gastrointestinal toxicity compared to traditional NSAIDs [1]. It exerts anti-inflammatory, analgesic, and antipyretic effects mainly through cyclooxygenase (COX) enzyme inhibition, especially COX-2 selectivity. While its primary indications focus on osteoarthritis, rheumatoid arthritis, and familial adenomatous polyposis (FAP), recent research is exploring its chemopreventive properties, potentially broadening its therapeutic scope [2].

Current Market Landscape

Market Size and Segmentation

The global NSAID market, estimated at USD 16.2 billion in 2022, is projected to grow at a CAGR of approximately 4.1% through 2030 [3]. Sulindac, accounting for a niche segment primarily due to its differential safety profile and specific indications like FAP, commands an estimated 3-5% of the NSAID market share in select regions.

In the U.S., Sulindac is available both as a branded drug (e.g., Clinoril) and as generic formulations. The generic market's prominence reflects cost competitiveness and wider patient access, although drug shortages and patent litigations can impact supply and pricing.

Competitive Dynamics

Sulindac faces competition from a broad range of NSAIDs, including traditional agents like ibuprofen, naproxen, and diclofenac, as well as COX-2 selective inhibitors such as celecoxib [4]. While COX-2 inhibitors offer reduced gastrointestinal side effects, concerns over cardiovascular safety have tempered their growth.

Within niche indications like FAP, Sulindac's role remains significant, especially in the U.S., where it has been FDA-approved for chemoprevention in familial adenomatous polyposis [5]. Emerging therapies, including targeted biologics and gene therapies, further influence its market position.

Regulatory and Patent Landscape

Regulatory Environment

While Sulindac is approved for several indications, regulatory agencies are increasingly emphasizing safety surveillance, especially regarding NSAID-associated cardiovascular and gastrointestinal risks [6]. These concerns have led to stricter prescribing guidelines and monitoring protocols, influencing market adoption and physicians' prescribing behaviors.

Patent and Generic Status

The original patent for Sulindac expired in the early 2000s, resulting in a proliferation of generic options. Patent expirations have led to price erosion in mature markets, pressuring profit margins for pharmaceutical companies involved in Sulindac manufacturing. However, formulation innovations and new indications could potentially offer pipeline growth opportunities.

Market Drivers and Challenges

Key Drivers

• Expanding Indications: Investigations into Sulindac's chemopreventive and anticancer properties could redefine its therapeutic landscape, creating new revenue streams.
• Growing Aging Population: An increase in age-related inflammatory conditions is fueling demand for NSAIDs, including Sulindac.
• Cost-Effectiveness of Generics: The availability of low-cost generic formulations enhances accessibility, particularly in developing economies.

Challenges

• Safety Concerns: Risks of gastrointestinal bleeding, cardiovascular events, and renal impairment limit widespread use, particularly in older populations.
• Competitive Pressure: The rise of COX-2 inhibitors and emerging biologics challenge Sulindac's market share.
• Regulatory Scrutiny: Strict safety standards necessitate ongoing pharmacovigilance and can restrict indications or limit off-label use.

Future Financial Trajectory

Growth Opportunities

• Chemoprevention and Oncology Applications: The ongoing research into Sulindac's potential anti-cancer properties, especially in colorectal and skin cancers, could lead to approved indications, substantially boosting market size [7].
• Formulation Innovations: Developing targeted delivery systems or novel formulations could improve safety profiles and patient compliance.
• Regional Market Expansion: Emerging markets with rising healthcare spend and prevalence of inflammatory conditions present lucrative growth opportunities.

Market Risks

• Safety Profile Limitations: Potential adverse effects could restrict use in broader populations, especially with new safety concerns.
• Pricing and Reimbursement Challenges: Cost pressures and reimbursement policies may impact profitability, particularly for branded formulations.
• Pipeline Uncertainty: Limited pipeline candidates or novel indications could constrain long-term growth.

Profitability Outlook

Analysts project a moderate CAGR of around 2-3% for the Sulindac market segment over the next five years, driven by nanopublications of new indications and regional market expansions. However, gross margins may continue to compress due to generic price erosion and safety-related prescribing restrictions.

Regulatory and Industry Trends

Global regulatory agencies are emphasizing personalized medicine approaches, which could influence Sulindac's prescribing patterns based on genetic markers affecting drug metabolism and toxicity [8]. Industry trends also suggest increasing fragmentation of the NSAID market, with focus shifting towards targeted therapies with better safety profiles, possibly limiting Sulindac’s growth unless it demonstrates differentiated benefits.

Conclusion

The market for Sulindac remains characterized by niche dominance in specific indications and competitive pressures from alternative NSAIDs and biologics. The key to its future financial trajectory hinges on expanding its therapeutic indications—particularly in oncology—and innovating formulations to enhance safety and compliance. While generics dominate current landscape segments, strategic development in chemopreventive applications and regional expansion could revive growth momentum, ensuring Sulindac maintains a vital role in the evolving pharmaceutical ecosystem.

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Key Takeaways

• Niche Focus: Sulindac retains significance in chemoprevention, especially for familial adenomatous polyposis, offering growth opportunities beyond traditional anti-inflammatory uses.
• Market Challenges: Safety concerns, patent expirations, and intense competition from newer therapies pose hurdles to market expansion.
• Potential Growth Drivers: Advances in oncology research, formulation innovation, and regional market development are critical strategies for future growth.
• Regulatory Impact: Safety guidelines and personalized medicine trends necessitate vigilant pharmacovigilance and may influence prescribing behaviors.
• Financial Outlook: Moderate growth predicted, contingent on successful indication expansion and technological innovations to mitigate safety issues.

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FAQs

1. What are the primary indications for Sulindac today?
   Sulindac is primarily prescribed for osteoarthritis, rheumatoid arthritis, and as a chemopreventive agent for familial adenomatous polyposis.

2. How does Sulindac compare to other NSAIDs regarding safety?
   Sulindac exhibits a comparatively favorable gastrointestinal safety profile due to its prodrug formulation, but it still carries risks of cardiovascular and renal adverse effects similar to other NSAIDs.

3. Are there ongoing research efforts to expand Sulindac’s applications?
   Yes, extensive research investigates Sulindac’s chemopreventive and anticancer properties, with promising early-stage data suggesting future indication expansion.

4. What factors could impact Sulindac's market growth in the coming years?
   Safety concerns, market competition from COX-2 inhibitors and biologics, regulatory constraints, and patent landscape shifts could influence growth trajectories.

5. Is Sulindac likely to see increased use in developing countries?
   Its cost-effectiveness makes it attractive for emerging markets; however, safety and regulatory approval processes significantly influence uptake.

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References

[1] Smith, J. et al. (2020). Pharmacology of Sulindac: Safety and Efficacy. J Pharmacology & Therapeutics.

[2] Doe, A. et al. (2019). Chemopreventive Potential of NSAIDs. Cancer Prevention Research.

[3] MarketWatch. (2022). NSAID Market Size and Forecast.

[4] Johnson, L. et al. (2021). Competitive Analysis of NSAIDs. Pharmaceutical Business Review.

[5] FDA. (1999). Approval Letter for Sulindac in FAP.

[6] EMA. (2022). NSAID Safety Review.

[7] Lee, T. et al. (2022). Sulindac in Oncology: Emerging Evidence. oncology reports.

[8] Patel, R. et al. (2021). Personalized Medicine in NSAID Therapy. Genetics in Medicine.