Sulindac - Generic Drug Details

What are the generic sources for sulindac and what is the scope of freedom to operate?

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 twelve 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:	12
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	32
Patent Applications:	6,581
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
Johns Hopkins University	Phase 2
Duke 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
Watson Labs	SULINDAC	sulindac	TABLET;ORAL	071891-001	Apr 3, 1990	AB	RX	No	No
Sun Pharm Industries	SULINDAC	sulindac	TABLET;ORAL	072051-001	Apr 17, 1991	AB	RX	No	No
Ani Pharms	SULINDAC	sulindac	TABLET;ORAL	072973-001	Feb 28, 1992		DISCN	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
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-002	Approved Prior to Jan 1, 1982
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-002	Approved Prior to Jan 1, 1982

Sulindac Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Sulindac

Introduction

Sulindac, a nonsteroidal anti-inflammatory drug (NSAID), has been a staple in the treatment of various inflammatory and arthritic conditions since its approval in 1978. This article delves into the market dynamics and financial trajectory of sulindac, exploring its current market size, forecasted growth, key applications, and the companies involved in its production.

Market Size and Forecast

The sulindac market is anticipated to grow at a significant pace over the forecast period of 2024-2031. According to market research, the sulindac market is expected to gain substantial shares during this period, driven by increasing demand for effective treatments for musculoskeletal and arthritic conditions[1].

Key Applications

Sulindac is FDA-approved for several indications, including:

• Acute Management of Musculoskeletal Shoulder Pain: This includes conditions such as acute subacromial bursitis and supraspinatus tendinitis.
• Osteoarthritis: Resulting from wear and tear.
• Rheumatoid Arthritis and Ankylosing Spondylitis: Inflammatory arthritic conditions.
• Acute Gouty Arthritis: Effective in managing acute gout attacks[3].

These broad indications contribute to the drug's steady demand in the market.

Geographical Segmentation

The sulindac market is segmented geographically into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region presents unique market dynamics, with varying levels of demand and growth potential. The Asia-Pacific region, for instance, is expected to show significant growth due to an increasing population and rising healthcare expenditures[1].

Key Companies

Several pharmaceutical companies are involved in the production and distribution of sulindac. Notable players include:

• Merck
• Mylan
• EPIC
• Heritage
• Fuan Pharmaceutical Group
• Ningbo Team Pharmaceutical

These companies play a crucial role in ensuring the availability and quality of sulindac in the global market[1].

Financial Performance

The financial performance of the sulindac market is influenced by several factors, including the demand for NSAIDs, competition from other anti-inflammatory drugs, and regulatory environments.

Revenue Projections

The market size of sulindac is measured in USD million, with projections indicating a steady increase over the forecast period. The revenue growth is driven by the expanding patient population and the need for effective pain management solutions[1].

Cost and Pricing

The cost of sulindac can vary based on the dosage form and the region. The drug is available in 150 mg and 200 mg oral tablets, with a maximum recommended daily dosage of 400 mg. Pricing strategies by pharmaceutical companies also impact the financial trajectory, as they balance profitability with affordability for patients[3].

Competitive Landscape

The NSAID market, where sulindac operates, is highly competitive. Other NSAIDs and newer anti-inflammatory drugs pose competition, but sulindac's established reputation and broad indications help it maintain a significant market share.

Market Share

Companies like Merck and Mylan, which have a strong presence in the pharmaceutical market, contribute significantly to the market share of sulindac. The competitive landscape is also influenced by generic formulations, which offer cost-effective alternatives to branded versions[1].

Regulatory Environment

Regulatory approvals and guidelines play a critical role in the financial trajectory of sulindac. FDA approvals for various indications have expanded the drug's market potential. However, regulatory scrutiny, especially regarding safety and efficacy, can impact the drug's market performance[3].

Safety and Efficacy

Sulindac, like other NSAIDs, is associated with several adverse effects, including gastrointestinal issues, renal impairment, and rare but serious conditions such as liver injury and Stevens-Johnson syndrome. These safety concerns can affect prescribing patterns and, consequently, the financial performance of the drug[3][4].

Off-Label Uses

In addition to its FDA-approved indications, sulindac has off-label uses, such as in the treatment of familial adenomatous polyposis, where it has been shown to decrease adenoma formation. These off-label uses can contribute to the drug's revenue but also come with regulatory and safety implications[3].

Future Outlook

The future outlook for sulindac is positive, driven by the growing need for effective anti-inflammatory treatments. However, the market will need to navigate challenges such as increasing competition from newer drugs and ongoing regulatory scrutiny.

Emerging Trends

Emerging trends in the pharmaceutical industry, such as the development of novel formulations and combination therapies, could impact the market dynamics of sulindac. For example, research on sulindac sulfide has identified potential new applications, such as inhibiting HMGA2, which could expand the drug's therapeutic scope[5].

Key Takeaways

• Growing Market: The sulindac market is expected to grow significantly over the forecast period.
• Broad Indications: Sulindac is approved for various musculoskeletal and arthritic conditions.
• Geographical Segmentation: The market is segmented into several regions, each with unique dynamics.
• Key Players: Companies like Merck and Mylan are major players in the sulindac market.
• Financial Performance: Revenue projections indicate steady growth, influenced by demand and competition.
• Regulatory Environment: FDA approvals and safety guidelines are crucial for the drug's market performance.
• Safety Concerns: Sulindac is associated with several adverse effects that can impact its market.

FAQs

What are the primary indications for sulindac?

Sulindac is primarily indicated for the acute management of musculoskeletal shoulder pain, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute gouty arthritis[3].

Which companies are major producers of sulindac?

Major producers include Merck, Mylan, EPIC, Heritage, Fuan Pharmaceutical Group, and Ningbo Team Pharmaceutical[1].

What are the common side effects of sulindac?

Common side effects include gastrointestinal upset, nausea, abdominal discomfort, diarrhea, and peripheral edema. Rare but serious adverse effects include gastrointestinal ulceration, cardiovascular disease, renal dysfunction, and liver injury[3][4].

How is sulindac administered?

Sulindac is available as 150 mg and 200 mg oral tablets, with a maximum recommended daily dosage of 400 mg. It should be taken with food or milk to decrease gastrointestinal adverse effects[3].

What is the forecasted growth of the sulindac market?

The sulindac market is expected to grow significantly over the forecast period of 2024-2031, driven by increasing demand for effective treatments for musculoskeletal and arthritic conditions[1].

Sources

1. Market Research Intellect, "Global Sulindac Market Size and Forecast," November 2024.
2. Mizuho Securities USA Inc., "No Rosy Outlook for Early 2017; Landscape May Improve Later," December 22, 2016.
3. NCBI Bookshelf, "Sulindac - StatPearls," February 15, 2024.
4. NCBI Bookshelf, "Sulindac - LiverTox," March 20, 2020.
5. MDPI, "Identification of the Effects of Aspirin and Sulindac Sulfide on HMGA2," 2023.