Sulfasalazine - Generic Drug Details

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

Sulfasalazine is the generic ingredient in four branded drugs marketed by Pharmacia And Upjohn, Pfizer, Nuvo Pharms Inc, Watson Labs, Solvay, Chartwell, Epic Pharma Llc, Rising, Sun Pharm Industries, and Superpharm, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for sulfasalazine. Ten suppliers are listed for this compound.

Summary for sulfasalazine

US Patents:	0
Tradenames:	4
Applicants:	10
NDAs:	14
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	107
Patent Applications:	7,601
Drug Prices:	Drug price trends for sulfasalazine
What excipients (inactive ingredients) are in sulfasalazine?	sulfasalazine excipients list
DailyMed Link:	sulfasalazine at DailyMed

See drug prices for sulfasalazine

See drug sales revenues for sulfasalazine

Recent Clinical Trials for sulfasalazine

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

Sponsor	Phase
NYU Langone Health	PHASE2
Tianjin Medical University Cancer Institute and Hospital	PHASE2
Jilin City Hospital of Chemical Industry	PHASE2

See all sulfasalazine clinical trials

Pharmacology for sulfasalazine

Drug Class

Aminosalicylate

Medical Subject Heading (MeSH) Categories for sulfasalazine

Anti-Infective Agents

Anti-Inflammatory Agents, Non-Steroidal

Antirheumatic Agents

Gastrointestinal Agents

Anatomical Therapeutic Chemical (ATC) Classes for sulfasalazine

A07EC	Aminosalicylic acid and similar agents
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for sulfasalazine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Solvay	S.A.S.-500	sulfasalazine	TABLET;ORAL	083450-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	AZULFIDINE EN-TABS	sulfasalazine	TABLET, DELAYED RELEASE;ORAL	007073-002	Apr 6, 1983	AB	RX	Yes	Yes
Nuvo Pharms Inc	SULFASALAZINE	sulfasalazine	TABLET;ORAL	040349-001	Jan 11, 2002	AB	RX	No	No
Nuvo Pharms Inc	SULFASALAZINE	sulfasalazine	TABLET, DELAYED RELEASE;ORAL	075339-001	Jan 11, 2002	AB	RX	No	No
Watson Labs	SULFASALAZINE	sulfasalazine	TABLET;ORAL	084964-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Superpharm	SULFASALAZINE	sulfasalazine	TABLET;ORAL	089339-001	Oct 26, 1987		DISCN	No	No

Market Dynamics and Financial Trajectory for SULFASALAZINE

Last updated: July 27, 2025

Introduction

Sulfasalazine, a disease-modifying anti-rheumatic drug (DMARD), has maintained relevance in the management of inflammatory bowel disease (IBD) and rheumatoid arthritis (RA). Originally developed in the 1950s, it has a long-standing history in pharmacotherapy. As demand for targeted, affordable treatments persists, understanding its market dynamics and financial trajectory is vital for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Pharmacological Profile and Clinical Utility

Sulfasalazine is a prodrug that metabolizes into 5-aminosalicylic acid (5-ASA) and sulfapyridine, exerting anti-inflammatory effects mainly in the gastrointestinal tract. Its primary indications include ulcerative colitis and Crohn's disease, with secondary use in RA. Its efficacy, safety profile, and cost-effectiveness underpin its continued utilization, especially in regions with limited access to biologics.

Market Landscape and Competitive Positioning

Key Market Players

Major pharmaceutical manufacturers such as CDA Therapeutics, Solco Healthcare, and Teva Pharmaceuticals produce sulfasalazine formulations. Generic versions dominate the market globally, driven by extensive patent expirations and regulatory approvals worldwide. The widespread availability of generics has significantly suppressed prices, constraining revenue potential but expanding accessibility.

Market Drivers

• Prevalence of IBD and RA: Rising incidence rates across North America, Europe, and Asia-Pacific sustain steady demand.
• Cost-Effectiveness: Sulfasalazine remains a preferred option in low- and middle-income countries due to its affordability compared to biologic therapies.
• Guideline Recommendations: Clinical guidelines continue endorsing sulfasalazine as first-line or adjunct therapy in specific cases of RA and IBD.
• Patient and Physician Preference: A long-established safety profile and familiarity support ongoing use.

Market Challenges

• Emergence of Biologics: Monoclonal antibodies and targeted DMARDs have demonstrated superior efficacy in some cases, leading to decreased sulfasalazine utilization.
• Toxicity Profile: Potential adverse effects, including hypersensitivity reactions, hepatotoxicity, and hematological issues, restrict widespread long-term use.
• Patient Compliance: Side effects such as gastrointestinal discomfort and alopecia may impact adherence.

Market Dynamics Influences

Regulatory Environment

Global regulatory agencies, including the FDA and EMA, continue to approve generic sulfasalazine formulations. They impose strict quality control, which sustains competition but also limits differentiation. Regulatory pathways for new formulations or combination therapies are complex, impacting innovation.

Pricing and Reimbursement Policies

In markets with government-controlled pricing and reimbursement schemes, sulfasalazine's affordability maintains its position. However, price pressures and reimbursement limitations in certain regions may constrain revenue growth.

Innovation and Formulation Developments

Current trends focus on improving formulations—such as extended-release or enteric-coated tablets—to enhance patient tolerability and compliance. Some research explores combination therapies or derivatives, but widespread adoption remains nascent.

Financial Trajectory and Revenue Outlook

Historical Revenue Analysis

The global sulfasalazine market was valued at approximately USD 200 million in 2022, with steady growth driven predominantly by emerging markets. The revenue is underpinned by generic sales, with minimal branded premiums due to extensive patent expiries.

Forecast and Future Trends

Analysts project a compound annual growth rate (CAGR) of 2-3% over the next five years, primarily sustained by the increasing prevalence of IBD and RA. However, this growth is constrained by market saturation and competition from biologics.

Revenue Impact of Market Dynamics

• Pricing Pressures: Competitive generics reduce profit margins.
• Market Penetration: Expanding into under-served regions could offset mature-market stagnation.
• Therapeutic Alternatives: Rising confidence in biologic treatments may gradually supplant sulfasalazine use, especially in high-income markets.

Regional Market Insights

• North America: Despite mature markets, the high prevalence of RA and IBD sustains steady demand. However, biologics' dominance limits upside.
• Europe: Similar trends as North America, with regulatory constraints fostering generics' prominence.
• Asia-Pacific: Rapidly growing markets with increasing disease prevalence and cost sensitivity favor sulfasalazine's use, promising higher growth potential.
• LATAM and Africa: Lower treatment penetration and economic constraints maintain a steady or modest market size.

Market Entry Strategies

To capitalize on sulfasalazine's market potential, pharmaceutical companies focus on:

• Differentiated Formulations: Developing improved-tolerability versions.
• Market Expansion: Targeting regions with limited access to advanced therapies.
• Cost-Effective Packaging and Pricing: Ensuring affordability in price-sensitive markets.
• Partnerships and Collaborations: Working with local distributors and healthcare providers to increase distribution channels.

Conclusion

Sulfasalazine's market characteristics are shaped by its longstanding clinical utility, generic availability, and the evolving treatment landscape for IBD and RA. While current revenue growth is modest due to market saturation and competition from novel agents, targeted strategies focused on emerging markets and formulation innovations can bolster its financial trajectory. The drug’s role remains critical in resource-constrained settings, implying a continued, albeit moderated, market presence.

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Key Takeaways

• Steady Demand: Sulfasalazine’s affordability and existing clinical guidelines uphold its relevance in IBD and RA treatment worldwide.
• Competition from Biologics: Innovations in therapies pose a risk to sulfasalazine’s market share, especially in high-income regions.
• Regional Variations: Emerging markets present growth opportunities due to rising disease prevalence and cost considerations.
• Price Sensitivity: Generics dominate, leading to suppressed profit margins but wider access.
• Innovative Formulations: Development of better-tolerated or extended-release versions can sustain interest and expand patient adherence.

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FAQs

1. How does the patent status impact the sulfasalazine market?
Patent expirations in the past have facilitated widespread generic manufacturing, decreasing prices and limiting profit margins but broadening access globally.

2. What are the main competitors to sulfasalazine in the treatment of IBD and RA?
Biologics such as infliximab, adalimumab, and newer small molecules like tofacitinib offer superior efficacy in some cases, challenging sulfasalazine’s position.

3. Are there ongoing innovations or formulations that could extend sulfasalazine’s market life?
Yes, extended-release formulations and combination therapies are under investigation to improve tolerability and adherence, potentially extending its market viability.

4. How region-specific factors influence sulfasalazine’s market?
In low- and middle-income countries, cost-effective, easily accessible generics favor sulfasalazine. Conversely, in high-income regions, biologics’ superior efficacy may diminish its use.

5. What strategic moves can pharmaceutical companies adopt to maximize sulfasalazine’s market share?
Developing improved formulations, expanding into underserved markets, and implementing competitive pricing strategies are effective approaches.

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References

1. [1] Global Market Insights, “Pharmaceutical Drugs Market Report,” 2022.
2. [2] World Health Organization, “Prevalence and Incidence of Inflammatory Bowel Disease,” 2021.
3. [3] FDA Database, “Approved Generic Drugs,” 2022.
4. [4] Clinical guidelines from the American College of Rheumatology, 2021.
5. [5] Pharma intelligence, “Biologic Therapies in Rheumatology,” 2022.