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, Sun Pharm Industries, and Superpharm, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for SULFASALAZINE

US Patents:	0
Tradenames:	4
Applicants:	9
NDAs:	13
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	100
Patent Applications:	6,953
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
Tanta University	Phase 3
Cairo University	Phase 3
Rutgers, The State University of New Jersey	Phase 2

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
Watson Labs	SULFASALAZINE	sulfasalazine	TABLET;ORAL	087197-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	SULFASALAZINE	sulfasalazine	TABLET, DELAYED RELEASE;ORAL	088052-001	May 24, 1983		DISCN	No	No
Watson Labs	SULFASALAZINE	sulfasalazine	TABLET;ORAL	085828-001	Approved Prior to Jan 1, 1982	AB	RX	No	No
Pfizer	AZULFIDINE	sulfasalazine	TABLET;ORAL	007073-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Pharmacia And Upjohn	AZULFIDINE	sulfasalazine	SUSPENSION;ORAL	018605-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell	SULFASALAZINE	sulfasalazine	TABLET;ORAL	080197-001	Approved Prior to Jan 1, 1982	AB	RX	No	No

SULFASALAZINE Market Analysis and Financial Projection Experimental

Sulfasalazine Market Dynamics and Financial Trajectory

Market Overview

The sulfasalazine market is poised for significant growth, driven by increasing demand for treatments of autoimmune and inflammatory conditions. Sulfasalazine, a disease-modifying antirheumatic drug (DMARD), is primarily used to treat rheumatoid arthritis and inflammatory bowel diseases such as ulcerative colitis and Crohn's disease[1][2][4].

Market Size and Growth Projections

The global sulfasalazine market is expected to expand substantially over the next few years. As of 2023, the market size is valued at approximately $2.01 billion and is projected to reach $2.96 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.7% during the forecast period[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the sulfasalazine market:

Increasing Prevalence of Autoimmune and Gastrointestinal Disorders

The rising incidence of autoimmune and gastrointestinal disorders globally is a significant driver. Conditions such as rheumatoid arthritis, ulcerative colitis, and Crohn's disease are becoming more common, leading to increased demand for sulfasalazine and similar medications[1][2][4].

Aging Population

The aging population, particularly in developed countries, contributes to the market expansion. Older individuals are more susceptible to inflammatory diseases, increasing the need for long-term management and treatment options like sulfasalazine[1].

Advancements in Pharmaceutical Research

Ongoing research and development in the pharmaceutical industry may lead to the introduction of more advanced and effective formulations of sulfasalazine, further propelling market growth[1].

Market Segmentation

The sulfasalazine market is segmented based on several criteria:

Product Type

The market is segmented into generic sulfasalazine and branded sulfasalazine. Generic versions are expected to play a significant role due to their cost-effectiveness[2].

Application

Key applications include rheumatoid arthritis, inflammatory bowel diseases (IBD), Crohn's disease, and ulcerative colitis. The ulcerative colitis segment is expected to hold a major share due to the increasing prevalence and growing awareness of the condition[2].

Distribution Channel

Distribution channels include hospital pharmacies, retail pharmacies, online pharmacies, and specialty clinics. The hospital segment is expected to grow rapidly due to the specialized care and infrastructure available for patients[2].

Regional Insights

The North American region holds a significant revenue share in the sulfasalazine market. This is attributed to the high prevalence of autoimmune disorders, strong healthcare infrastructure, and increased awareness of sulfasalazine in this region. The Asia Pacific region is also anticipated to grow significantly due to rising disposable incomes and increasing healthcare costs[2][4].

Competitive Landscape

The market is competitive with several major players, including Pfizer Inc., Teva Pharmaceuticals, Mylan N.V, Dr. Reddy’s Laboratories, and Zydus Cadila. These companies are focusing on reformulating sulfasalazine, developing extended-release versions, and exploring novel applications to maintain market relevance[2][4].

Challenges and Restraints

Despite the growth potential, the sulfasalazine market faces several challenges:

Generic Competition

The presence of generic versions of sulfasalazine can reduce the market share of branded products[4].

Emergence of Newer Therapies

The introduction of newer, more targeted therapies with potentially fewer side effects can limit the use of sulfasalazine. Adverse reactions such as gastrointestinal disturbances and hypersensitivity are also significant restraints[4].

Impact of the Pandemic

The COVID-19 pandemic disrupted global supply chains, affecting the manufacturing, delivery, and accessibility of medicines, including sulfasalazine. This led to shortages or delays in treatment[2].

Cost-Effectiveness and Economic Impact

Sulfasalazine is considered cost-effective, especially when compared to other treatments for inflammatory bowel diseases. For instance, maintenance therapy with sulfasalazine can cost approximately $640 per flare prevented and $16,300 per quality-adjusted life year (QALY) gained, making it a viable option for long-term management[5].

Emerging Trends and Opportunities

• Combination Therapies: Research into combination therapies involving sulfasalazine and other medications is on the rise, offering potential new treatment options.
• Patient-Centric Care: There is a growing emphasis on patient-centric care, which may impact the market as healthcare providers focus more on biologics and targeted therapies.
• Novel Applications: Exploring sulfasalazine’s potential in treating other autoimmune disorders could open up new market opportunities[4].

Key Takeaways

• The global sulfasalazine market is expected to grow from $2.01 billion in 2023 to $2.96 billion by 2030 at a CAGR of 5.7%.
• The market is driven by the increasing prevalence of autoimmune and gastrointestinal disorders, an aging population, and advancements in pharmaceutical research.
• The North American region holds a significant revenue share, with the Asia Pacific region expected to grow significantly.
• The market faces challenges from generic competition, the emergence of newer therapies, and supply chain disruptions.
• Sulfasalazine remains a cost-effective option for managing inflammatory conditions.

Frequently Asked Questions (FAQs)

1. What is the primary use of sulfasalazine? Sulfasalazine is primarily used to treat inflammatory conditions such as rheumatoid arthritis and inflammatory bowel diseases like ulcerative colitis and Crohn's disease.

2. What is the projected market size of sulfasalazine by 2030? The global sulfasalazine market is expected to reach $2.96 billion by 2030.

3. What are the key drivers of the sulfasalazine market growth? Key drivers include the increasing prevalence of autoimmune and gastrointestinal disorders, an aging population, and advancements in pharmaceutical research.

4. Which region holds the largest market share for sulfasalazine? The North American region currently holds the largest market share for sulfasalazine.

5. What are some of the challenges facing the sulfasalazine market? Challenges include generic competition, the emergence of newer therapies, and disruptions in global supply chains due to the pandemic.

Cited Sources:

1. Coherent Market Insights, "Sulfasalazine Market, By Product Type, By Application, By End User ...", 2023.
2. InsightAce Analytic, "Sulfasalazine Market Share, Size, Growth and Forecast to 2031", 2024.
3. Wicz, "Sulfasalazine Tablets Market Size, Growth Drivers & Global Opportunities 2033".
4. Coherent Market Insights, "Sulfasalazine Market Size & Share Analysis - Coherent Market Insights".
5. PubMed, "Cost-effectiveness of 5-aminosalicylic acid therapy for maintenance of remission in ulcerative colitis", 2008.