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Last Updated: December 22, 2024

SULFASALAZINE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Sulfasalazine

A generic version of SULFASALAZINE was approved as sulfasalazine by WATSON LABS on December 31st, 1969.

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Summary for SULFASALAZINE
Drug patent expirations by year for SULFASALAZINE
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Drug Sales Revenue Trends for SULFASALAZINE

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Recent Clinical Trials for SULFASALAZINE

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

SponsorPhase
Tanta UniversityPhase 3
Cairo UniversityPhase 3
Rutgers, The State University of New JerseyPhase 2

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Pharmacology for SULFASALAZINE
Drug ClassAminosalicylate

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
Nuvo Pharms Inc SULFASALAZINE sulfasalazine TABLET, DELAYED RELEASE;ORAL 075339-001 Jan 11, 2002 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Superpharm SULFASALAZINE sulfasalazine TABLET;ORAL 089339-001 Oct 26, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc SULFASALAZINE sulfasalazine TABLET;ORAL 086184-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

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