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Last Updated: December 22, 2024

AZULFIDINE Drug Patent Profile


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When do Azulfidine patents expire, and when can generic versions of Azulfidine launch?

Azulfidine is a drug marketed by Pharmacia And Upjohn and Pfizer and is included in two NDAs.

The generic ingredient in AZULFIDINE is sulfasalazine. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Azulfidine

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

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Summary for AZULFIDINE
Drug patent expirations by year for AZULFIDINE
Drug Prices for AZULFIDINE

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Recent Clinical Trials for AZULFIDINE

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

SponsorPhase
University of Erlangen-Nürnberg Medical SchoolPhase 3
Columbia UniversityPhase 4
Brigham and Women's HospitalPhase 4

See all AZULFIDINE clinical trials

Pharmacology for AZULFIDINE
Drug ClassAminosalicylate

US Patents and Regulatory Information for AZULFIDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn AZULFIDINE sulfasalazine SUSPENSION;ORAL 018605-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer AZULFIDINE sulfasalazine TABLET;ORAL 007073-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer AZULFIDINE EN-TABS sulfasalazine TABLET, DELAYED RELEASE;ORAL 007073-002 Apr 6, 1983 AB RX Yes Yes ⤷  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

AZULFIDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Sulfasalazine (Azulfidine)

Introduction

Sulfasalazine, commonly known by the brand name Azulfidine, is an anti-inflammatory drug used to treat various autoimmune and inflammatory conditions, including rheumatoid arthritis, inflammatory bowel diseases (IBD), Crohn's disease, and ulcerative colitis. Here, we delve into the market dynamics and financial trajectory of this crucial pharmaceutical.

Market Size and Growth

The global sulfasalazine market is experiencing significant growth. As of 2022, the market size was valued at USD 2.02 billion and is projected to reach USD 3.13 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.2% during the forecast period from 2023 to 2031[1][4].

Drivers of Market Growth

Several factors are driving the growth of the sulfasalazine market:

Increasing Prevalence of Inflammatory Bowel Diseases

The rising incidence of IBD, including ulcerative colitis and Crohn's disease, is a major driver. These conditions are becoming more common in both developed and developing countries due to changes in diet, lifestyle, and environmental factors[1][4].

Public Awareness and Advanced Treatments

Increased public awareness of these conditions and the introduction of cutting-edge treatments are also contributing to market expansion. Regulatory approvals and inclusion in treatment recommendations further solidify sulfasalazine's position in the market[1].

Healthcare Infrastructure

The strong healthcare infrastructure in regions like North America, coupled with rising disposable incomes and healthcare costs, is another significant factor. This infrastructure supports the demand for sulfasalazine, particularly in hospitals where specialized care is provided[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 increasingly popular due to their cost-effectiveness, although branded versions still hold a significant market share[1][4].

Application

Sulfasalazine is used in treating various conditions, including rheumatoid arthritis, inflammatory bowel diseases, Crohn's disease, and ulcerative colitis. The ulcerative colitis category is expected to hold a major share due to the increasing prevalence and growing awareness of the condition[1].

Distribution Channel

The distribution channels include hospital pharmacies, retail pharmacies, online pharmacies, and specialty clinics. Hospitals are expected to grow at a rapid rate due to their specialized care and infrastructure for intravenous delivery of sulfasalazine when oral delivery is not feasible[1].

Competitive Landscape

The sulfasalazine market is highly competitive with several key players:

  • Pfizer Inc.
  • Teva Pharmaceuticals
  • Mylan N.V
  • Dr Reddy's Laboratories
  • Zydus Cadila
  • Sun Pharmaceutical Industries
  • Aspen Pharmacare
  • Apotex Inc.
  • Sandoz (a division of Novartis)
  • Lupin Limited[1][4].

Regional Insights

The North American region holds a significant revenue share in the sulfasalazine market. This is due to the high prevalence of autoimmune disorders such as inflammatory bowel disease and rheumatoid arthritis, along with strong awareness and established healthcare infrastructure in the region. The Asia Pacific region is also anticipated to grow significantly due to rising disposable incomes and increasing awareness of sulfasalazine[1][4].

Financial Trajectory

Revenue Projections

The global sulfasalazine market is expected to grow from USD 2.01 billion in 2023 to USD 2.96 billion by 2030, at a CAGR of 5.7% during the forecast period[4].

Economic Impact

The economic burden of treating conditions like rheumatoid arthritis, which often involves sulfasalazine, is significant. For instance, the direct costs for RA patients increased by 75% from 2008 to 2020, primarily driven by rising prescription drug costs[2].

Cost-Effectiveness

Despite the emergence of newer, more targeted therapies, sulfasalazine remains a cost-effective option. However, it faces competition from generic versions and newer treatments with potentially fewer side effects. The focus on patient-centric care and biologics may impact its market relevance, but its cost-effectiveness keeps it a preferred choice in certain regions and healthcare settings[4].

Challenges and Restraints

Generic Competition

The market faces significant competition from generic sulfasalazine, which can reduce the market share of branded versions[1][4].

Adverse Reactions

Sulfasalazine is associated with adverse reactions such as gastrointestinal disturbances and hypersensitivity, which can limit its use[4].

Pandemic Impact

The COVID-19 pandemic disrupted global supply chains, affecting the manufacturing, delivery, and accessibility of medicines, including sulfasalazine. This disruption could have caused shortages or delays in treatment[1].

Emerging Trends

Combination Therapies

Research into combination therapies and exploring sulfasalazine’s potential in treating other autoimmune disorders is an emerging trend. This could expand the drug's market relevance and efficacy[4].

Patient-Centric Care

The growing emphasis on patient-centric care and the development of biologics and targeted therapies may influence the market dynamics of sulfasalazine. Adapting to these changing treatment paradigms will be crucial for sustaining its market position[4].

Key Takeaways

  • The sulfasalazine market is projected to grow significantly due to the increasing prevalence of IBD and other autoimmune conditions.
  • The North American region holds a significant market share due to high awareness and strong healthcare infrastructure.
  • Generic competition and adverse reactions are key challenges facing the market.
  • Emerging trends include research into combination therapies and a focus on patient-centric care.
  • Sulfasalazine remains a cost-effective option despite the emergence of newer therapies.

FAQs

What is the current market size of sulfasalazine?

The current market size of sulfasalazine is valued at USD 2.02 billion as of 2022[1].

What is the projected growth rate of the sulfasalazine market?

The sulfasalazine market is expected to grow at a CAGR of 5.2% from 2023 to 2031[1].

Which region holds the largest market share for sulfasalazine?

The North American region holds the largest market share for sulfasalazine due to the high prevalence of autoimmune disorders and strong healthcare infrastructure[1].

What are the main applications of sulfasalazine?

Sulfasalazine is primarily used to treat rheumatoid arthritis, inflammatory bowel diseases, Crohn's disease, and ulcerative colitis[1].

What are the major challenges facing the sulfasalazine market?

The major challenges include generic competition, adverse reactions, and the emergence of newer, more targeted therapies[1][4].

How has the COVID-19 pandemic affected the sulfasalazine market?

The pandemic has disrupted global supply chains, affecting the manufacturing, delivery, and accessibility of sulfasalazine, leading to potential shortages or delays in treatment[1].

Sources

  1. InsightAce Analytic: Sulfasalazine Market Share, Size, Growth and Forecast to 2031.
  2. Auburn University: Studies on Expenditure, Prices, and Value of Disease-Modifying Antirheumatic Drugs.
  3. PLOS ONE: Budget impact analysis of subcutaneous infliximab (CT-P13 SC) for ulcerative colitis and Crohn’s disease in Saudi Arabia.
  4. Coherent Market Insights: Sulfasalazine Market Size & Share Analysis.

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