AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID - Generic Drug Details

What are the generic sources for aminosalicylate sodium; aminosalicylic acid and what is the scope of patent protection?

Aminosalicylate sodium; aminosalicylic acid is the generic ingredient in one branded drug marketed by Medpointe Pharm Hlc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID at DailyMed

US Patents and Regulatory Information for AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medpointe Pharm Hlc	NEOPASALATE	aminosalicylate sodium; aminosalicylic acid	TABLET;ORAL	080059-002	Approved Prior to Jan 1, 1982		DISCN	No	No

AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aminosalicylates: A Comprehensive Overview

Introduction to Aminosalicylates

Aminosalicylates, including sodium 4-aminosalicylate and aminosalicylic acid, are a class of drugs that play a crucial role in managing various medical conditions, particularly inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease, as well as tuberculosis.

Market Size and Growth Projections

The market for aminosalicylates is experiencing significant growth, driven by several key factors.

• Sodium 4-Aminosalicylate Market: This market is anticipated to witness substantial growth from 2023 to 2031, with strong growth rates expected due to increasing demand in pharmaceutical and chemical raw materials sectors. The market is segmented by type (crystallization, powder) and application (pharmaceutical raw materials, chemical raw materials), with geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa contributing to its expansion[1].

• 5-Aminosalicylates Drugs Market: The global 5-aminosalicylates drugs market is projected to grow at a Compound Annual Growth Rate (CAGR) of around 3.5% from 2023 to 2031. This growth is largely driven by the increasing prevalence of ulcerative colitis and Crohn's disease, as well as advancements in healthcare and diagnostic technologies[4].

Key Drivers of Market Growth

Several factors are driving the growth of the aminosalicylates market:

• Increasing Prevalence of IBD: The rising number of patients with ulcerative colitis and Crohn's disease is a significant driver. In the United States, for example, over 1.6 million individuals are affected by IBD, with around 70,000 new cases diagnosed annually[4].

• Advancements in Healthcare: Government initiatives to improve healthcare infrastructure and the development of new diagnostic and therapeutic technologies are also contributing to market growth[4].

• First-Line Treatment: 5-Aminosalicylates are often the first-line treatment for mild to severe ulcerative colitis, which further boosts their demand[4].

Market Segmentation

The aminosalicylates market is segmented in various ways to understand its dynamics better:

• By Type: The 5-aminosalicylates market is segmented into sulfasalazine, mesalazine, olsalazine, and others. For sodium 4-aminosalicylate, the segmentation is based on crystallization and powder forms[1][4].

• By Indication: The market is primarily segmented into ulcerative colitis, inflammatory bowel disease, and other indications. Ulcerative colitis dominates the market due to a large patient pool and the introduction of new medications[4].

• By Region: North America holds the largest revenue share due to better healthcare practices, high treatment rates, and the presence of strong market participants. Other regions such as Europe, Asia-Pacific, South America, and the Middle-East and Africa also contribute significantly to the market[1][4].

Financial Trajectory

The financial outlook for the aminosalicylates market is promising:

• Revenue Growth: The 5-aminosalicylates drugs market is expected to increase significantly, with a CAGR of 3.5% from 2023 to 2031. This translates into substantial revenue growth over the forecast period[4].

• Cost-Effectiveness: While maintenance therapy with 5-aminosalicylates can be costly, it is often cost-effective, especially when compared to other treatments. For instance, maintenance 5-ASA therapy can cost around $640 per flare prevented and $16,300 per quality-adjusted life-year (QALY) gained, which is relatively favorable depending on societal willingness to pay[2].

Competitive Landscape

The market for aminosalicylates is competitive, with several key players:

• Major Players: Companies such as Tillotts Pharma AG, WALLACE PHARMA, Takeda Pharmaceutical Company Limited, Abbvie, Inc., and Cosmo Pharmaceuticals NV are prominent in the global 5-aminosalicylates market[4].

• Market Strategies: These companies are involved in various strategic actions, including the development of new medications, mergers and acquisitions, and regional expansions to maintain their market share and drive growth.

Clinical Use and Mechanism of Action

Aminosalicylates are used in various clinical settings:

• Ulcerative Colitis: Drugs like mesalamine (a form of 5-aminosalicylic acid) are effective in inducing and maintaining remission in ulcerative colitis. Clinical studies have shown that mesalamine delayed-release tablets are effective in treating mildly to moderately active ulcerative colitis and in maintaining remission[3].

• Tuberculosis: Aminosalicylic acid is used as an anti-mycobacterial agent in combination with other drugs for treating tuberculosis. It inhibits folic acid synthesis and the synthesis of the cell wall component mycobactin, thus reducing iron uptake by Mycobacterium tuberculosis[5].

Challenges and Opportunities

Despite the positive outlook, the market faces some challenges and opportunities:

• Challenges: The cost of maintenance therapy can be substantial, and the market is sensitive to factors such as the cost of the drug, the risk reduction of flares, and patient preferences[2].

• Opportunities: The increasing prevalence of IBD and advancements in healthcare technologies present significant opportunities for market growth. Additionally, the introduction of new medications and the expansion into new geographical regions can further drive the market[4].

Regulatory and Approval Processes

The approval and regulatory processes for aminosalicylates are stringent:

• FDA Approvals: Drugs like DELZICOL (mesalamine delayed-release tablets) have undergone rigorous clinical trials and have been approved by regulatory bodies such as the FDA for the treatment of mildly to moderately active ulcerative colitis and the maintenance of remission[3].

Patient Preferences and Quality of Life

Patient preferences play a crucial role in the cost-effectiveness and adoption of aminosalicylate therapies:

• Quality of Life: The quality of life while taking maintenance 5-ASA therapy is a critical factor in determining its cost-effectiveness. Patients' preferences regarding the benefits and side effects of the therapy can significantly influence the market dynamics[2].

Regional Growth Analytics

The regional performance of the aminosalicylates market varies:

• North America: This region dominates the market due to better healthcare practices, high treatment rates, and the presence of strong market participants[4].

• Other Regions: Europe, Asia-Pacific, South America, and the Middle-East and Africa also contribute to the market growth, with varying levels of healthcare infrastructure and patient populations.

Key Takeaways

• Growing Market: The aminosalicylates market is expected to grow significantly, driven by the increasing prevalence of IBD and advancements in healthcare.
• Cost-Effectiveness: Maintenance therapy with 5-aminosalicylates can be cost-effective, despite its initial costs.
• Competitive Landscape: The market is competitive, with several key players involved in strategic actions to drive growth.
• Clinical Use: Aminosalicylates are effective in treating ulcerative colitis and tuberculosis, with a well-understood mechanism of action.
• Regional Variations: The market performance varies by region, with North America leading due to better healthcare practices.

FAQs

What is the primary use of aminosalicylates in clinical settings?

Aminosalicylates, such as mesalamine, are primarily used to induce and maintain remission in ulcerative colitis and to treat tuberculosis.

Which region dominates the global 5-aminosalicylates market?

North America dominates the global 5-aminosalicylates market due to better healthcare practices, high treatment rates, and the presence of strong market participants.

What is the expected CAGR for the 5-aminosalicylates drugs market from 2023 to 2031?

The 5-aminosalicylates drugs market is projected to grow at a CAGR of around 3.5% from 2023 to 2031.

How does the cost of maintenance 5-ASA therapy compare to other treatments?

Maintenance 5-ASA therapy can be costly but is often cost-effective, with costs such as $640 per flare prevented and $16,300 per QALY gained, which is relatively favorable depending on societal willingness to pay.

What are the key drivers of the aminosalicylates market growth?

The key drivers include the increasing prevalence of IBD, advancements in healthcare technologies, and the introduction of new medications.

Sources

1. Market Research Intellect: Sodium 4-Aminosalicylate Market Size, Scope And Forecast Report.
2. PubMed: Cost-effectiveness of 5-aminosalicylic acid therapy for maintenance of ulcerative colitis.
3. FDA: Approval Package for DELZICOL.
4. GlobeNewswire: 5-Aminosalicylates Drugs Market Is Projected to increase at a CAGR of around 3.5% during 2023 to 2031.
5. DrugBank: Aminosalicylic acid: Uses, Interactions, Mechanism of Action.