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Last Updated: December 23, 2024

POTASSIUM AMINOSALICYLATE - Generic Drug Details


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What are the generic drug sources for potassium aminosalicylate and what is the scope of freedom to operate?

Potassium aminosalicylate is the generic ingredient in two branded drugs marketed by Glenwood and Hexcel, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for POTASSIUM AMINOSALICYLATE
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 24
Patent Applications: 12
DailyMed Link:POTASSIUM AMINOSALICYLATE at DailyMed

US Patents and Regulatory Information for POTASSIUM AMINOSALICYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hexcel POTASSIUM AMINOSALICYLATE potassium aminosalicylate POWDER;ORAL 080098-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glenwood PASKALIUM potassium aminosalicylate TABLET;ORAL 009395-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glenwood PASKALIUM potassium aminosalicylate CAPSULE;ORAL 009395-004 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

POTASSIUM AMINOSALICYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for 5-Aminosalicylates (Including Potassium Aminosalicylate)

Introduction

5-Aminosalicylates, including potassium aminosalicylate, are a class of drugs widely used in the treatment of inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease. These drugs have been a cornerstone in managing IBD due to their anti-inflammatory properties.

Market Overview

The global market for 5-aminosalicylates is projected to grow at a compound annual growth rate (CAGR) of around 3.5% from 2023 to 2031. This growth is driven by several key factors, including the increasing prevalence of IBD and government initiatives to improve healthcare and diagnostic technologies[3].

Market Drivers

  • Increasing Prevalence of IBD: The rising incidence of ulcerative colitis and Crohn's disease is a significant driver of the market. As more people are diagnosed with these conditions, the demand for effective treatments like 5-aminosalicylates increases[3].
  • Advancements in Healthcare: Government measures to enhance healthcare infrastructure and diagnostic capabilities contribute to the market's growth. Better healthcare practices and higher treatment rates, particularly in regions like North America, also play a crucial role[3].
  • Strategic Actions by Market Players: Companies such as Tillotts Pharma AG, WALLACE PHARMA, Takeda Pharmaceutical Company Limited, Abbvie, Inc., and Cosmo Pharmaceuticals NV are actively involved in the market, driving growth through various strategic initiatives[3].

Market Segmentation

The global 5-aminosalicylates market is segmented based on type, indication, and region. Here are some key segments:

  • Type: This includes different formulations of 5-aminosalicylates such as oral and rectal preparations.
  • Indication: The primary indications are ulcerative colitis and Crohn's disease.
  • Region: North America dominates the market due to better healthcare practices, high treatment rates, and the presence of strong market players[3].

Financial Trajectory

Healthcare Financial Charges

Patients with IBD, particularly those treated with 5-aminosalicylates, incur significant healthcare costs. Here are some financial trajectory insights:

  • Direct and Indirect Costs: Patients with IBD have more than three times higher direct healthcare costs compared to non-IBD controls, with annual costs averaging $22,987 per patient. Out-of-pocket costs are also significantly higher, averaging $2,213 per year[5].
  • Cost Drivers: The costs are driven by specific therapeutics, emergency department use, and health services associated with relapsing disease, anemia, or mental health comorbidities. The first year after diagnosis is particularly costly, with a mean cost of $26,555[5].

Market Revenue

The global 5-aminosalicylates market is expected to see significant revenue growth. Here are some key financial metrics:

  • Revenue Growth: The market is projected to grow at a CAGR of 3.5% from 2023 to 2031, driven by the increasing prevalence of IBD and other market drivers[3].
  • Regional Revenue: North America accounts for the largest revenue share due to its advanced healthcare practices and high treatment rates. Other regions, including Europe, Asia Pacific, Latin America, and the Middle East & Africa, also contribute to the market revenue[3].

Cost-Effectiveness and Patient Impact

Treatment Costs

5-Aminosalicylates are generally well-tolerated and cost-effective compared to other IBD treatments like biologics. Here are some cost considerations:

  • Dosing and Costs: The suggested dosing for oral mesalamine, a common 5-aminosalicylate, ranges from 60–80 mg/kg/day to 4.8 g daily. Rectal mesalamine and sulfasalazine also have specific dosing recommendations. These treatments are often more affordable than biologic therapies[4].
  • Continuation During Pregnancy: 5-Aminosalicylates can be safely continued during pregnancy, which helps in maintaining consistent treatment and reducing overall healthcare costs associated with managing IBD during pregnancy[4].

Quality of Life and Healthcare Utilization

Patients on 5-aminosalicylates often experience better quality of life and reduced healthcare utilization compared to those on more aggressive treatments:

  • Healthcare Utilization: Patients with consistently high healthcare charges, often associated with more severe IBD, have higher rates of hospitalization, surgery, and use of corticosteroids and antitumor necrosis factor agents. In contrast, those on effective 5-aminosalicylate therapy may have lower healthcare utilization and better quality of life[2].

Competitive Landscape

The market for 5-aminosalicylates is competitive, with several key players:

  • Major Players: Companies like Tillotts Pharma AG, WALLACE PHARMA, Takeda Pharmaceutical Company Limited, Abbvie, Inc., and Cosmo Pharmaceuticals NV are prominent in the market. These companies engage in various strategic actions to maintain and expand their market share[3].

Future Outlook

The future outlook for the 5-aminosalicylates market is positive, driven by the increasing demand for effective IBD treatments and advancements in healthcare.

  • Market Growth: The market is expected to continue growing at a CAGR of 3.5% from 2023 to 2031, driven by the factors mentioned above[3].
  • Innovations and Research: Ongoing research into the mechanisms of action of 5-aminosalicylates, such as their interaction with PPAR-γ, may lead to more targeted and effective treatments, further driving market growth[1].

Key Takeaways

  • The global 5-aminosalicylates market is projected to grow at a CAGR of 3.5% from 2023 to 2031.
  • The market is driven by the increasing prevalence of IBD and government initiatives to improve healthcare.
  • North America dominates the market due to better healthcare practices and high treatment rates.
  • 5-Aminosalicylates are cost-effective and generally well-tolerated, making them a preferred first-line treatment for IBD.
  • The competitive landscape includes major players like Tillotts Pharma AG, WALLACE PHARMA, and Takeda Pharmaceutical Company Limited.

FAQs

Q: What is the primary use of 5-aminosalicylates in healthcare? A: 5-Aminosalicylates are primarily used in the treatment of inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease.

Q: What drives the growth of the 5-aminosalicylates market? A: The growth is driven by the increasing prevalence of IBD, government initiatives to improve healthcare, and advancements in diagnostic technologies.

Q: Which region dominates the 5-aminosalicylates market? A: North America dominates the market due to its advanced healthcare practices, high treatment rates, and the presence of strong market players.

Q: How do 5-aminosalicylates affect healthcare costs for IBD patients? A: 5-Aminosalicylates are generally cost-effective and can reduce overall healthcare costs by managing IBD effectively, thereby reducing the need for more expensive treatments and hospitalizations.

Q: Are 5-aminosalicylates safe during pregnancy? A: Yes, 5-aminosalicylates are safe to continue during pregnancy as available evidence does not suggest adverse fetal outcomes[4].

Sources

  1. Intestinal antiinflammatory effect of 5-aminosalicylic acid is mediated by PPAR-γ activation.
  2. Group-Based Trajectory Modeling of Healthcare Financial Charges for Patients with Inflammatory Bowel Disease.
  3. 5-Aminosalicylates Drugs Market Is Projected to increase at a CAGR of around 3.5% during 2023 to 2031: Exclusive report by Growth Plus Reports.
  4. Colitis and Crohn's Foundation (India) consensus statements on use of aminosalicylates.
  5. Cost of Inflammatory Bowel Disease: An Initiative From the Crohn's & Colitis Foundation.

More… ↓

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