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Last Updated: December 23, 2024

SODIUM AMINOSALICYLATE Drug Patent Profile


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Which patents cover Sodium Aminosalicylate, and what generic alternatives are available?

Sodium Aminosalicylate is a drug marketed by Hexcel and is included in one NDA.

The generic ingredient in SODIUM AMINOSALICYLATE is aminosalicylate sodium. There are three drug master file entries for this compound. Additional details are available on the aminosalicylate sodium profile page.

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US Patents and Regulatory Information for SODIUM AMINOSALICYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hexcel SODIUM AMINOSALICYLATE aminosalicylate sodium POWDER;ORAL 080097-001 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

SODIUM AMINOSALICYLATE Market Analysis and Financial Projection Experimental

Sodium Aminosalicylate Market Dynamics and Financial Trajectory

Market Overview

Sodium aminosalicylate, a derivative of aminosalicylic acid, is a crucial drug in the treatment of various medical conditions, particularly digestive system disorders such as ulcerative colitis. Here is a comprehensive look at the market dynamics and financial trajectory of this drug.

Market Growth and Projections

The market for sodium aminosalicylate is poised for significant growth over the coming years. According to recent market research, the sodium 4-aminosalicylate market is expected to witness strong growth rates from 2023 to 2031, driven by increasing demand and advancements in healthcare technologies[1][4].

  • CAGR: The global 5-aminosalicylates drugs market, which includes sodium aminosalicylate, is projected to grow at a CAGR of around 3.5% from 2023 to 2031[3].

Market Segmentation

The market for sodium aminosalicylate is segmented based on several key factors:

By Type

  • The market is categorized into crystallization and powder forms. Each form has its specific applications and market demand[1][4].

By Application

  • The primary applications include pharmaceutical raw materials and chemical raw materials. The pharmaceutical segment, particularly for treating ulcerative colitis, dominates the market[1][4].

By Geography

  • The market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America holds a significant share due to advanced healthcare practices and high treatment rates[1][3].

Market Drivers

Several factors are driving the growth of the sodium aminosalicylate market:

Increasing Prevalence of Diseases

  • The rising incidence of ulcerative colitis and other inflammatory bowel diseases is a major driver. These conditions require effective treatments, and sodium aminosalicylate is a first-line treatment for mild to severe ulcerative colitis[3].

Government Initiatives and Healthcare Advancements

  • Government measures to improve healthcare infrastructure and advancements in diagnostic and therapeutic technologies also contribute to market growth[3].

New Product Launches and Strategic Actions

  • Companies are continuously developing new medications and formulations, which is further boosting the market. Strategic actions such as collaborations, mergers, and acquisitions among key players are also significant drivers[1][3].

Market Restraints

Despite the positive outlook, there are some challenges that the market faces:

Regulatory Hurdles

  • Strict regulatory requirements and the need for approvals can slow down the market growth. For instance, the drug's approval status and compliance with regulatory bodies are critical factors[2].

Competition

  • The market is competitive, with several established and emerging players. This competition can lead to pricing pressures and market share challenges[1][3].

Competitive Landscape

The competitive landscape of the sodium aminosalicylate market is diverse and dynamic:

Key Players

  • Companies such as Jacobus Pharmaceutical Co Inc, Eurocept International bv, Harbin Pharmaceutical Group, HUAPONT PHARM, and KAIFENG PHARMACEUTICAL (GROUP) CO., LTD are prominent players in the market[4].
  • Other significant players include FCH Group, Wonda Science, ChemPure, Clearsynth, ABCR, KANTO, Amsyn, Merck, AbMole, and Sandoo Pharmaceuticals And Chemicals[1].

Recent Initiatives and Developments

  • These companies are involved in various initiatives such as new product launches, collaborations, and mergers and acquisitions to strengthen their market position[1][3].

Financial Performance and Projections

Revenue Projections

  • The global sodium 4-aminosalicylate market is expected to grow significantly in terms of revenue during the forecast period from 2023 to 2031. The market size is measured in USD million, and the projections indicate a sustained and significant expansion[1].

Regional Revenue

  • North America dominates the regional revenue share due to better healthcare practices, high treatment rates, and increased prescription of novel medicines. Other regions such as Europe and Asia-Pacific are also expected to contribute substantially to the market growth[1][3].

Therapeutic Areas and Indications

Sodium aminosalicylate is primarily used in the treatment of:

Ulcerative Colitis

  • It is a first-line treatment for mild to severe ulcerative colitis, which is a major indication driving the market[2][3].

Other Indications

  • Although less common, it may also be used in other therapeutic areas such as digestive system disorders and as part of anti-tuberculosis regimens[2][5].

Mechanism of Action and Clinical Significance

Mechanism of Action

  • Sodium aminosalicylate works by inhibiting folic acid synthesis and reducing iron uptake by bacteria, making it bacteriostatic against Mycobacterium tuberculosis[5].

Clinical Significance

  • Its ability to induce remission in ulcerative colitis and its role in preventing bacterial resistance to other antibiotics make it a clinically significant drug[2][5].

Regulatory Status and Approvals

Approval History

  • Sodium aminosalicylate was first approved in the US on March 8, 1950, for the treatment of ulcerative colitis. It has since been approved in various other regions and is classified as an orphan drug in the US[2].

Current Regulatory Status

  • The drug continues to be under regulatory scrutiny, with ongoing clinical trials and updates in its approval status. This ensures its continued use and development in the market[2].

Key Takeaways

  • The sodium aminosalicylate market is expected to grow significantly from 2023 to 2031.
  • The market is driven by increasing prevalence of ulcerative colitis and other inflammatory bowel diseases.
  • North America dominates the regional revenue share.
  • Key players are involved in various strategic initiatives to strengthen their market position.
  • The drug's mechanism of action and clinical significance make it a crucial treatment option.

FAQs

1. What is the primary use of sodium aminosalicylate?

  • Sodium aminosalicylate is primarily used in the treatment of ulcerative colitis and other digestive system disorders.

2. Which region dominates the sodium aminosalicylate market?

  • North America dominates the regional revenue share due to better healthcare practices and high treatment rates.

3. What is the projected CAGR for the sodium aminosalicylate market?

  • The market is projected to grow at a CAGR of around 3.5% from 2023 to 2031.

4. Who are the key players in the sodium aminosalicylate market?

  • Key players include Jacobus Pharmaceutical Co Inc, Eurocept International bv, Harbin Pharmaceutical Group, HUAPONT PHARM, and KAIFENG PHARMACEUTICAL (GROUP) CO., LTD.

5. What are the main drivers of the sodium aminosalicylate market?

  • The main drivers include the increasing prevalence of ulcerative colitis, government initiatives to improve healthcare, and advancements in diagnostic and therapeutic technologies.

Cited Sources:

  1. Market Research Intellect, "Sodium 4-Aminosalicylate Market Size, Scope And Forecast Report".
  2. Synapse, "Sodium Aminosalicylate - Drug Targets, Indications, Patents".
  3. GlobeNewswire, "5-Aminosalicylates Drugs Market Is Projected to increase at a CAGR of around 3.5% during 2023 to 2031".
  4. Valuates Reports, "Sodium 4-Aminosalicylate Market, Report Size, Worth, Revenue".
  5. DrugBank, "Aminosalicylic acid: Uses, Interactions, Mechanism of Action".

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