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Last Updated: December 22, 2024

APHTHASOL Drug Patent Profile


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

Aphthasol is a drug marketed by Uluru and is included in one NDA.

The generic ingredient in APHTHASOL is amlexanox. Additional details are available on the amlexanox profile page.

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Summary for APHTHASOL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 124
Patent Applications: 1,670
DailyMed Link:APHTHASOL at DailyMed
Drug patent expirations by year for APHTHASOL

US Patents and Regulatory Information for APHTHASOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Uluru APHTHASOL amlexanox PASTE;DENTAL 020511-001 Dec 17, 1996 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

APHTHASOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amlexanox (Aphthasol)

Introduction

Amlexanox, marketed under the brand name Aphthasol, is a medication primarily used for the treatment of aphthous ulcers, also known as canker sores. This article delves into the market dynamics and financial trajectory of amlexanox, providing insights into its applications, market segments, key players, and future projections.

Market Size and Forecast

The global amlexanox market is anticipated to grow significantly over the forecast period of 2024-2031. According to market research reports, the market is expected to gain substantial shares due to increasing demand for effective treatments for aphthous ulcers and other inflammatory conditions[1][4].

Market Segmentation

The amlexanox market is segmented based on several key factors:

By Application

  • Recurrent Aphthous Ulcers: This is the primary application of amlexanox, where it is used to accelerate the healing of canker sores.
  • Inflammatory Conditions: Amlexanox is also used to treat various inflammatory conditions in the oral cavity.
  • Apthous Stomatitis: This condition involves inflammation of the mucous membranes in the mouth, for which amlexanox is prescribed[1][4].

By Product

  • Pasta: Amlexanox is available in the form of an adhesive oral paste, known as Aphthasol.
  • Oral Adhesive Tablets: Though less common, amlexanox can also be formulated into oral adhesive tablets for easier administration[1][4].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics influenced by local healthcare policies, patient demographics, and economic factors[1][4].

Key Players

The amlexanox market is dominated by several key players:

  • Amlexanox: The generic version of the drug.
  • Uluru Inc: Known for its innovative pharmaceutical products.
  • Chemex Pharmaceuticals: A company specializing in various pharmaceutical formulations.
  • Block Drug: The company behind the branded version, Aphthasol[1][4].

Market Dynamics

Drivers

  • Increasing Prevalence of Aphthous Ulcers: The rising incidence of canker sores and other oral inflammatory conditions drives the demand for amlexanox.
  • Effective Treatment: Clinical studies have shown that amlexanox significantly accelerates the healing of aphthous ulcers and reduces pain, making it a preferred treatment option[5].

Restraints

  • Limited Indications: Amlexanox is primarily indicated for aphthous ulcers and a few other inflammatory conditions, limiting its market scope.
  • Contraindications: The drug is contraindicated in patients with known hypersensitivity to amlexanox, which can restrict its use in certain patient populations[5].

Opportunities

  • Expanding into New Markets: There is potential for growth in emerging markets where access to effective treatments for oral ulcers is limited.
  • Research and Development: Further research could expand the indications for amlexanox, potentially increasing its market share[1][4].

Financial Trajectory

Revenue Forecast

The global amlexanox market is projected to grow substantially, with revenue forecasted in USD millions. The market size and predictions indicate a steady increase over the forecast period, driven by the growing demand for the drug[1][4].

Historical Performance

Historical data from 2021 to 2023 shows a steady growth trend, with the market responding positively to the effectiveness of amlexanox in treating aphthous ulcers. This trend is expected to continue into the forecast period[1].

Competitive Landscape

The competitive landscape is characterized by the presence of a few key players who dominate the market. These companies invest heavily in research and development to maintain their market position and explore new applications for amlexanox[1][4].

Clinical Efficacy and Safety

Clinical Studies

Clinical studies have demonstrated the efficacy of amlexanox in treating aphthous ulcers. For instance, a study involving 464 patients showed that amlexanox oral paste significantly accelerated healing and reduced pain compared to placebo and no treatment groups[5].

Safety Profile

Amlexanox has a favorable safety profile, with no significant topical or systemic adverse effects observed in clinical studies. However, it is contraindicated in patients with known hypersensitivity to the drug[5].

Regional Analysis

North America

North America is a significant market for amlexanox due to high healthcare spending and a large patient population suffering from aphthous ulcers.

Europe

Europe also represents a substantial market, driven by advanced healthcare systems and a high demand for effective treatments.

Asia-Pacific

The Asia-Pacific region is expected to show rapid growth due to increasing healthcare expenditure and a large patient base[1][4].

Future Projections

The future of the amlexanox market looks promising, driven by increasing demand and expanding into new markets. Here are some key projections:

  • Market Growth: The market is expected to grow at a good pace, with significant revenue increases forecasted.
  • New Applications: Research into new applications could further expand the market share of amlexanox.
  • Geographical Expansion: Emerging markets are expected to contribute significantly to the growth of the amlexanox market[1][4].

Key Takeaways

  • The global amlexanox market is expected to grow significantly over the forecast period.
  • The market is segmented by application, product, and geography.
  • Key players include Amlexanox, Uluru Inc, Chemex Pharmaceuticals, and Block Drug.
  • Clinical studies have shown the efficacy and safety of amlexanox in treating aphthous ulcers.
  • The market is driven by increasing demand and has potential for growth in new markets.

FAQs

What is the primary application of amlexanox?

Amlexanox is primarily used for the treatment of recurrent aphthous ulcers (canker sores).

Which companies are the key players in the amlexanox market?

The key players include Amlexanox, Uluru Inc, Chemex Pharmaceuticals, and Block Drug.

What is the expected growth of the amlexanox market?

The market is expected to grow significantly over the forecast period of 2024-2031, driven by increasing demand and expanding into new markets.

What are the contraindications for amlexanox?

Amlexanox is contraindicated in patients with known hypersensitivity to the drug.

How does amlexanox work in treating aphthous ulcers?

Amlexanox accelerates the healing of aphthous ulcers and reduces pain, as demonstrated in clinical studies.

Sources

  1. Market Research Intellect: Amlexanox Market Size, Share, Outlook, Analysis and Forecast.
  2. PLOS ONE: Anti-Allergic Cromones Inhibit Histamine and Eicosanoid Release.
  3. MDPI: Drug Repurposing for Amyotrophic Lateral Sclerosis Based on Gene Expression Analysis and Structural Similarity Approaches.
  4. Valuates Reports: Global Amlexanox Market Research Report.
  5. FDA: Aphthasol (amlexanox oral paste) Label.

More… ↓

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