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Last Updated: December 22, 2024

MUCOSIL-20 Drug Patent Profile


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Which patents cover Mucosil-20, and when can generic versions of Mucosil-20 launch?

Mucosil-20 is a drug marketed by DEY and is included in one NDA.

The generic ingredient in MUCOSIL-20 is acetylcysteine. There are three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mucosil-20

A generic version of MUCOSIL-20 was approved as acetylcysteine by HOSPIRA on August 30th, 1994.

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Summary for MUCOSIL-20
Drug patent expirations by year for MUCOSIL-20

US Patents and Regulatory Information for MUCOSIL-20

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dey MUCOSIL-20 acetylcysteine SOLUTION;INHALATION, ORAL 070576-001 Oct 14, 1986 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

MUCOSIL-20 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oral Transmucosal Drugs: A Case Study of MUCOSIL-20

Introduction to Oral Transmucosal Drugs

Oral transmucosal drugs are designed to be delivered through the mucous membranes in the mouth, bypassing the digestive system and first-pass metabolism, which can significantly enhance the bioavailability and onset of action of the drug.

Market Overview of Oral Transmucosal Drugs

The oral transmucosal drugs market was valued at over $14 billion in 2020 and is projected to expand at a CAGR of approximately 6% from 2021 to 2031. This growth is driven by several key factors, including the rise in prevalence of neurological disorders and chronic diseases, an increase in the geriatric population, and the adoption of novel drug delivery systems[1].

Key Drivers of the Market

Rise in Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases such as cardiovascular disorders, diabetes, and neurological conditions is a significant driver for the oral transmucosal drugs market. These conditions often require rapid and effective symptom management, which oral transmucosal drugs can provide.

Growing Geriatric Population

The geriatric population is more prone to chronic diseases and often has difficulty swallowing traditional oral medications. Oral transmucosal drugs offer a convenient and effective alternative, contributing to the market's growth.

Adoption of Novel Drug Delivery Systems

Advancements in mucoadhesive polymers and other technologies have improved the efficacy and comfort of oral transmucosal drug delivery systems. Companies like Aquestive Therapeutics are focusing on developing novel permeation enhancers, stabilizers, and polymer blends to enhance drug penetration through the mucosa[1].

Market Segmentation and Distribution

Route of Penetration

The market is segmented by the route of penetration, with the buccal mucosa segment holding a major share. Other routes include sublingual mucosa, gingival tissues, and palatal tissues[1].

Distribution Channels

Oral transmucosal drugs are distributed through hospital pharmacies, retail pharmacies, and online pharmacies. The convenience and accessibility of these channels contribute to the market's expansion[1].

Indications

These drugs are used for various indications, including cardiovascular disorders, acute pain management, sedation, erectile dysfunction, and diabetes. The versatility in application further boosts market growth[1].

Financial Trajectory

Market Value Forecast

The oral transmucosal drugs market is expected to reach $27 billion by 2031, driven by the factors mentioned above. The CAGR of 6% indicates a steady and significant growth trajectory over the forecast period[1].

Regional Analysis

The market is analyzed across various regions, including the U.S., Canada, Europe, Asia Pacific, and Latin America. The U.S. is expected to dominate the market due to its large patient population and advanced healthcare infrastructure[1].

Case Study: MUCOSIL-20

Product Overview

MUCOSIL-20, assuming it is a product within the oral transmucosal drugs market, would likely benefit from the overall market trends. Here’s how it might fit into the broader market dynamics:

Market Positioning

If MUCOSIL-20 is designed for rapid onset of action and improved bioavailability, it would align well with the market's demand for effective and convenient drug delivery systems. Its positioning could be strengthened by targeting specific indications where rapid symptom relief is crucial, such as acute pain management or neurological disorders.

Competitive Landscape

The competitive landscape includes key players like LTS Lohmann Therapie-Systeme AG, Soligenix, ZIM Laboratories Limited, and Aquestive Therapeutics. MUCOSIL-20 would need to differentiate itself through innovative formulations, enhanced efficacy, or better patient compliance to compete effectively in this market[1].

Financial Projections

Given the market's projected CAGR of 6%, MUCOSIL-20 could expect significant revenue growth if it captures a substantial market share. The product's financial trajectory would be influenced by its adoption rate, pricing strategy, and the extent to which it addresses unmet needs in the market.

Challenges and Opportunities

Challenges

Despite the advantages, there are challenges such as the relatively low penetration of buccal or sublingual formulations and the need for continuous R&D to improve drug delivery systems. Additionally, regulatory and reimbursement hurdles can affect market growth[1].

Opportunities

The increasing focus on palliative and end-of-life care, especially during health crises like the coronavirus outbreak, presents opportunities for oral transmucosal drugs. Companies can capitalize on these needs by developing drugs that provide fast and effective symptom relief[1].

Key Takeaways

  • Market Growth: The oral transmucosal drugs market is expected to grow at a CAGR of 6% from 2021 to 2031.
  • Key Drivers: Rise in chronic diseases, growing geriatric population, and adoption of novel drug delivery systems.
  • Market Segmentation: Segmented by route of penetration, distribution channels, and indications.
  • Financial Trajectory: Expected to reach $27 billion by 2031.
  • Competitive Landscape: Includes key players like LTS Lohmann Therapie-Systeme AG and Aquestive Therapeutics.

FAQs

What is the projected CAGR for the oral transmucosal drugs market from 2021 to 2031?

The oral transmucosal drugs market is projected to expand at a CAGR of approximately 6% from 2021 to 2031[1].

Which segment holds the major share in the oral transmucosal drugs market?

The buccal mucosa segment holds a major share in the global oral transmucosal drugs market[1].

What are the key drivers of the oral transmucosal drugs market?

The key drivers include the rise in prevalence of neurological disorders and chronic diseases, an increase in the geriatric population, and the adoption of novel drug delivery systems[1].

Which companies are key players in the oral transmucosal drugs market?

Key players include LTS Lohmann Therapie-Systeme AG, Soligenix, ZIM Laboratories Limited, Access Pharmaceutical Inc., and Aquestive Therapeutics[1].

What is the expected market value of oral transmucosal drugs by 2031?

The oral transmucosal drugs market is expected to reach $27 billion by 2031[1].

Sources

  1. Transparency Market Research, "Oral Transmucosal Drugs Market Insight and Trends 2026"[1].
  2. ASPR, "ASPR-cj.pdf - HHS.gov"[2].
  3. GlobalData, "Cystic Fibrosis - Global Drug Forecast and Market Analysis to 2030"[3].
  4. ASPE, "Competition in Prescription Drug Markets, 2017-2022"[4].

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