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Last Updated: December 22, 2024

REGONOL Drug Patent Profile


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Which patents cover Regonol, and when can generic versions of Regonol launch?

Regonol is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in REGONOL is pyridostigmine bromide. There are eleven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Regonol

A generic version of REGONOL was approved as pyridostigmine bromide by IMPAX LABS on April 24th, 2003.

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Summary for REGONOL
Drug patent expirations by year for REGONOL
Drug Prices for REGONOL

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Recent Clinical Trials for REGONOL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institutes of Health (NIH)Early Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Early Phase 1
Icahn School of Medicine at Mount SinaiEarly Phase 1

See all REGONOL clinical trials

Pharmacology for REGONOL

US Patents and Regulatory Information for REGONOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz REGONOL pyridostigmine bromide INJECTABLE;INJECTION 017398-001 Approved Prior to Jan 1, 1982 AP RX 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

REGONOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Extended-Release Drugs: A Case Study on REGONOL

Introduction

Extended-release drugs, such as REGONOL, are transforming the pharmaceutical landscape by offering improved patient compliance, enhanced efficacy, and better management of chronic diseases. This article delves into the market dynamics and financial trajectory of extended-release drugs, using REGONOL as a case study.

Market Overview of Extended-Release Drugs

The global extended-release drugs market has been experiencing rapid growth. In 2023, the market size was valued at $57.11 billion and is projected to reach $63.82 billion in 2024, with a compound annual growth rate (CAGR) of 11.7%[1].

Types of Extended-Release Drugs

Extended-release drugs can be categorized into two main types:

  • Sustained Release Drugs: These drugs release the active ingredient at a predetermined rate to maintain a constant drug concentration over a specific period.
  • Controlled Release Drugs: These drugs release the active ingredient in a controlled manner, often using advanced drug delivery systems[1].

Distribution Channels

The distribution of extended-release drugs occurs through various channels, including:

  • Hospital Pharmacies
  • Retail Pharmacies
  • Mail Order Pharmacies
  • Drug Stores[1].

Market Growth Drivers

Several factors are driving the growth of the extended-release drugs market:

  • Improved Patient Compliance: Extended-release formulations reduce the frequency of dosing, enhancing patient adherence.
  • Chronic Disease Prevalence: The increasing incidence of chronic diseases necessitates more effective and convenient treatment options.
  • Personalized Medicine: Advances in personalized medicine are leading to more targeted and effective drug therapies.
  • Pharmaceutical Innovation: Innovations in drug delivery systems, nanotechnology, and 3D printing are expanding the capabilities of extended-release drugs[1].

Financial Trajectory

The financial trajectory of the extended-release drugs market is robust. Here are some key financial projections:

  • Market Size by 2028: The market is expected to grow to $99.77 billion by 2028, with a CAGR of 11.8%[1].
  • Revenue Growth: The rapid growth is attributed to factors such as drug repurposing, global access to extended-release therapies, and advancements in drug delivery systems.

Case Study: REGONOL

REGONOL, an extended-release formulation, benefits from the overall market trends. Here’s how it fits into the broader market dynamics:

Patient Compliance

REGONOL, like other extended-release drugs, improves patient compliance by reducing the number of doses required. This is particularly beneficial for patients with chronic conditions who may find it challenging to adhere to multiple daily doses.

Chronic Disease Management

Given the rising prevalence of chronic diseases, REGONOL and similar drugs are in high demand. These drugs offer sustained therapeutic effects, which are crucial for managing conditions such as diabetes, hypertension, and asthma.

Pharmaceutical Innovation

The development of REGONOL likely involves advanced drug delivery systems, which are a key trend in the extended-release drugs market. Innovations such as nanotechnology and 3D printing can enhance the efficacy and stability of the drug.

Market Trends and Innovations

Several trends and innovations are shaping the future of extended-release drugs like REGONOL:

Drug Repurposing

Drug repurposing, or finding new uses for existing drugs, is a significant trend. This approach can reduce development costs and time, making it a viable strategy for companies developing extended-release formulations[3].

Advanced Drug Delivery Systems

The use of advanced drug delivery systems, such as injectable formulations and biodegradable implants, is on the rise. These systems enhance the delivery and efficacy of extended-release drugs[4].

Nanotechnology and 3D Printing

Nanotechnology and 3D printing are emerging as key technologies in the development of extended-release drugs. These technologies allow for more precise and controlled drug release, improving the therapeutic outcomes[1].

Regional Analysis

The global extended-release drugs market, including REGONOL, exhibits geographical fragmentation:

  • North America: Dominates the market with a significant share, driven by heightened research and development activities and strong healthcare infrastructure[3][4].

Competitive Landscape

The market for extended-release drugs is competitive, with several major players:

  • BD
  • Baxter International Inc.
  • Gerresheimer AG
  • West Pharmaceutical Services Inc.[4].

Financial Sustainability and Policy Implications

While the extended-release drugs market is financially robust, broader fiscal policies can impact its growth. For instance, unsustainable fiscal paths, as highlighted in the Financial Report of the United States Government, could affect healthcare spending and thus the market for extended-release drugs[2].

Key Takeaways

  • The extended-release drugs market, including REGONOL, is growing rapidly due to improved patient compliance, chronic disease prevalence, and pharmaceutical innovation.
  • The market is expected to reach $99.77 billion by 2028 with a CAGR of 11.8%.
  • Advanced drug delivery systems, nanotechnology, and 3D printing are key trends driving the market.
  • Regional growth is led by North America, with significant contributions from research and development activities.
  • The competitive landscape includes major players investing in product development and geographical expansion.

FAQs

What are the main types of extended-release drugs?

Extended-release drugs can be categorized into sustained release drugs and controlled release drugs, each with different mechanisms for releasing the active ingredient[1].

How does the extended-release drugs market benefit from drug repurposing?

Drug repurposing reduces development costs and time, making it a cost-effective and time-efficient alternative to developing new drugs. This approach can significantly contribute to the growth of the extended-release drugs market[3].

What are the key drivers of the extended-release drugs market?

Key drivers include improved patient compliance, chronic disease prevalence, personalized medicine approaches, and advancements in drug delivery systems[1].

Which region dominates the extended-release drugs market?

North America dominates the market, driven by strong research and development activities and a robust healthcare infrastructure[3][4].

How do advanced technologies like nanotechnology and 3D printing impact extended-release drugs?

These technologies enable more precise and controlled drug release, improving therapeutic outcomes and enhancing the efficacy and stability of extended-release drugs[1].

Sources

  1. The Business Research Company: Global Extended Release Drugs Market Report 2024
  2. Financial Report of the United States Government: Unsustainable Fiscal Path
  3. Market.us: Drug Repurposing Market Outlook, Assessment
  4. Fortune Business Insights: Drug Delivery Systems Market Size, Share | Global Report [2032]

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