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Last Updated: December 22, 2024

ROBINUL Drug Patent Profile


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

Robinul is a drug marketed by Hikma, Robins Ah, and Casper Pharma Llc. and is included in three NDAs.

The generic ingredient in ROBINUL is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Robinul

A generic version of ROBINUL was approved as glycopyrrolate by AM REGENT on July 23rd, 1986.

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

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Recent Clinical Trials for ROBINUL

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SponsorPhase
McGill University Health Centre/Research Institute of the McGill University Health CentreN/A
McGill University Health CenterN/A
University of OuluPhase 4

See all ROBINUL clinical trials

US Patents and Regulatory Information for ROBINUL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma ROBINUL glycopyrrolate INJECTABLE;INJECTION 017558-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Casper Pharma Llc ROBINUL FORTE glycopyrrolate TABLET;ORAL 012827-002 Approved Prior to Jan 1, 1982 AA RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Robins Ah ROBINUL glycopyrrolate INJECTABLE;INJECTION 014764-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Casper Pharma Llc ROBINUL glycopyrrolate TABLET;ORAL 012827-001 Approved Prior to Jan 1, 1982 AA RX Yes 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

ROBINUL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Glycopyrrolate (ROBINUL)

Introduction

Glycopyrrolate, commonly known by the brand name ROBINUL, is an anticholinergic medication used to treat various medical conditions, including reducing saliva production, treating bradycardia, and managing gastrointestinal disorders. Here, we will delve into the market dynamics and financial trajectory of glycopyrrolate, highlighting key factors influencing its growth and future projections.

Market Size and Growth Projections

The glycopyrrolate market is anticipated to experience significant growth over the forecast period from 2024 to 2031. The market size is expected to expand at a remarkable Compound Annual Growth Rate (CAGR), driven by increasing demand for effective treatments for conditions such as gastrointestinal disorders and the need for preoperative medications[1][4].

Market Segmentation

The glycopyrrolate market is segmented based on several key factors:

By Type

  • Glycopyrrolate Tablet: This form is commonly used for oral administration and is preferred for long-term treatment.
  • Glycopyrrolate Solution: This form is often used for intravenous or intramuscular administration, particularly in acute settings[1][4].

By Application

  • Hospitals: Glycopyrrolate is widely used in hospital settings for preoperative and postoperative care.
  • Clinics: It is also used in clinical settings for treating various anticholinergic indications.
  • Other: This includes palliative care, hospice care, and other medical facilities[1][4].

By Geography

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

Drivers of Market Growth

Several factors are driving the growth of the glycopyrrolate market:

Increasing Incidence of Disorders

The rising incidence of gastrointestinal disorders and other conditions that require anticholinergic treatment is a significant driver. As the global population ages, the demand for effective medications like glycopyrrolate is expected to increase[4].

Advances in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in developing regions, are enhancing access to medications like glycopyrrolate. This expansion in healthcare services is driving up demand for the drug[4].

Regulatory Support

Government policies and regulatory frameworks that support the development and distribution of pharmaceuticals are also contributing to the market's growth. Favorable regulations can reduce barriers to entry and encourage innovation[4].

Restraints and Challenges

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

Side Effects and Safety Concerns

Glycopyrrolate, like other anticholinergic drugs, has been associated with potential side effects and long-term risks, such as an increased risk of dementia. This has led to cautious prescribing practices and may impact market growth[2].

Competition from Alternatives

The presence of alternative medications and treatments can pose a threat to the market. As new drugs and therapies are developed, they may capture market share from existing treatments like glycopyrrolate[4].

Economic Factors

The high costs associated with research and development, as well as the pricing strategies of pharmaceutical companies, can affect the market's financial trajectory. High prices may limit access to the drug, especially in regions with limited healthcare budgets[3].

Financial Trajectory

The financial performance of the glycopyrrolate market is expected to be robust, driven by the factors mentioned above.

Revenue Projections

The market is projected to generate significant revenue over the forecast period, with estimates suggesting exponential growth. The revenue is measured in USD million and is expected to increase substantially from 2024 to 2031[1].

Market Concentration and Competition

The market is characterized by a moderate level of competition, with several key players such as Toobapharma, Infa Group, and Suven Life Sciences Limited. The market concentration ratio and other competitive metrics indicate a balanced market where no single player dominates entirely[1][4].

Pricing Strategies

Pricing strategies play a crucial role in the financial trajectory of the glycopyrrolate market. Companies must balance the need for profitability with the need to keep prices accessible to a wide range of patients. The pricing of glycopyrrolate is influenced by factors such as production costs, regulatory environments, and competitive pressures[3].

Macro-Economic Factors

Macro-economic factors also influence the glycopyrrolate market:

Government Policies and Regulations

Government policies, such as those related to healthcare access and pharmaceutical pricing, can significantly impact the market. Regulatory changes can either facilitate or hinder market growth[4].

Economic Conditions

Global economic conditions, including GDP growth rates and healthcare spending, can affect the demand for glycopyrrolate. Economic downturns may reduce healthcare spending, while economic growth can increase it[4].

Value Chain Analysis

The value chain analysis of the glycopyrrolate market includes several key stages:

Manufacturing Process

The manufacturing process involves the synthesis of the active ingredient and the formulation of the final product. Companies must ensure compliance with regulatory standards to maintain product quality[4].

Distribution Channels

Effective distribution channels are crucial for ensuring that glycopyrrolate reaches the end-users efficiently. This includes partnerships with pharmacies, hospitals, and other healthcare providers[4].

Cost Analysis

The cost analysis involves evaluating the costs associated with research and development, manufacturing, marketing, and distribution. Companies must manage these costs to maintain profitability while keeping prices competitive[4].

Company Profiles

Key companies in the glycopyrrolate market include:

Toobapharma

Toobapharma is one of the leading manufacturers of glycopyrrolate, known for its high-quality products and extensive distribution network.

Infa Group

Infa Group is another significant player, focusing on innovative formulations and strong market presence.

Suven Life Sciences Limited

Suven Life Sciences Limited is a prominent player in the pharmaceutical industry, with a strong portfolio of anticholinergic drugs including glycopyrrolate[1].

Roadmap of Glycopyrrolate Market

The roadmap for the glycopyrrolate market involves several strategic steps:

Market Entry Strategies

New entrants into the market must develop effective market entry strategies, including partnerships, licensing agreements, and innovative marketing approaches[4].

Innovation and R&D

Continuous innovation and investment in research and development are essential for maintaining market competitiveness. This includes developing new formulations and improving existing products[3].

Regulatory Compliance

Ensuring regulatory compliance is critical for market success. Companies must adhere to strict guidelines and standards set by regulatory bodies to avoid legal and financial repercussions[4].

Impact of Macro-Economic Factors

Macro-economic factors such as economic growth rates, government policies, and global health trends significantly impact the glycopyrrolate market.

Economic Growth

Economic growth can increase healthcare spending, thereby boosting demand for glycopyrrolate. Conversely, economic downturns can reduce demand[4].

Government Policies

Government policies related to healthcare access, pricing, and regulation can either support or hinder market growth. Favorable policies can create a conducive environment for the market to thrive[4].

Key Takeaways

  • The glycopyrrolate market is expected to grow significantly over the forecast period driven by increasing demand and favorable market dynamics.
  • The market is segmented by type, application, and geography, each with its own growth drivers and restraints.
  • Key drivers include the rising incidence of disorders, advances in healthcare infrastructure, and regulatory support.
  • Challenges such as side effects, competition from alternatives, and economic factors need to be addressed.
  • The financial trajectory is robust, with significant revenue projections and a balanced competitive landscape.

FAQs

What are the primary types of glycopyrrolate available in the market?

The primary types of glycopyrrolate available are glycopyrrolate tablets and glycopyrrolate solutions[1][4].

Which regions are expected to drive the growth of the glycopyrrolate market?

North America, Europe, and the Asia-Pacific regions are expected to be significant drivers of market growth due to their large patient populations and advanced healthcare infrastructures[1][4].

What are the major side effects associated with glycopyrrolate?

Glycopyrrolate, like other anticholinergic drugs, has been associated with potential side effects such as dry mouth, constipation, and an increased risk of dementia[2].

How does the competitive landscape of the glycopyrrolate market look?

The market is characterized by a moderate level of competition with several key players. The market concentration ratio indicates a balanced market where no single player dominates entirely[1][4].

What role do government policies play in the glycopyrrolate market?

Government policies related to healthcare access, pricing, and regulation play a crucial role in shaping the market. Favorable policies can create a conducive environment for market growth[4].

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