Methacholine chloride - Generic Drug Details

What are the generic drug sources for methacholine chloride and what is the scope of freedom to operate?

Methacholine chloride is the generic ingredient in one branded drug marketed by Methapharm and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for methacholine chloride. One supplier is listed for this compound.

Summary for methacholine chloride

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	12
Patent Applications:	5,922
What excipients (inactive ingredients) are in methacholine chloride?	methacholine chloride excipients list
DailyMed Link:	methacholine chloride at DailyMed

Recent Clinical Trials for methacholine chloride

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

Sponsor	Phase
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	N/A
Aurobindo Pharma Ltd	Phase 3
University of Saskatchewan	Phase 4

See all methacholine chloride clinical trials

Pharmacology for methacholine chloride

Drug Class	Cholinergic Receptor Agonist
Mechanism of Action	Cholinergic Agonists

Medical Subject Heading (MeSH) Categories for methacholine chloride

Bronchoconstrictor Agents

Miotics

Muscarinic Agonists

Parasympathomimetics

Anatomical Therapeutic Chemical (ATC) Classes for methacholine chloride

V04CX	Other diagnostic agents
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for methacholine chloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Methapharm	PROVOCHOLINE	methacholine chloride	FOR SOLUTION;INHALATION	019193-002	Aug 29, 2016		DISCN	Yes	No
Methapharm	PROVOCHOLINE	methacholine chloride	FOR SOLUTION;INHALATION	019193-001	Oct 31, 1986		RX	Yes	Yes

Methacholine chloride Market Analysis and Financial Projection Experimental

Methacholine Chloride Market Dynamics and Financial Trajectory

Introduction to Methacholine Chloride

Methacholine chloride, also known as Provocholine, is a bronchoconstrictor agent used primarily for the diagnosis of bronchial airway hyperreactivity. It is particularly useful in subjects who do not have clinically apparent asthma[2][4].

Market Overview

The market for methacholine chloride is niche but critical within the healthcare sector, particularly in respiratory diagnostics.

Clinical Use and Applications

Methacholine chloride is indicated for diagnostic purposes only and is not used as a therapeutic agent. It is administered as an inhalation solution to stimulate bronchial smooth muscle, helping in the diagnosis of airway hyperreactivity. The drug is the ß-methyl homolog of acetylcholine and has a greater duration and selectivity of action compared to acetylcholine[4].

Market Drivers

Increasing Demand in Respiratory Diagnostics

The growing need for accurate diagnostic tools in respiratory medicine is driving the demand for methacholine chloride. As respiratory diseases such as asthma and COPD continue to rise, the importance of precise diagnostic methods increases, thereby boosting the market for this drug[2].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in developing countries, are leading to better access to diagnostic services. This expansion is expected to increase the usage of methacholine chloride in various medical settings.

Market Challenges

Regulatory and Safety Concerns

Methacholine chloride, like other pharmaceuticals, is subject to strict regulatory oversight. The drug can cause serious toxic reactions, including syncopal reactions, cardiac arrest, and loss of consciousness. These risks necessitate careful handling and administration, which can sometimes limit its use[4].

Alternative Diagnostic Methods

The development of alternative diagnostic methods and tools could potentially reduce the reliance on methacholine chloride. However, its specific use in diagnosing bronchial airway hyperreactivity makes it a unique and essential tool in respiratory medicine.

Financial Trajectory

Reimbursement and Billing Guidelines

In the United States, methacholine chloride is covered by Medicaid and NC Health Choice programs when billed with the HCPCS code J7674. The maximum reimbursement rate per unit is $0.52, and providers must follow specific billing guidelines, including the use of National Drug Codes (NDCs)[2].

Market Size and Growth

While specific financial data on the methacholine chloride market is limited due to its niche nature, the overall demand driven by increasing diagnostic needs suggests a stable, if not growing, market. The healthcare sector's expansion and the rising incidence of respiratory diseases are key factors supporting this growth.

Geographical Distribution

The market for methacholine chloride is global, but its usage is more prevalent in regions with advanced healthcare systems. In the United States, for example, the drug is widely used in respiratory diagnostic procedures.

Competitive Landscape

The competitive landscape for methacholine chloride is relatively stable, with a few key players dominating the market. The drug's specific use and regulatory requirements limit the number of manufacturers and distributors.

Key Statistics

• Billing and Reimbursement: Methacholine chloride is billed with HCPCS code J7674, with a maximum reimbursement rate of $0.52 per unit[2].
• Clinical Use: The drug is used in diagnostic procedures for bronchial airway hyperreactivity, with two different dosing protocols available[2][4].

Future Outlook

The future outlook for the methacholine chloride market is positive, driven by the increasing need for accurate respiratory diagnostics. Here are some key points to consider:

Growing Healthcare Needs

As the global population ages and the incidence of respiratory diseases increases, the demand for diagnostic tools like methacholine chloride is expected to rise.

Technological Advancements

Advancements in medical technology and diagnostic methods may enhance the use and efficacy of methacholine chloride, further solidifying its place in respiratory medicine.

Key Takeaways

• Diagnostic Importance: Methacholine chloride is a critical diagnostic tool for bronchial airway hyperreactivity.
• Regulatory Oversight: The drug is subject to strict regulatory guidelines due to its potential for serious toxic reactions.
• Financial Stability: The market is financially stable, with reimbursement rates and billing guidelines well-defined.
• Future Growth: The market is expected to grow due to increasing healthcare needs and advancements in diagnostic technologies.

Frequently Asked Questions (FAQs)

1. What is methacholine chloride used for? Methacholine chloride is used for the diagnosis of bronchial airway hyperreactivity in subjects who do not have clinically apparent asthma.

2. How is methacholine chloride administered? It is administered as an inhalation solution using a nebulizer, with two different dosing protocols available.

3. What are the potential risks associated with methacholine chloride? The drug can cause serious toxic reactions, including syncopal reactions, cardiac arrest, and loss of consciousness.

4. Is methacholine chloride covered by Medicaid? Yes, methacholine chloride is covered by Medicaid and NC Health Choice programs when billed with the appropriate HCPCS code.

5. What is the reimbursement rate for methacholine chloride? The maximum reimbursement rate per unit is $0.52.

Cited Sources:

1. Methallyl chloride Market Revenue, Major Players, Consumer Trends Analysis, Forecast till 2030 - IndustryARC[1]
2. Billing Guidelines: Methacholine chloride (Provocholine), HCPCS Code J7674 - CSRA[2]
3. Methallyl Chloride Market Report, 2022-2027 - IndustryARC[3]
4. PROVOCHOLINE - (methacholine chloride USP) powder for solution - FDA[4]