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Last Updated: December 23, 2024

PROVOCHOLINE Drug Patent Profile


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

Provocholine is a drug marketed by Methapharm and is included in one NDA.

The generic ingredient in PROVOCHOLINE is methacholine chloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methacholine chloride profile page.

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Summary for PROVOCHOLINE
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Recent Clinical Trials for PROVOCHOLINE

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

SponsorPhase
Dr. Diane LougheedPhase 4
Queen's UniversityPhase 4
University of SaskatchewanPhase 3

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Pharmacology for PROVOCHOLINE
Drug ClassCholinergic Receptor Agonist
Mechanism of ActionCholinergic Agonists

US Patents and Regulatory Information for PROVOCHOLINE

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 019193-001 Oct 31, 1986 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Methapharm PROVOCHOLINE methacholine chloride FOR SOLUTION;INHALATION 019193-002 Aug 29, 2016 DISCN 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

PROVOCHOLINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Provocholine

Introduction

Provocholine, also known as methacholine chloride, is a crucial diagnostic tool in the field of respiratory medicine, particularly for detecting bronchial airway hyperreactivity and assisting in the diagnosis of asthma. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Need and Demand

Asthma is a significant health concern, with approximately 5.4 million people in the UK alone receiving treatment for the condition, resulting in annual costs of over £1 billion for treatment and care[1].

  • The high prevalence of asthma and the need for accurate diagnosis drive the demand for diagnostic tools like Provocholine.
  • Misdiagnosis is a common issue, with about one-third of asthma patients reported to have been misdiagnosed. Provocholine can help eliminate such misdiagnoses through direct challenge testing[1].

Regulatory and Market Approval

Provocholine is the only FDA-approved methacholine chloride powder for use in humans, highlighting its unique position in the market[4].

  • The drug is used by healthcare specialists in patients aged 17 and over to detect bronchial airway hyperreactivity, making it a vital tool in respiratory diagnostics[1].

Distribution and Partnerships

Galen, a global pharmaceutical company, has acquired the rights to distribute and commercialize Provocholine in the UK. This partnership extends Galen’s product portfolio into the respiratory disease market[1].

  • Another significant partnership involves Nephron Pharmaceuticals Corporation, which collaborates with Methapharm to produce kits of methacholine chloride sterile inhalation solution. This collaboration enhances the availability and reliability of Provocholine for bronchoprovocation challenge testing[4].

Financial Impact

The financial trajectory of Provocholine is closely tied to its distribution and usage.

  • Revenue Generation: The drug contributes to the revenue streams of companies like Galen and Methapharm. Given the high demand for accurate asthma diagnosis, Provocholine is likely to generate significant revenue, especially in regions where it is exclusively distributed[1].
  • Cost Savings: By reducing misdiagnoses, Provocholine can help in cost savings for healthcare systems. Accurate diagnoses can lead to more targeted treatments, reducing the overall cost of asthma care[1].

Competitive Landscape

The market for respiratory diagnostic tools is competitive, but Provocholine holds a unique position due to its FDA approval and specific use case.

  • Competition: While there are other diagnostic methods, Provocholine’s approval and widespread use give it a competitive edge. However, other companies may develop alternative diagnostic tools, posing potential competition in the future[4].

Clinical and Operational Efficiency

The efficiency of Provocholine in clinical settings is crucial for its market success.

  • Nebulizer Characterization: Methapharm has conducted comprehensive nebulizer characterization studies to support the clinical use of Provocholine, ensuring its reliability and effectiveness in bronchoprovocation testing[4].
  • Stable Room Temperature Solution: The collaboration with Nephron ensures that Provocholine is available in stable room temperature solution kits, making it easier for testing facilities to use[4].

Future Growth Prospects

The future growth of Provocholine is promising due to several factors:

  • Expanding Distribution: Partnerships like the one between Galen and Methapharm are expected to expand the availability of Provocholine in new markets, including the UK and other regions[1].
  • Clinical Standards: Continuous support for clinical standards, such as the recommendation of PD20 as a clinical endpoint, enhances the drug’s credibility and usage[4].

Challenges and Opportunities

While Provocholine has a strong market position, there are challenges and opportunities to consider:

  • Challenges: The success of Provocholine depends on maintaining high-quality manufacturing and supply chain efficiency. Regulatory changes and the development of alternative diagnostic tools could also pose challenges[4].
  • Opportunities: Expanding into new markets and enhancing clinical standards can drive further growth. Collaborations with other pharmaceutical companies could also accelerate development and expand market reach[1].

Key Takeaways

  • Provocholine is a critical diagnostic tool for asthma and respiratory diseases.
  • It has a strong market position due to its FDA approval and exclusive distribution agreements.
  • The drug contributes significantly to the revenue of companies like Galen and Methapharm.
  • Future growth prospects are promising, driven by expanding distribution and adherence to clinical standards.

FAQs

What is Provocholine used for?

Provocholine, or methacholine chloride, is used to detect bronchial airway hyperreactivity and assist in the diagnosis of asthma in patients aged 17 and over[1].

Who distributes Provocholine in the UK?

Galen, a global pharmaceutical company, has acquired the rights to exclusively distribute and commercialize Provocholine in the UK[1].

What is the significance of the Nephron-Methapharm collaboration?

The collaboration between Nephron Pharmaceuticals Corporation and Methapharm ensures the production of stable room temperature solution kits of methacholine chloride, enhancing the reliability and availability of Provocholine for bronchoprovocation challenge testing[4].

How does Provocholine impact healthcare costs?

By reducing misdiagnoses, Provocholine can help in cost savings for healthcare systems by leading to more targeted and effective treatments for asthma[1].

What are the future growth prospects for Provocholine?

The future growth of Provocholine is expected to be driven by expanding distribution agreements, adherence to clinical standards, and potential collaborations with other pharmaceutical companies[1][4].

References

  1. Galen expands product portfolio with Provocholine® (methacholine chloride) - Almac Group, April 11, 2022.
  2. KMDA Stock Price & AI BUY/SELL Advice - Upturn Advisories.
  3. Mathematical Modeling of the Drug Particles Deposition in the Organs of the Human Respiratory System - MDPI.
  4. New Nephron-Methapharm Collaboration Improves Health Outcomes for Respiratory Patients - Biospace, July 6, 2020.

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