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Last Updated: December 22, 2024

METHDILAZINE - Generic Drug Details


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What are the generic drug sources for methdilazine and what is the scope of patent protection?

Methdilazine is the generic ingredient in two branded drugs marketed by Westwood Squibb and Alpharma Us Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for methdilazine.

Summary for METHDILAZINE

US Patents and Regulatory Information for METHDILAZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Westwood Squibb TACARYL methdilazine hydrochloride TABLET;ORAL 011950-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Westwood Squibb TACARYL methdilazine TABLET, CHEWABLE;ORAL 011950-009 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Westwood Squibb TACARYL methdilazine hydrochloride SYRUP;ORAL 011950-007 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alpharma Us Pharms METHDILAZINE HYDROCHLORIDE methdilazine hydrochloride SYRUP;ORAL 087122-001 Approved Prior to Jan 1, 1982 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

METHDILAZINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Methdilazine

Introduction

Methdilazine, a pharmaceutical compound with the CAS number 1982-37-2, is used in various medical applications, primarily as an antihistamine. Understanding the market dynamics and financial trajectory of methdilazine involves analyzing its production, distribution, pricing, and the overall market trends.

Market Situation and Trends

The global market for methdilazine is influenced by several key factors:

Manufacturers and Suppliers

Methdilazine is manufactured and supplied by companies across different regions, including Europe, Asia, and North America. The report by Research and Markets highlights that identifying major players in the industry is crucial for understanding the market dynamics. These manufacturers and suppliers play a significant role in determining the availability and pricing of methdilazine[3].

End-Use Sectors

Methdilazine is used in various end-use sectors, primarily in the pharmaceutical industry for its antihistamine properties. The demand from these sectors drives the production and supply of methdilazine. The report breaks down the end-use sectors to provide a clear view of the market's demand side[3].

Market Size and Growth

The market size of methdilazine can be estimated by looking at the overall sales revenues and volume of antihistamine drugs.

Sales Revenues and Volume

While specific data on methdilazine's sales revenues and volume is not readily available, the broader pharmaceutical market trends can provide insights. For instance, the sales revenues of prescription drugs, including antihistamines, have shown significant growth. In the U.S., prescription drug sales revenues grew from $582 billion in 2017 to $716 billion in 2022, a 23% increase[2].

Regional Market Analysis

The market for methdilazine varies by region. In Europe, Asia, and North America, different manufacturers and suppliers dominate the market. The regional market analysis helps in understanding the pricing strategies, distribution channels, and regulatory environments that affect methdilazine's market dynamics[3].

Pricing Dynamics

Pricing is a critical factor in the financial trajectory of methdilazine.

Regional Pricing Variations

Prices of methdilazine vary significantly across different regions. The report by Research and Markets provides pricing data by region, which is essential for understanding the market's financial health. For example, prices in Europe, Asia, and North America can differ due to local market conditions, regulatory frameworks, and competition[3].

Comparison with Global Trends

The average price per unit of prescription drugs, including antihistamines like methdilazine, is significantly higher in the U.S. compared to other OECD countries and the rest of the world. This disparity can influence the global pricing strategy for methdilazine[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics and financial trajectory of methdilazine.

Product Approvals and Recalls

Regulatory approvals and recalls can significantly impact the market. For instance, product recalls by regulatory authorities like the U.S. FDA can hinder market growth, as seen in the broader pharmaceutical market. Ensuring compliance with regulatory standards is essential for maintaining market presence[1].

Market Authorization

Market authorization by regulatory bodies can offer growth opportunities. The validation of market authorization applications, such as those seen in the advanced drug delivery systems market, can boost the growth of specific pharmaceutical products, including methdilazine[1].

Research and Development

Research and development (R&D) efforts are vital for the long-term financial health of methdilazine.

Innovation in Pharmaceutical Development

The shift towards precision medicines and advanced drug delivery systems is changing the economics of drug development. Increased R&D activities, such as those seen in the advanced drug delivery systems market, can drive growth and innovation in the pharmaceutical industry, including for methdilazine[4].

Clinical Trials and Product Development

The success of clinical trials and the development of new products can significantly impact the market. For example, favorable findings from clinical trials, as seen with other pharmaceuticals, can lead to increased market authorization and subsequent growth[1].

Financial Projections

The financial trajectory of methdilazine is closely tied to the broader pharmaceutical market trends.

Growth Prospects

Given the increasing demand for antihistamines and the overall growth in the pharmaceutical market, methdilazine is likely to see steady growth. However, this growth will be influenced by factors such as pricing, regulatory compliance, and R&D investments[2][3].

Challenges and Opportunities

The market faces challenges such as product recalls and regulatory hurdles, but it also presents opportunities through market authorization and R&D advancements. Navigating these challenges and capitalizing on opportunities will be crucial for the financial success of methdilazine[1][3].

Key Takeaways

  • Manufacturers and Suppliers: The market is dominated by companies in Europe, Asia, and North America.
  • End-Use Sectors: Primarily used in the pharmaceutical industry as an antihistamine.
  • Pricing Dynamics: Prices vary by region, with significant differences between the U.S. and other OECD countries.
  • Regulatory Environment: Regulatory approvals and recalls are critical factors.
  • Research and Development: Increased R&D efforts can drive growth and innovation.
  • Financial Projections: Steady growth expected, influenced by market trends and regulatory factors.

FAQs

Q: What is the primary use of methdilazine? A: Methdilazine is primarily used as an antihistamine in the pharmaceutical industry.

Q: Which regions dominate the methdilazine market? A: The market is dominated by manufacturers and suppliers in Europe, Asia, and North America.

Q: How do regulatory environments impact methdilazine's market dynamics? A: Regulatory approvals and recalls significantly influence the market growth and financial health of methdilazine.

Q: What role does R&D play in the financial trajectory of methdilazine? A: Increased R&D efforts can drive growth and innovation, leading to better market prospects for methdilazine.

Q: How does the pricing of methdilazine vary globally? A: Prices of methdilazine vary significantly across different regions, with the U.S. having higher prices compared to other OECD countries and the rest of the world.

Cited Sources

  1. Coherent Market Insights, "Global Advanced Drug Delivery Systems Market to Surpass US$ 343.5 Billion by 2030, Says Coherent Market Insights (CMI)"[1].
  2. ASPE, "Issue Brief 1: Comparing U.S. and International Market Size and Average Pricing for Prescription Drugs, 2017-2022"[2].
  3. Research and Markets, "Methdilazine (CAS 1982-37-2) Market Research Report 2019"[3].
  4. NBER, "The Economics of Drug Development: Pricing and Innovation in a Changing Market"[4].

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