MYKROX Drug Patent Profile

When do Mykrox patents expire, and when can generic versions of Mykrox launch?

Mykrox is a drug marketed by Chartwell Molecular and is included in one NDA.

The generic ingredient in MYKROX is metolazone. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the metolazone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mykrox

A generic version of MYKROX was approved as metolazone by SANDOZ on December 19^th, 2003.

Summary for MYKROX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	87
Patent Applications:	4,006
DailyMed Link:	MYKROX at DailyMed

US Patents and Regulatory Information for MYKROX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Molecular	MYKROX	metolazone	TABLET;ORAL	019532-001	Oct 30, 1987		DISCN	No	No

Expired US Patents for MYKROX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chartwell Molecular	MYKROX	metolazone	TABLET;ORAL	019532-001	Oct 30, 1987

International Patents for MYKROX

See the table below for patents covering MYKROX around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	841696
Spain	8602418
Canada	1216236	COMPOSES PHARMACEUTIQUES UNIFORMES SE DISSOLVANT RAPIDEMENT ET METHODE DE PREPARATION (RAPID DISSOLVING, UNIFORM DRUG COMPOSITIONS AND THEIR PREPARATION)
Spain	531978
Ireland	57137	RAPID DISSOLVING,UNIFORM DRUG COMPOSITIONS AND THEIR PREPARATION

MYKROX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Generic Drugs: A Case Study Relevant to MYKROX

Introduction

The generic drug market is a vibrant and rapidly evolving sector within the pharmaceutical industry. To understand the market dynamics and financial trajectory of a generic drug like MYKROX, it is essential to delve into the broader trends and factors influencing the generic drug market.

Global Generic Drug Market Overview

The global market for generic drugs is projected to experience significant growth. By 2028, the market is expected to reach $655.8 billion, up from $407.2 billion in 2022, with a compound annual growth rate (CAGR) of 8.5% from 2023 to 2028[1].

Market Drivers

Several factors drive the growth of the generic drug market:

• Increasing Demand for Affordable Medications: The need for cost-effective treatments is a major driver, especially in regions with growing healthcare needs and limited budgets.
• Patent Expirations: As patents for branded drugs expire, generic versions can enter the market, offering cheaper alternatives.
• Regulatory Support: Government policies and regulations often favor the approval and use of generic drugs to control healthcare costs[1][3].

Geographic Market Segmentation

The generic drug market is segmented across various geographic regions:

• North America: The U.S. is a significant market, with generic drug sales projected to grow at a CAGR of 10.4% in certain periods.
• Europe: Countries like Germany, the U.K., and Italy are key markets.
• Asia-Pacific: Countries such as China and India are experiencing rapid growth due to large populations and increasing healthcare spending[1].

Therapeutic Categories

Generic drugs are prevalent across various therapeutic categories:

• Cardiovascular Drugs: These represent nearly 21% of the generic prescription drug market.
• Anti-infectives and Antiarthritics/Analgesics: These categories are also significant, with market shares of 14.4% and 14.0%, respectively[1].

Competitive Landscape

The generic drug market is highly competitive:

• Price Dynamics: Generic drug prices fall with the number of competitors, but they remain above long-run marginal costs until there are 8 or more competitors[3].
• Entry and Exit: More firms enter markets with greater expected rents, and the entry process is influenced by regulatory and market factors[3].

Financial Performance of Generic Drugs

The financial performance of generic drugs can be illustrated through the example of other successful generic drugs:

• Revenue Growth: For instance, the U.S. generic drug market has seen significant revenue growth, with sales increasing from $11.1 billion in 2001 to over $19 billion in 2006, representing an average annual growth rate (AAGR) of 11.4%[1].
• Cost and Profit Margins: Generic drug prices decline as more competitors enter the market, affecting profit margins. However, the initial generic monopolist can enjoy prices 35% to 50% above long-run marginal costs[3].

Impact of Regulatory Changes

Regulatory changes can significantly impact the generic drug market:

• FDA Scrutiny: Increased scrutiny of generic drug applications can raise the cost of obtaining approval, affecting market entry and prices[3].
• Inflation Reduction Act (IRA): The IRA has led manufacturers to adjust their portfolios and R&D strategies, emphasizing indication stacking and early lifecycle evidence to support value conversations[4].

Market Access Trends

Several trends are shaping market access for generic drugs:

• Biosimilar Adoption: Despite discounts, biosimilar adoption has been slow due to strategies by innovators to maintain market share. However, biosimilars are expected to gain traction over time[4].
• Cash Pay Options and Discount Pharmacies: The rise of cash pay options and discount pharmacies is altering traditional market models, with over 8.5% of the U.S. drug universe now moving through the cash channel[4].

Financial Trajectory for MYKROX

While specific financial data for MYKROX is not provided, the financial trajectory for a generic drug like MYKROX can be inferred from broader market trends:

• Initial Market Entry: Upon entering the market, MYKROX would likely enjoy higher prices and profit margins as an initial generic entrant.
• Competition and Price Decline: As more competitors enter the market, prices would decline, and profit margins would shrink. However, the drug would still remain profitable due to lower production costs compared to branded versions[3].
• Revenue Growth: MYKROX could experience significant revenue growth, especially if it targets high-demand therapeutic categories and benefits from favorable regulatory environments.

Key Takeaways

• The global generic drug market is growing rapidly, driven by increasing demand for affordable medications and patent expirations.
• Geographic regions like North America, Europe, and Asia-Pacific are crucial for generic drug sales.
• Therapeutic categories such as cardiovascular drugs and anti-infectives are significant segments.
• The competitive landscape is characterized by price dynamics and regulatory influences.
• Financial performance is influenced by market entry, competition, and regulatory changes.
• Market access trends, including biosimilar adoption and cash pay options, are shaping the future of generic drugs.

FAQs

What is the projected growth rate of the global generic drug market?

The global generic drug market is expected to grow at a CAGR of 8.5% from 2023 to 2028[1].

How do regulatory changes impact the generic drug market?

Regulatory changes, such as increased FDA scrutiny and policies like the Inflation Reduction Act, can affect market entry, prices, and the overall competitiveness of the market[3][4].

What are the major therapeutic categories for generic drugs?

Cardiovascular drugs, anti-infectives, and antiarthritics/analgesics are among the largest generic drug categories[1].

How does competition affect generic drug prices?

Generic drug prices fall with the number of competitors but remain above long-run marginal costs until there are 8 or more competitors[3].

What role do biosimilars play in the generic drug market?

Biosimilars, despite initial slow adoption, are expected to gain market share over time, especially as innovators' strategies to maintain market share evolve[4].

How are cash pay options and discount pharmacies impacting the market?

These options are increasing, with over 8.5% of the U.S. drug universe now moving through the cash channel, altering traditional market models and pricing strategies[4].

Sources

1. BCC Research: Global Markets for Generic Drugs - BCC Research.
2. Blueprint Medicines: Blueprint Medicines Reports Fourth Quarter and Full Year 2022.
3. Federal Trade Commission: Generic Drug Industry Dynamics.
4. IQVIA: Top 10 U.S. Market Access Trends for 2024.
5. NBER: The Economics of Drug Development: Pricing and Innovation in a Changing Market.