MINIZIDE Drug Patent Profile

When do Minizide patents expire, and what generic alternatives are available?

Minizide is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in MINIZIDE is polythiazide; prazosin hydrochloride. There is one drug master file entry for this compound. Additional details are available on the polythiazide; prazosin hydrochloride profile page.

Summary for MINIZIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	7
Patent Applications:	7
DailyMed Link:	MINIZIDE at DailyMed

US Patents and Regulatory Information for MINIZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	MINIZIDE	polythiazide; prazosin hydrochloride	CAPSULE;ORAL	017986-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	MINIZIDE	polythiazide; prazosin hydrochloride	CAPSULE;ORAL	017986-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	MINIZIDE	polythiazide; prazosin hydrochloride	CAPSULE;ORAL	017986-003	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for MINIZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	MINIZIDE	polythiazide; prazosin hydrochloride	CAPSULE;ORAL	017986-003	Approved Prior to Jan 1, 1982
Pfizer	MINIZIDE	polythiazide; prazosin hydrochloride	CAPSULE;ORAL	017986-001	Approved Prior to Jan 1, 1982
Pfizer	MINIZIDE	polythiazide; prazosin hydrochloride	CAPSULE;ORAL	017986-002	Approved Prior to Jan 1, 1982
Pfizer	MINIZIDE	polythiazide; prazosin hydrochloride	CAPSULE;ORAL	017986-002	Approved Prior to Jan 1, 1982

International Patents for MINIZIDE

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

Country	Patent Number	Title	Estimated Expiration
Philippines	13965	METHODS FOR TREATING CONGESTIVE HEART FAILURE AND ISCHEMIC HEART DISEASE
Belgium	868843

MINIZIDE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Generic Drugs: A Case Study on the Impact of Patent Expiries

Introduction

The pharmaceutical industry is undergoing significant changes, driven largely by patent expiries, increasing demand for generics, and evolving market dynamics. This article will delve into the market dynamics and financial trajectory of generic drugs, using the context of patent expiries and the impact on drugs like those similar to MINIZIDE, a generic version of a diuretic medication.

Patent Expiries and Generic Drug Market

Patent expiries are a crucial factor in the growth of the generic drug market. When patents expire, generic manufacturers can enter the market, offering cheaper alternatives to branded drugs. According to KPMG, the next wave of patent expiries is expected to create significant opportunities for generics manufacturers, with the global generics market projected to grow at a CAGR of 5.4% and reach sales of $497 billion by 2025[1].

Market Growth and Demand

The demand for generic drugs is driven by rising healthcare costs and the need for cost-effective treatments. In many countries, including those with historically low generics utilization, there is a growing trend towards increased use of generics. For example, in Japan, generics penetration rose from 30% to 68% over the last decade and is expected to reach 80% by the end of 2023[1].

Financial Trajectory of Generic Drugs

The financial trajectory of generic drugs is influenced by several factors, including the number of patent expiries, competition from other generics manufacturers, and regulatory environments.

Impact of Patent Expiries

Patent expiries open up significant opportunities for generics manufacturers. For instance, the expirations of small-molecule drugs are expected to nearly double by 2026, providing a fertile ground for generic versions to enter the market[1].

Competition and Pricing

The generics market is highly competitive, particularly with the rise of Indian and Chinese manufacturers. These manufacturers accounted for about 52% of all abbreviated new drug applications (ANDA) in 2019, with Indian manufacturers alone accounting for 45% of all ANDA approvals. This competition has led to a reduction in generics prices worldwide, reducing incentives for new product launches and affecting the profitability of generics manufacturers[1].

Regulatory Environment

Regulatory environments also play a critical role. The expedited FDA generics approval process has accelerated the supply of generic drugs, but this increased supply can sometimes outstrip demand, leading to price declines. Additionally, quality and compliance issues, especially in low-cost manufacturing markets like India and China, can hinder supply and impact market dynamics[1].

Regional Market Analysis

The generics market varies significantly across different regions.

United States

In the U.S., the generics market is substantial, with a significant portion of the prescription drug market consisting of generic drugs. The U.S. market for sterile injectable drugs, which includes some generic versions, was estimated at $203.1 billion in 2023 and is expected to grow further[3].

Japan

Japan has seen a remarkable increase in generics penetration, rising from 30% to 68% over the last decade. This trend is expected to continue, driven by government policies aimed at reducing healthcare costs[1].

Asia-Pacific

The Asia-Pacific region, including countries like China, is also experiencing rapid growth in the generics market. China's generics market is forecasted to grow at an impressive 9.0% CAGR to reach $213.0 billion by 2030[3].

Impact on Specific Drug Categories

Different drug categories are affected differently by these market dynamics.

Small Molecule Drugs

Small molecule drugs, which include many generic versions of branded drugs, have seen a relatively flat spending pattern despite an increase in the number of prescriptions. This indicates a drop in the price per small molecule drug, reflecting the competitive nature of the generics market[4].

Large Molecule Drugs and Biosimilars

Large molecule drugs, including biologics and biosimilars, are gaining traction, especially in the context of personalized and precision medicine. The global market for sterile injectable drugs, which includes biologics and gene therapies, is projected to reach $1.4 trillion by 2030, growing at a CAGR of 9.7% from 2023 to 2030[3].

Challenges and Opportunities

Quality and Compliance Issues

Generics manufacturers face significant challenges related to quality and compliance, particularly when outsourcing manufacturing to less expensive markets. For instance, 49% of FDA warning letters and 64% of EMA compliance notices between 2018 and 2019 were for facilities in India or China[1].

Market Consolidation

Consolidation in the drug buyer market, such as through consortia, further exacerbates pricing pressures on generics manufacturers. This can lead to decreased profitability and even market exit for some manufacturers[1].

Innovation and Personalized Medicine

Despite the challenges, there are opportunities for innovation, especially in the realm of personalized and precision medicine. Sterile injectable drugs, including biologics and gene therapies, are at the forefront of this trend, offering targeted treatments tailored to individual patient characteristics[3].

Key Takeaways

• Patent Expiries: The next wave of patent expiries will significantly impact the generics market, offering opportunities for growth.
• Market Competition: The generics market is highly competitive, with Indian and Chinese manufacturers playing a dominant role.
• Regulatory Environment: Expedited FDA approvals and compliance issues in low-cost manufacturing markets are critical factors.
• Regional Growth: Different regions, such as the U.S., Japan, and the Asia-Pacific, exhibit varying growth trajectories.
• Drug Categories: Small molecule drugs face pricing pressures, while large molecule drugs and biosimilars are gaining traction.

FAQs

What is the projected growth rate of the global generics market?

The global generics market is projected to grow at a CAGR of 5.4% and reach sales of $497 billion by 2025[1].

How does the patent expiry of branded drugs impact the generics market?

Patent expiries open up significant opportunities for generics manufacturers to enter the market with cheaper alternatives, driving market growth and competition[1].

What are the main challenges faced by generics manufacturers?

Generics manufacturers face challenges related to quality and compliance, market consolidation, and pricing pressures, which can affect their profitability and market presence[1].

How is the rise of personalized and precision medicine influencing the generics market?

The rise of personalized and precision medicine is driving the adoption of sterile injectable drugs, including biologics and gene therapies, which are at the forefront of targeted treatments[3].

What is the impact of regulatory environments on the generics market?

Regulatory environments, such as expedited FDA approvals and compliance issues in low-cost manufacturing markets, significantly influence the supply and quality of generic drugs[1].

Sources

1. KPMG International - Generics 2030[1]
2. GlobeNewswire - Sterile Injectable Drugs Strategic Market Research Report 2024[3]
3. ASPE - Competition in Prescription Drug Markets, 2017-2022[4]