MINOLIRA Drug Patent Profile

Which patents cover Minolira, and what generic alternatives are available?

Minolira is a drug marketed by Epi Hlth and is included in one NDA. There is one patent protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in MINOLIRA is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Minolira

A generic version of MINOLIRA was approved as minocycline hydrochloride by WATSON LABS on December 30^th, 1991.

Summary for MINOLIRA

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	95
Patent Applications:	2,938
Drug Prices:	Drug price information for MINOLIRA
DailyMed Link:	MINOLIRA at DailyMed

See drug prices for MINOLIRA

US Patents and Regulatory Information for MINOLIRA

MINOLIRA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Epi Hlth	MINOLIRA	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209269-001	May 8, 2017		DISCN	No	No			Y
Epi Hlth	MINOLIRA	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209269-002	May 8, 2017		DISCN	No	No			Y

International Patents for MINOLIRA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016162754

MINOLIRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MINOLIRA

Introduction to MINOLIRA

MINOLIRA is an extended-release (ER) formulation of minocycline hydrochloride, a tetracycline antibiotic used to treat various bacterial infections, including acne, urinary tract infections, and respiratory diseases. Here, we will delve into the market dynamics and financial trajectory of MINOLIRA.

Market Overview

The minocycline hydrochloride market, which includes MINOLIRA, is expected to experience steady growth over the forecast period. The global minocycline hydrochloride market is projected to grow at a CAGR of 2.3% from 2022 to 2027, reaching a market size of approximately $18.8 million by 2027[4].

Key Market Drivers

Several factors drive the growth of the minocycline hydrochloride market, including MINOLIRA:

Increasing Bacterial Infections

The rise in bacterial infections, particularly in the skin, respiratory tract, gallbladder, and urinary tract, is a significant driver. Minocycline hydrochloride's effectiveness in treating these infections contributes to its market growth[4].

Technological Advancements

Advancements in treatment and diagnosis technologies also boost the market. The development of extended-release formulations like MINOLIRA enhances patient compliance and efficacy, further driving market growth[1].

Geographical Expansion

Asia-Pacific, particularly countries like China and India, is expected to dominate the market due to rapid increases in pharmaceutical manufacturing and healthcare expenditure. North America and Europe also hold significant market shares due to high consumption and advanced medical facilities[1][4].

Market Restraints

Despite the growth drivers, there are several restraints that could impact the market:

High Cost and Adverse Effects

The high cost of minocycline hydrochloride and its potential adverse effects, such as life-threatening skin rashes and permanent tooth discoloration in children, can hamper market growth[4].

Regulatory Challenges

Strict government regulations and the high cost of raw materials can also restrict market expansion. Compliance with FDA regulations and other international standards is crucial but can be costly and time-consuming[1].

Financial Trajectory

The financial trajectory of MINOLIRA and similar minocycline hydrochloride products is influenced by several factors:

Research and Development Costs

Pharmaceutical and biotechnology product development, including MINOLIRA, involves substantial upfront capital expenditures. These costs include license fees, milestone payments, clinical trials, and regulatory compliance, among others[2].

Revenue Projections

The minocycline hydrochloride market, including MINOLIRA, is forecast to reach $18.8 million by 2027. This growth is driven by increasing demand for generic medicines and the expanding pharmaceutical sector in regions like Asia-Pacific[4].

Challenges in Capital Access

Companies developing minocycline hydrochloride products, like Novan Inc., have faced significant financial challenges, including net losses and substantial accumulated deficits. Access to capital markets and strategic partnerships are critical for sustaining operations and advancing product development[2].

Bioequivalence and Regulatory Approval

MINOLIRA's market success is also tied to its bioequivalence and regulatory approval:

Bioequivalence Trials

MINOLIRA has demonstrated bioequivalence to the listed drug SOLODYN ER tablets in both fasting and fed conditions. This bioequivalence was established through several relative BA/BE trials, which are crucial for FDA approval[3].

Regulatory Pathway

MINOLIRA followed a 505(b)(2) regulatory pathway, which allows for the approval of new drugs based on existing data. This pathway can streamline the approval process but still requires rigorous clinical pharmacology studies[3].

Geographical Market Share

The geographical distribution of the minocycline hydrochloride market, including MINOLIRA, is significant:

Asia-Pacific Dominance

Asia-Pacific, led by countries like China and India, dominates the market with a significant share. This region's rapid growth in pharmaceutical manufacturing and healthcare expenditure drives the demand for minocycline hydrochloride[4].

North America and Europe

North America and Europe also hold substantial market shares due to high consumption rates and advanced medical facilities. These regions are particularly important for the treatment of urinary tract infections and respiratory diseases[1].

Impact of COVID-19

The COVID-19 pandemic has had a noticeable impact on the global minocycline hydrochloride market:

Supply Chain Disruptions

The pandemic led to temporary shutdowns of industrial activities, affecting the demand and supply chain of minocycline hydrochloride. This disruption restricted market growth in 2021 due to the shift in manufacturing units to produce pandemic-related medicines[4].

Key Takeaways

• Market Growth: The minocycline hydrochloride market, including MINOLIRA, is expected to grow at a CAGR of 2.3% from 2022 to 2027.
• Drivers: Increasing bacterial infections, technological advancements, and geographical expansion drive market growth.
• Restraints: High costs, adverse effects, and regulatory challenges can hamper market growth.
• Financial Trajectory: Significant R&D costs and challenges in accessing capital markets impact the financial health of companies developing these products.
• Regulatory Approval: Bioequivalence trials and FDA approval are critical for market success.

FAQs

1. What is MINOLIRA used for? MINOLIRA is an extended-release formulation of minocycline hydrochloride used to treat various bacterial infections, including acne, urinary tract infections, and respiratory diseases.

2. What is the expected market size of minocycline hydrochloride by 2027? The global minocycline hydrochloride market is projected to reach approximately $18.8 million by 2027[4].

3. Which region dominates the minocycline hydrochloride market? Asia-Pacific, particularly China and India, dominates the minocycline hydrochloride market due to rapid growth in pharmaceutical manufacturing and healthcare expenditure[4].

4. What are the key restraints for the minocycline hydrochloride market? High costs, adverse effects, and regulatory challenges are significant restraints for the market[1][4].

5. How has the COVID-19 pandemic impacted the minocycline hydrochloride market? The pandemic led to supply chain disruptions and a temporary shutdown of industrial activities, affecting the demand and supply chain of minocycline hydrochloride[4].

Sources Cited:

1. Data Bridge Market Research: Global Minocycline Hydrochloride Market - Industry Trends and Forecast to 2028.
2. Novan, Inc.: Bankruptcy Filing Document, Case 23-10937-LSS.
3. FDA: 209269Orig1s000 - MINOLIRA NDA Clinical Pharmacology Review.
4. IndustryARC: Minocycline Hydrochloride Market Size Report, 2022-2027.