MINOCIN Drug Patent Profile

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

Minocin is a drug marketed by Bausch, Triax Pharms, Lederle, and Rempex. and is included in five NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in twenty-two countries.

The generic ingredient in MINOCIN 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 Minocin

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

Summary for MINOCIN

International Patents:	30
US Patents:	3
Applicants:	4
NDAs:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	148
Clinical Trials:	44
Patent Applications:	2,826
Drug Prices:	Drug price information for MINOCIN
What excipients (inactive ingredients) are in MINOCIN?	MINOCIN excipients list
DailyMed Link:	MINOCIN at DailyMed

See drug prices for MINOCIN

See drug sales revenues for MINOCIN

Recent Clinical Trials for MINOCIN

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

Sponsor	Phase
Baystate Medical Center	Phase 2
Children's Hospital Medical Center, Cincinnati	Phase 1
Sun Yat-sen University	Phase 2

See all MINOCIN clinical trials

Pharmacology for MINOCIN

Drug Class	Tetracycline-class Drug
Physiological Effect	Decreased Prothrombin Activity

Paragraph IV (Patent) Challenges for MINOCIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MINOCIN	Injection	minocycline hydrochloride	100 mg/vial	050444	1	2020-10-16

US Patents and Regulatory Information for MINOCIN

MINOCIN is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	MINOCIN	minocycline hydrochloride	CAPSULE;ORAL	050649-001	May 31, 1990	AB	RX	Yes	No
Rempex	MINOCIN	minocycline hydrochloride	INJECTABLE;INJECTION	050444-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Triax Pharms	MINOCIN	minocycline hydrochloride	CAPSULE;ORAL	050315-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Rempex	MINOCIN	minocycline hydrochloride	INJECTABLE;INJECTION	050444-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes

International Patents for MINOCIN

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112012028524	composições farmacêuticas, respectivos usos e métodos de preparação, composição sólida solúvel em água e kits
Hungary	E033161
European Patent Office	2568987	COMPOSITIONS DE TÉTRACYCLINE (TETRACYCLINE COMPOSITIONS)
Japan	6290298

MINOCIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Minocycline Hydrochloride (MINOCIN)

Market Overview

Minocycline hydrochloride, marketed under the brand name MINOCIN among others, is a tetracycline antibiotic used to treat a variety of bacterial infections. The market for minocycline hydrochloride is characterized by several key dynamics that influence its growth and financial trajectory.

Market Size and Growth

The minocycline hydrochloride market is projected to experience steady growth over the forecast period. According to IndustryARC, the market size is expected to reach $18.8 million by 2027, growing at a CAGR of 2.3% from 2022 to 2027[4].

Segmentation

By Application

The market is segmented into various applications, including minocycline hydrochloride tablets, capsules, and gels. Minocycline hydrochloride tablets held the largest share of 38% in 2021, driven by the rise in bacterial infections[4].

By Type

The market is also segmented by type into pharmaceutical grade and industrial grade. Pharmaceutical grade minocycline hydrochloride is the dominant segment due to its widespread use in medical treatments[1][4].

By Geography

Geographically, the Asia-Pacific region dominated the market in 2021 with a 37% market share, followed by North America and Europe. Countries like China and India are significant players due to their large production of active pharmaceutical ingredients (APIs)[4].

Drivers of Growth

Increasing Bacterial Infections

The rise in bacterial infections, particularly in skin, respiratory tract, urinary tract, and other areas, is a major driver of the minocycline hydrochloride market. The increasing prevalence of these infections necessitates the use of effective antibiotics like minocycline hydrochloride[1][4].

Advancements in Drug Delivery Technologies

Advancements in drug delivery technologies have improved the efficacy and safety of minocycline hydrochloride, making it a preferred treatment option. For example, the FDA approval of Emrosi, a minocycline hydrochloride extended-release capsule, for the treatment of rosacea, highlights these advancements[2].

Research and Development

Significant investments in research and development are driving the market forward. Companies are continually developing new formulations and improving existing ones, such as the launch of generic versions of minocycline HCl by Teva Pharmaceutical Industries Ltd.[4].

Challenges and Restraints

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. These factors may deter some patients and healthcare providers from using the drug[1][4].

Regulatory Challenges

Strict government regulations and the high cost of raw materials can also restrict market growth. The regulatory environment, particularly the need for extensive clinical trials, adds to the complexity and cost of bringing new formulations to the market[1][4].

COVID-19 Impact

The COVID-19 pandemic has had a noticeable impact on the global minocycline hydrochloride market. The temporary shutdown of industrial activities and the shift in manufacturing priorities to produce pandemic-related medicines affected the demand and supply chain, restricting growth in 2021[4].

Key Players and Competitive Landscape

The minocycline hydrochloride market is competitive, with several major players including GlaxoSmithKline plc., Teva Pharmaceuticals Industries Ltd., Actelion Pharmaceuticals US, Inc., and Journey Medical Corporation. These companies are focused on innovation, with Journey Medical Corporation recently receiving FDA approval for Emrosi, a new treatment for rosacea[1][2].

Financial Trajectory

Revenue Projections

The market is expected to grow steadily, with revenue projections indicating a CAGR of 2.3% from 2022 to 2027. This growth is driven by increasing demand for minocycline hydrochloride in various medical applications[4].

Investment in R&D

High investments in research and development are creating numerous opportunities for market growth. Companies are investing heavily in developing new formulations and improving existing ones, which is expected to drive revenue in the coming years[1][4].

Geographical Revenue Distribution

North America currently holds the largest market share due to the high consumption of minocycline hydrochloride for treating urinary tract infections and severe acne. However, the Asia-Pacific region is expected to dominate the market in the future due to advancements in technology and growing healthcare expenditure[1].

Patient Epidemiology and Market Impact

The demand for minocycline hydrochloride is influenced by patient epidemiology, particularly the prevalence of bacterial infections. The Indian pharmaceutical industry, for example, is a significant player, with India being the world's largest supplier of generic medications and accounting for over 20% of the global generics market by volume[4].

Launch Strategies and Commercialization

Companies like Journey Medical Corporation are executing robust launch strategies to commercialize new products. The approval of Emrosi, for instance, is supported by positive data from Phase 3 clinical trials, and the company is preparing for a successful launch to establish Emrosi as a new standard of care for rosacea[2].

Key Takeaways

• The minocycline hydrochloride market is expected to grow at a CAGR of 2.3% from 2022 to 2027.
• The market is driven by increasing bacterial infections and advancements in drug delivery technologies.
• High costs, adverse effects, and regulatory challenges are significant restraints.
• Asia-Pacific is expected to dominate the market in the future due to growing healthcare expenditure.
• Key players are investing heavily in R&D to develop new formulations.

FAQs

1. What are the primary applications of minocycline hydrochloride?

Minocycline hydrochloride is used to treat a variety of bacterial infections, including those in the skin, respiratory tract, urinary tract, and other areas. It is also used in the treatment of rosacea and rheumatoid arthritis[1][2][4].

2. Which region dominates the minocycline hydrochloride market?

Currently, North America holds the largest market share, but the Asia-Pacific region is expected to dominate in the future due to advancements in technology and growing healthcare expenditure[1][4].

3. What are the major challenges facing the minocycline hydrochloride market?

The high cost of the drug, potential adverse effects, strict government regulations, and the high cost of raw materials are significant challenges. The COVID-19 pandemic also impacted the market by disrupting the supply chain[1][4].

4. Who are the key players in the minocycline hydrochloride market?

Key players include GlaxoSmithKline plc., Teva Pharmaceuticals Industries Ltd., Actelion Pharmaceuticals US, Inc., and Journey Medical Corporation[1][2].

5. How has the COVID-19 pandemic affected the minocycline hydrochloride market?

The pandemic affected the demand and supply chain, leading to a temporary shutdown of industrial activities and a shift in manufacturing priorities to produce pandemic-related medicines, which restricted market growth in 2021[4].

Cited Sources:

1. Data Bridge Market Research: Global Minocycline Hydrochloride Market - Industry Trends and Forecast to 2028[1].
2. Biospace: Journey Medical Corporation Announces U.S. FDA Approval of Emrosi Minocycline Hydrochloride Extended-Release Capsules[2].
3. MarkWide Research: Minocycline Hydrochloride Market 2024-2032 | Size, Share, Growth[3].
4. IndustryARC: Minocycline Hydrochloride Market Size Report, 2022-2027[4].