MINOCYCLINE HYDROCHLORIDE Drug Patent Profile

Which patents cover Minocycline Hydrochloride, and what generic alternatives are available?

Minocycline Hydrochloride is a drug marketed by Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, Nexus Pharms, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Chartwell Rx, Impax Labs Inc, Norvium Bioscience, Rising, Sandoz, Sun Pharm, Sun Pharm Inds Ltd, Zydus Pharms, Beximco Pharms Usa, Strides Pharma, Sun Pharm Industries, and Triax Pharms. and is included in twenty-eight NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Minocycline Hydrochloride

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

Summary for MINOCYCLINE HYDROCHLORIDE

US Patents:	0
Applicants:	23
NDAs:	28
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	258
Patent Applications:	2,938
Drug Prices:	Drug price information for MINOCYCLINE HYDROCHLORIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MINOCYCLINE HYDROCHLORIDE
What excipients (inactive ingredients) are in MINOCYCLINE HYDROCHLORIDE?	MINOCYCLINE HYDROCHLORIDE excipients list
DailyMed Link:	MINOCYCLINE HYDROCHLORIDE at DailyMed

See drug prices for MINOCYCLINE HYDROCHLORIDE

Recent Clinical Trials for MINOCYCLINE HYDROCHLORIDE

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

Sponsor	Phase
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)	Phase 1/Phase 2
Pontificia Universidad Catolica de Chile	Phase 1/Phase 2
Maimonides Medical Center	Phase 2/Phase 3

See all MINOCYCLINE HYDROCHLORIDE clinical trials

Pharmacology for MINOCYCLINE HYDROCHLORIDE

Drug Class	Tetracycline-class Drug
Physiological Effect	Decreased Prothrombin Activity

Medical Subject Heading (MeSH) Categories for MINOCYCLINE HYDROCHLORIDE

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for MINOCYCLINE HYDROCHLORIDE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for MINOCYCLINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZILXI	Topical Aerosol Foam	minocycline hydrochloride	1.50%	213690	1	2022-02-28
AMZEEQ	Topical Aerosol Foam	minocycline hydrochloride	4%	212379	1	2021-05-11
MINOCIN	Injection	minocycline hydrochloride	100 mg/vial	050444	1	2020-10-16
SOLODYN	Extended-release Tablet	minocycline hydrochloride	105 mg	050808	1	2010-12-13
SOLODYN	Extended-release Tablet	minocycline hydrochloride	55 mg	050808	1	2010-12-02
SOLODYN	Extended-release Tablet	minocycline hydrochloride	80 mg	050808	1	2010-10-27
SOLODYN	Extended-release Tablet	minocycline hydrochloride	65 mg and 115 mg	050808	1	2009-11-19

US Patents and Regulatory Information for MINOCYCLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Triax Pharms	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET;ORAL	050451-003	Aug 10, 1982		DISCN	Yes	No
Barr Labs Inc	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	065485-005	May 18, 2012		DISCN	No	No
Sun Pharm Inds Ltd	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	091118-006	Sep 25, 2014		DISCN	No	No
Aurobindo Pharma Ltd	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202261-003	Nov 19, 2012	AB	RX	No	No
Beximco Pharms Usa	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET;ORAL	215466-001	May 27, 2022	AB	RX	No	No

Market Dynamics and Financial Trajectory for Minocycline Hydrochloride

Market Overview

Minocycline hydrochloride, a tetracycline antibiotic, is widely used to treat various bacterial infections, including those affecting the skin, respiratory tract, gallbladder, and urinary tract. The market for minocycline hydrochloride is experiencing significant growth driven by several key factors.

Market Size and Growth

The minocycline hydrochloride market is forecast to reach US$18.8 million by 2027, growing at a Compound Annual Growth Rate (CAGR) of 2.3% from 2022 to 2027[1]. In a broader forecast period, the market is expected to grow at a CAGR of 3.10% from 2021 to 2028, driven by emerging markets and substantial investments in research and development[4].

Segment Analysis

By Application

The market is segmented into minocycline hydrochloride tablets, capsules, and gels. Minocycline hydrochloride tablets held the largest share of 38% in the market in 2021, primarily due to the rise in bacterial infections[1].

• Minocycline Hydrochloride Tablets: These are the most widely used form, particularly for treating acne and other skin infections.
• Minocycline Hydrochloride Capsules: Extended-release capsules, such as Emrosi™ approved by the U.S. FDA, are gaining traction for treating conditions like rosacea[2].
• Minocycline Hydrochloride Gels: Used for topical applications, these are effective in treating localized skin infections.

By Type

The market is divided into pharmaceutical grade and industrial grade minocycline hydrochloride.

• Pharmaceutical Grade: This segment dominates the market due to its widespread use in medical treatments[4].

By Geography

• Asia-Pacific (APAC): APAC dominated the market in 2021 with a 37% market share, driven by countries like China and India, which are significant producers of active pharmaceutical ingredients (APIs)[1].
• North America: This region accounts for the largest market share due to increased consumption for treating urinary tract infections and severe acne[4].
• Europe: Europe holds the second-largest market share, driven by the prevalence of respiratory diseases and advanced medical facilities[4].

Drivers of Growth

Increasing Prevalence of Bacterial Infections

The global rise in bacterial infections is a major driver of the minocycline hydrochloride market. As bacterial infections continue to increase, the demand for effective antibiotics like minocycline hydrochloride is also on the rise[3].

Advancements in Technology and R&D

Technological advancements in treatment and diagnosis, along with significant investments in research and development, are boosting the market growth. New formulations, such as extended-release capsules, are enhancing the efficacy and patient compliance of minocycline hydrochloride treatments[4].

Growing Healthcare Expenditure

Increasing healthcare expenditure, particularly in the Asia-Pacific region, is contributing to the market's growth. Countries like India and China are investing heavily in healthcare infrastructure and pharmaceutical research, which is driving the demand for minocycline hydrochloride[4].

Challenges and Restraints

Adverse Effects

Minocycline hydrochloride can produce severe side effects, including life-threatening skin rashes and permanent tooth discoloration in children under eight years old. These adverse effects can hamper market growth[1].

High Cost and Regulatory Hurdles

The high cost of the drug and strict government regulations regarding pharmaceutical manufacturing can restrict market growth. Additionally, the cost of raw materials and the complexity of the production process, involving palladium carbon hydrogenation and formaldehyde reactions, contribute to these challenges[1][4].

COVID-19 Impact

The COVID-19 pandemic has had a noticeable impact on the global economic growth, including the minocycline hydrochloride market. The shift in manufacturing units to produce pandemic-related medicines temporarily affected the demand and supply chain, restricting growth in 2021[1].

Competitive Landscape

The minocycline hydrochloride market is highly competitive, with several key players focusing on technology launches, acquisitions, and R&D activities. Companies like Journey Medical Corporation are gaining approvals for new formulations, such as Emrosi™, which is an extended-release capsule for treating rosacea[2].

Financial Trajectory

Revenue and Market Share

The market is expected to see steady revenue growth, driven by the increasing demand for minocycline hydrochloride. The pharmaceutical grade segment is likely to continue dominating the market, contributing significantly to the overall revenue[4].

Investments and R&D

Companies are investing heavily in research and development to improve the efficacy and safety of minocycline hydrochloride. These investments are crucial for maintaining market share and addressing the challenges posed by generic competition and regulatory hurdles[2][4].

Key Takeaways

• The minocycline hydrochloride market is forecast to reach US$18.8 million by 2027, growing at a CAGR of 2.3% from 2022 to 2027.
• The market is driven by the increasing prevalence of bacterial infections, technological advancements, and growing healthcare expenditure.
• Asia-Pacific and North America are key regions driving the market growth.
• Adverse effects, high costs, and regulatory challenges are significant restraints.
• The competitive landscape is characterized by significant R&D investments and new product approvals.

FAQs

Q: What is the forecasted market size for minocycline hydrochloride by 2027? A: The minocycline hydrochloride market is forecast to reach US$18.8 million by 2027[1].

Q: What are the primary drivers of the minocycline hydrochloride market? A: The primary drivers include the increasing prevalence of bacterial infections, technological advancements, and growing healthcare expenditure[3][4].

Q: Which region dominates the minocycline hydrochloride market? A: Asia-Pacific dominated the market in 2021, but North America is expected to hold a significant share due to increased consumption for treating urinary tract infections and severe acne[1][4].

Q: What are the common side effects of minocycline hydrochloride? A: Common side effects include life-threatening skin rashes and permanent tooth discoloration in children under eight years old[1].

Q: How has the COVID-19 pandemic impacted the minocycline hydrochloride market? A: The pandemic has temporarily affected the demand and supply chain, restricting growth in 2021 due to the shift in manufacturing units to produce pandemic-related medicines[1].

Citations

1. IndustryARC: Minocycline Hydrochloride Market Size Report, 2022-2027.
2. Biospace: Journey Medical Corporation Announces U.S. FDA Approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea.
3. MarkWide Research: Minocycline Hydrochloride Market 2024-2032 | Size, Share, Growth.
4. Data Bridge Market Research: Global Minocycline Hydrochloride Market - Industry Trends and Forecast to 2028.