Minocycline hydrochloride - Generic Drug Details

What are the generic sources for minocycline hydrochloride and what is the scope of freedom to operate?

Minocycline hydrochloride is the generic ingredient in ten branded drugs marketed by Journey, Alvogen, Bausch, Triax Pharms, Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, Lederle, Rempex, Nexus Pharms, Orapharma, 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, Epi Hlth, Beximco Pharms Usa, Strides Pharma, and Sun Pharm Industries, and is included in forty-one NDAs. There are thirty-one patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Minocycline hydrochloride has eighty-two patent family members in twenty-five countries.

There are fourteen drug master file entries for minocycline hydrochloride. Twenty-six suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for minocycline hydrochloride

International Patents:	82
US Patents:	31
Tradenames:	10
Applicants:	30
NDAs:	41
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	258
Patent Applications:	4,500
Drug Prices:	Drug price trends 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
Pontificia Universidad Catolica de Chile	Phase 1/Phase 2
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)	Phase 1/Phase 2
Maimonides Medical Center	Phase 2/Phase 3

See all minocycline hydrochloride clinical trials

Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 45MG BASE	TABLET, EXTENDED RELEASE;ORAL
		EQ 105MG BASE	Tablet, Extended Release; Oral
		EQ 80MG BASE	Tablet, Extended Release; Oral

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012		DISCN	No	No
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012		DISCN	No	No
Aurobindo Pharma Ltd	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202261-004	Sep 28, 2018	AB	RX	No	No
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes			Y
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-003	May 8, 2006		DISCN	Yes	No
Aurobindo Pharma Ltd	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202261-006	Jun 13, 2016	AB	RX	No	No

Expired US Patents for minocycline hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781-001	Feb 16, 2001
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-004	Jul 23, 2009
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-007	Aug 27, 2010
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-005	Jul 23, 2009
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-008	Aug 27, 2010

International Patents for minocycline hydrochloride

Country	Patent Number	Title	Estimated Expiration
Canada	2978573	COMPOSITIONS ET METHODES DE TRAITEMENT DE LA ROSACEE ET DE L'ACNEE (COMPOSITIONS AND METHODS FOR TREATING ROSACEA AND ACNE)
European Patent Office	2568987	COMPOSITIONS DE TÉTRACYCLINE (TETRACYCLINE COMPOSITIONS)
World Intellectual Property Organization (WIPO)	2011039637
United Kingdom	201016546
South Korea	102705507
Japan	5744976

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.