Minoxidil - Generic Drug Details

What are the generic sources for minoxidil and what is the scope of patent protection?

Minoxidil is the generic ingredient in twelve branded drugs marketed by Johnson And Johnson, Perrigo Pharma Intl, Aurobindo Pharma, P And L, Taro, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hikma, L Perrigo Co, Sight Pharms, Teva, Avacor Prods, Perrigo, Perrigo New York, Pure Source, Pfizer, Quantum Pharmics, Endo Operations, Royce Labs, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for minoxidil. One hundred and five suppliers are listed for this compound.

Summary for minoxidil

US Patents:	0
Tradenames:	12
Applicants:	24
NDAs:	35
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	105
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	62
Patent Applications:	6,974
Drug Prices:	Drug price trends for minoxidil
What excipients (inactive ingredients) are in minoxidil?	minoxidil excipients list
DailyMed Link:	minoxidil at DailyMed

See drug prices for minoxidil

Recent Clinical Trials for minoxidil

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

Sponsor	Phase
Industrial Farmacéutica Cantabria, S.A.	Phase 1
Industrial Farmacéutica Cantabria, S.A.	Phase 3
Bioskin GmbH	Phase 3

See all minoxidil clinical trials

Pharmacology for minoxidil

Drug Class	Arteriolar Vasodilator
Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for minoxidil

Antihypertensive Agents

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for minoxidil

C02DC	Pyrimidine derivatives
C02D	ARTERIOLAR SMOOTH MUSCLE, AGENTS ACTING ON
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for MINOXIDIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
WOMEN'S ROGAINE	Topical Aerosol Foam	minoxidil	5%	021812	1	2015-02-04
WOMEN'S ROGAINE	Topical Aerosol Foam	minoxidil	5%	021812	1	2009-04-06

US Patents and Regulatory Information for minoxidil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	MINOXIDIL (FOR WOMEN)	minoxidil	AEROSOL, FOAM;TOPICAL	209074-002	Apr 22, 2019		OTC	No	No
Apotex Inc	MINOXIDIL EXTRA STRENGTH (FOR MEN)	minoxidil	SOLUTION;TOPICAL	075839-001	Oct 1, 2001		DISCN	No	No
Endo Operations	MINOXIDIL	minoxidil	TABLET;ORAL	071826-001	Nov 14, 1988	AB	RX	No	No
Watson Labs	MINOXIDIL	minoxidil	TABLET;ORAL	071344-001	Mar 3, 1987	AB	RX	No	No
Hikma	MINOXIDIL (FOR MEN)	minoxidil	SOLUTION;TOPICAL	074731-001	Dec 24, 1996		DISCN	No	No
Pfizer	LONITEN	minoxidil	TABLET;ORAL	018154-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for minoxidil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Johnson And Johnson	MEN'S ROGAINE	minoxidil	AEROSOL, FOAM;TOPICAL	021812-001	Jan 20, 2006	6,946,120
Pfizer	LONITEN	minoxidil	TABLET;ORAL	018154-003	Approved Prior to Jan 1, 1982	3,461,461
Pfizer	LONITEN	minoxidil	TABLET;ORAL	018154-001	Approved Prior to Jan 1, 1982	3,461,461
Johnson And Johnson	WOMEN'S ROGAINE	minoxidil	AEROSOL, FOAM;TOPICAL	021812-002	Feb 28, 2014	6,946,120

Minoxidil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Minoxidil

Market Overview

Minoxidil, initially developed as a vasodilator to treat hypertension, has found a significant niche in the hair care and pharmaceutical industries as a hair regrowth solution. The global Minoxidil market is a dynamic ecosystem where scientific advancements meet consumer demand for effective hair restoration products[1].

Growth Factors

The expansion of the global Minoxidil market is driven by several key factors:

High Prevalence of Androgenetic Alopecia

The high prevalence of severe androgenetic alopecia (AGA) is a major driver of demand in the Minoxidil market. This condition, particularly common among males aged 30-40, has led to a significant increase in the use of Minoxidil for hair growth promotion[3].

Pharmaceutical Innovations

Continuous efforts by pharmaceutical companies to expand the understanding of Minoxidil's pharmacology and clinical efficacy have boosted its market presence. These companies are developing new topical medications for dermatological conditions, further enhancing the market's growth[3].

Marketing and Advertising

Incessant advertising by brands in both online and traditional media has also played a crucial role in boosting the prospects of the Minoxidil market. This increased visibility has heightened consumer awareness and driven demand for hair growth medications[3].

Lifestyle Changes and Economic Factors

Changes in lifestyle, increased disposable income, and a growing awareness of hair-related issues have contributed to the market's expansion, particularly in regions like North America and Europe[1][4].

Market Segmentation

Regional Analysis

• North America: This region stands out as a prominent player in the Minoxidil market, driven by a robust healthcare infrastructure and heightened awareness of hair-related issues. The demand for Minoxidil products is further fueled by lifestyle changes and increased disposable income[1][4].
• Europe: Europe is expected to grow at the fastest CAGR during the forecast period. The region's substantial number of studies on the clinical efficacy and safety of Minoxidil solutions has made it an attractive market for industry players[3][4].
• Asia-Pacific: Rapid urbanization and changing lifestyles in countries like China and India have propelled the demand for hair care products, including those containing Minoxidil. Understanding the specific needs and preferences of consumers in this region is crucial for market participants[1].
• Middle East and Africa: This region presents a unique market landscape influenced by economic conditions, cultural attitudes towards personal care, and regulatory frameworks. Recognizing these factors is essential for stakeholders aiming to establish a foothold in the Minoxidil market[1].

Distribution Channels

Key distribution channels for Minoxidil include hospital pharmacies, retail pharmacies, and online pharmacies. The availability of Minoxidil in various forms such as tablets, injections, capsules, and gels also contributes to its market growth[3][4].

Competitive Analysis

The global Minoxidil market is influenced by several key players:

Johnson & Johnson (J&J)

J&J is a prominent player in the Minoxidil industry, contributing significantly to the market's structure with its well-established reputation and extensive resources in production and distribution[1].

Taisho Pharma

Taisho Pharma is another key player, adding diversity to the competitive landscape with its strategies and innovations in the development and growth of the Minoxidil market[1].

Other Key Players

Other notable companies in the Minoxidil market include Par Pharmaceuticals, Provizer Pharma, Bakul Group of companies, and several others. These companies play a crucial role in shaping the market dynamics through their core competencies and competitive strategies[4].

Financial Trajectory

Market Size and Growth

The global Minoxidil market is estimated to reach significant financial milestones:

• By 2030, the market is projected to reach $1,637.7 million, growing at a CAGR of 5.2% from 2023 to 2030[1].
• Alternatively, the market size is anticipated to exceed $1.89 billion by 2033, growing at a CAGR of 4.65% from 2023 to 2033[4].

Regional Revenue Streams

North America is expected to hold the largest share of the global Minoxidil market over the forecast period, driven by growing end-user demand and sufficient supply from key manufacturers. Europe is also expected to show rapid growth, particularly due to the substantial number of clinical studies and favorable market conditions[3][4].

Challenges and Limitations

Despite the promising growth, the Minoxidil market faces several challenges:

Gradual Results and Maintenance

Minoxidil hair loss treatment requires consistent use over several months to see noticeable results, and discontinuing use can lead to a reversal of any hair growth achieved[2].

Limited Effectiveness

Minoxidil is most effective for the early stages of hair loss and may not be suitable for all types of hair loss or advanced cases. This limitation can affect its market appeal for some consumers[2].

Potential Side Effects

Common side effects such as scalp irritation, itching, and dryness can deter some users, necessitating the exploration of alternative hair loss treatments[2].

Opportunities and Future Outlook

The Minoxidil market presents several opportunities for growth and innovation:

• Seizing New Markets: The Asia-Pacific region, with its burgeoning population and increasing concerns about hair health, offers significant growth potential.
• Innovative Products: Continuous research and development in topical medications for dermatological conditions can lead to new and more effective products.
• Strategic Marketing: Effective marketing strategies, including online and traditional advertising, can further boost consumer awareness and demand[1][3].

Key Takeaways

• The global Minoxidil market is driven by the high prevalence of androgenetic alopecia, pharmaceutical innovations, and lifestyle changes.
• Key regions include North America, Europe, and the Asia-Pacific, each with unique market dynamics.
• Major players like J&J and Taisho Pharma significantly influence the market.
• Despite challenges, the market holds promise with opportunities for growth and innovation.
• The financial trajectory indicates a substantial increase in market size, reaching $1,637.7 million by 2030 or $1.89 billion by 2033.

Frequently Asked Questions (FAQs)

1. What is the projected market size of the global Minoxidil market by 2030?

   • The global Minoxidil market is estimated to reach $1,637.7 million by 2030[1].

2. What is the CAGR of the global Minoxidil market from 2023 to 2033?

   • The market is expected to grow at a CAGR of 4.65% from 2023 to 2033[4].

3. Which region is expected to hold the largest share in the global Minoxidil market?

   • North America is projected to hold the largest share of the global Minoxidil market over the forecast period[4].

4. What are the common side effects of Minoxidil hair loss treatment?

   • Common side effects include scalp irritation, itching, and dryness[2].

5. Why is Minoxidil more effective for early stages of hair loss?

   • Minoxidil is most effective for the early stages of hair loss because it can stimulate hair growth by improving blood flow to hair follicles, but its effectiveness diminishes in advanced cases[2].

Cited Sources:

1. Metastatin Insight - Minoxidil Market Size, Share, Growth and Forecast by 2030
2. Eugenix Hair Sciences - Minoxidil for Hair Loss: Treatment, Effectiveness and Limitations
3. Biospace - Minoxidil Market: Key Trends - Global Industry Analysis [2020-2030]
4. Spherical Insights - Global Minoxidil Market Size, Share, Forecasts To 2033
5. Industry Research Biz - Minoxidil Market: Detailed Insights and Forecast for 2024-2032