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Last Updated: December 22, 2024

MINOXIDIL (FOR MEN) Drug Patent Profile


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When do Minoxidil (for Men) patents expire, and what generic alternatives are available?

Minoxidil (for Men) is a drug marketed by Aurobindo Pharma, P And L, Taro, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hikma, L Perrigo Co, Sight Pharms, and Teva. and is included in twelve NDAs.

The generic ingredient in MINOXIDIL (FOR MEN) is minoxidil. There are eight drug master file entries for this compound. One hundred and five suppliers are listed for this compound. Additional details are available on the minoxidil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Minoxidil (for Men)

A generic version of MINOXIDIL (FOR MEN) was approved as minoxidil by WATSON LABS on March 3rd, 1987.

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Summary for MINOXIDIL (FOR MEN)
Drug patent expirations by year for MINOXIDIL (FOR MEN)
Recent Clinical Trials for MINOXIDIL (FOR MEN)

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

SponsorPhase
Industrial Farmacéutica Cantabria, S.A.Phase 1
BioClever 2005 S.L.Phase 3
Industrial Farmacéutica Cantabria, S.A.Phase 3

See all MINOXIDIL (FOR MEN) clinical trials

Pharmacology for MINOXIDIL (FOR MEN)
Drug ClassArteriolar Vasodilator
Physiological EffectArteriolar Vasodilation

US Patents and Regulatory Information for MINOXIDIL (FOR MEN)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma MINOXIDIL (FOR MEN) minoxidil AEROSOL, FOAM;TOPICAL 218616-001 Apr 22, 2024 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Copley Pharm MINOXIDIL (FOR MEN) minoxidil SOLUTION;TOPICAL 074500-001 May 23, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex Inc MINOXIDIL (FOR MEN) minoxidil SOLUTION;TOPICAL 074924-001 Apr 29, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva MINOXIDIL (FOR MEN) minoxidil SOLUTION;TOPICAL 074589-001 Apr 5, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma MINOXIDIL (FOR MEN) minoxidil SOLUTION;TOPICAL 074731-001 Dec 24, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
P And L MINOXIDIL (FOR MEN) minoxidil AEROSOL, FOAM;TOPICAL 208092-001 Feb 17, 2017 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

MINOXIDIL (FOR MEN) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Minoxidil for Men

Introduction to Minoxidil

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. Marketed under the brand name Rogaine®, it is available in 2% and 5% solutions, with the 5% solution approved for use only by men in the U.S.[2].

Global Market Size and Growth

The global minoxidil market is projected to achieve substantial financial milestones in the coming years. By 2033, the market size is anticipated to exceed USD 1.89 billion, growing at a Compound Annual Growth Rate (CAGR) of 4.65% from 2023 to 2033[1][3].

Regional Market Dynamics

North America

North America is expected to hold the largest share of the global minoxidil market during the forecast period. This dominance is driven by growing end-user demand and sufficient supply from key manufacturers. The prevalence of baldness, sparse scalps, and premature hair loss in this region has spurred corporations to launch a variety of hair care products, including minoxidil in various forms such as tablets, injections, capsules, and gels[1][3].

Europe

Europe is expected to show the fastest growth during the forecast period. The region's market trend, particularly in Germany, has been positive, with demand from the end-user pharmaceutical industry aligning with the total supply among market players. The substantial number of clinical studies and favorable market conditions in Europe contribute to its rapid growth[1][4].

Asia-Pacific

While the Asia-Pacific region is not as prominently mentioned in terms of market share, it still represents a significant market due to the growing awareness and demand for hair restoration products. Pharmaceutical innovations and lifestyle changes are driving factors in this region as well[3].

Growth Factors

High Prevalence of Androgenetic Alopecia

The high prevalence of severe androgenetic alopecia (AGA), particularly among males aged 30-40, is a major driver of demand in the minoxidil market. This condition has led to a significant increase in the use of minoxidil for hair growth promotion[3][4].

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 of hair growth medications in online and traditional media has also boosted the prospects in the minoxidil market. This increased visibility and awareness have driven consumer demand for minoxidil products[4].

Effectiveness of Minoxidil

Studies have consistently shown the effectiveness of minoxidil in treating male-pattern hair loss.

5% Minoxidil Solution

A 48-week, double-blind, placebo-controlled, randomized trial demonstrated that 5% topical minoxidil was significantly superior to 2% topical minoxidil and placebo in increasing hair regrowth. The 5% solution showed an earlier response to treatment and improved patients' psychosocial perceptions of hair loss[5].

Clinical Studies

One-year and four-month observational studies conducted in Germany showed that the 5% minoxidil solution was judged very effective to effective in stimulating new hair growth by a majority of the men involved. These studies also reported a rapid onset of action, decreased hair loss, and minimal side effects[2].

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. Discontinuing use can lead to a reversal of any hair growth achieved, which can be a deterrent for some users[3].

Limited Effectiveness

There is still a limited understanding of the efficacy of minoxidil, and patients with androgenetic alopecia have reported mild side effects. More studies are needed to assess the outcome of the use of the medication in increasing the hair count from baseline[4].

Competitive Analysis

The global minoxidil market is influenced by major players such as Johnson & Johnson (J&J) and Taisho Pharma. These companies play a significant role in driving market growth through their extensive product offerings and marketing efforts[3].

Financial Trajectory

  • By 2030, the global minoxidil market is estimated to reach $1,637.7 million, growing at a CAGR of 5.2% from 2023 to 2030[3].
  • Alternatively, the market size is anticipated to exceed $1.89 billion by 2033, growing at a CAGR of 4.65% from 2023 to 2033[1].

Key Takeaways

  • The global minoxidil market is driven by the high prevalence of androgenetic alopecia, pharmaceutical innovations, and lifestyle changes.
  • North America and Europe are key regions, with North America holding the largest share and Europe expected to grow the fastest.
  • The 5% minoxidil solution has been shown to be highly effective in treating male-pattern hair loss.
  • Despite challenges such as gradual results and limited effectiveness, the market holds promise with opportunities for growth and innovation.
  • Major players like J&J and Taisho Pharma significantly influence the market.

Frequently Asked Questions (FAQs)

What is the projected market size of the global minoxidil market by 2033?

  • The global minoxidil market is estimated to exceed $1.89 billion by 2033[1].

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[1].

Which region is expected to hold the largest share in the global minoxidil market?

  • North America is expected to hold the largest share of the global minoxidil market during the forecast period[1][3].

What are the key growth factors driving the minoxidil market?

  • High prevalence of androgenetic alopecia, pharmaceutical innovations, and marketing and advertising efforts are key growth factors[3][4].

How effective is the 5% minoxidil solution in treating male-pattern hair loss?

  • The 5% minoxidil solution has been shown to be highly effective in stimulating new hair growth, with a majority of patients reporting very effective to effective results[2][5].

Sources Cited:

  1. Spherical Insights: Global Minoxidil Market Size, Share, Forecasts To 2033.
  2. ISHRS: Effectiveness of 5% Minoxidil in Treating Male-Pattern Hair Loss.
  3. Drug Patent Watch: Generic MINOXIDIL INN equivalents, pharmaceutical patent expiry.
  4. BioSpace: Minoxidil Market: Key Trends - Global Industry Analysis [2020-2030].
  5. PubMed: A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo.

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