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Last Updated: December 22, 2024

MINOXIDIL EXTRA STRENGTH (FOR MEN) Drug Patent Profile


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

Minoxidil Extra Strength (for Men) is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Avacor Prods, P And L, Perrigo, and Perrigo New York. and is included in six NDAs.

The generic ingredient in MINOXIDIL EXTRA STRENGTH (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 Extra Strength (for Men)

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

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

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

SponsorPhase
Industrial Farmacéutica Cantabria, S.A.Phase 1
Industrial Farmacéutica Cantabria, S.A.Phase 3
Bioskin GmbHPhase 3

See all MINOXIDIL EXTRA STRENGTH (FOR MEN) clinical trials

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

US Patents and Regulatory Information for MINOXIDIL EXTRA STRENGTH (FOR MEN)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075839-001 Oct 1, 2001 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
P And L MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075518-001 Nov 17, 2000 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075438-001 Feb 27, 2003 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Avacor Prods MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075619-001 Nov 17, 2000 DISCN 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 EXTRA STRENGTH (FOR MEN) Market Analysis and Financial Projection Experimental

Minoxidil Market Dynamics and Financial Trajectory

Introduction to Minoxidil

Minoxidil, a piperidino-pyrimidine derivative, has been a cornerstone in the treatment of androgenetic alopecia (AGA) for several decades. Initially approved as a topical solution for hair growth, minoxidil has also been used off-label in oral form to treat various forms of alopecia.

Market Size and Growth Projections

The global minoxidil market is projected to experience significant growth over the coming years. As of 2023, the market is valued at approximately $1.095 billion and is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.8% until 2030, reaching a projected value of $1.59 billion by 2032[3][4].

Key Drivers of Market Growth

Prevalence of Androgenetic Alopecia

The high prevalence of androgenetic alopecia, particularly among men aged 30-40, is a major driver of the minoxidil market. This condition affects a substantial portion of the population, creating a large and consistent demand for effective treatments[1].

Rise in Over-the-Counter (OTC) Hair Loss Treatments

The increasing availability and acceptance of OTC hair loss treatments have boosted the market. Consumers are more inclined to seek self-medication options, which has led to an increase in the sales of minoxidil products[4].

Expanding Clinical Avenues

Pharmaceutical companies are continuously expanding their understanding of minoxidil's pharmacology and clinical efficacy. This includes exploring new formulations and combinations, such as low-dose oral minoxidil, which has shown promising results in treating alopecia[2][3].

Market Segmentation

By Type

The minoxidil market is primarily segmented into 2% and 5% minoxidil solutions. These concentrations are available in various forms, including topical solutions and foams, as well as off-label oral tablets[1][4].

By Route of Administration

Minoxidil is administered both topically and orally. Topical formulations are the most common, but low-dose oral minoxidil is gaining popularity due to its efficacy and safety profile[2][3].

By Gender

Minoxidil is used by both men and women to treat hair loss. The market is segmented based on gender, with specific products tailored for each demographic[4].

By Distribution Channel

Key distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies. The rise of online pharmacies has significantly expanded the reach of minoxidil products[1][3].

Regional Analysis

North America

North America is a dominant region in the global minoxidil market, accounting for approximately 33.5% of the market share in 2023. This is due to the high prevalence of androgenetic alopecia and the strong presence of pharmaceutical companies in the region[3].

Europe

Europe is another significant market, driven by extensive clinical studies and regulatory approvals. The region has seen substantial investment in dermatologic care, which has boosted the demand for minoxidil[1].

Asia Pacific

The Asia Pacific region is expected to witness significant growth due to increasing inorganic growth strategies by key market players. Collaborations and agreements among companies are expanding the product portfolios and distribution networks in this region[3].

Competitive Landscape

The minoxidil market is highly competitive, with several key players such as Pfizer Inc., Johnson and Johnson Services, Inc., Merck KGaA, and Hims & Hers Health, Inc. These companies are engaged in various strategies including collaborations, product expansions, and distribution agreements to maintain their market share[1][3].

Challenges and Restraints

Side Effects and Efficacy Concerns

Despite its popularity, minoxidil is associated with several side effects, including itching, skin rash, and in rare cases, systemic effects such as dizziness and fluid retention. There is also a need for more studies to assess the long-term efficacy and safety of minoxidil, particularly in its oral form[2][5].

Regulatory Approval

Low-dose oral minoxidil, while effective, lacks official FDA approval due to its off-label use. This limits its widespread adoption and marketing[2].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the minoxidil market, primarily due to disruptions in production and distribution channels. However, the market has been recovering as normal operations resume[3].

Future Outlook and Trends

Increasing Research and Development

There is a growing focus on expanding the use of minoxidil for other conditions, such as late alopecia in cancer patients. This research is expected to drive market growth over the forecast period[3].

Combination Therapies

The use of minoxidil in combination with other treatments, such as topical retinoids, is becoming more common. This approach has shown improved efficacy and is likely to become a trend in the market[2].

Digital Health Platforms

The collaboration between pharmaceutical companies and digital health platforms, such as Hims & Hers Health, Inc., is expected to increase accessibility and convenience for consumers, further driving market growth[3].

Key Takeaways

  • The global minoxidil market is valued at $1.095 billion in 2023 and is expected to grow at a CAGR of 4.8% until 2030.
  • The high prevalence of androgenetic alopecia and the rise in OTC hair loss treatments are key drivers of the market.
  • Low-dose oral minoxidil is gaining popularity due to its safety and efficacy.
  • North America and Europe are dominant regions, with the Asia Pacific region expected to see significant growth.
  • The market is highly competitive, with several key players engaging in various growth strategies.

Frequently Asked Questions

What is the current market size of the minoxidil market?

The global minoxidil market was valued at approximately $1.095 billion in 2023[3].

What is the expected CAGR of the minoxidil market until 2030?

The minoxidil market is expected to exhibit a CAGR of 4.8% until 2030[3].

What are the primary types of minoxidil solutions available?

The primary types of minoxidil solutions are 2% and 5% minoxidil[1][4].

What are the common side effects associated with minoxidil use?

Common side effects include itching, skin rash, and in rare cases, systemic effects such as dizziness and fluid retention[5].

Is low-dose oral minoxidil FDA-approved for hair loss?

No, low-dose oral minoxidil is not FDA-approved for hair loss; it is used off-label[2].

Sources:

  1. Biospace: Minoxidil Market: Key Trends - Global Industry Analysis [2020-2030][1]
  2. Cleveland Clinic: Oral Minoxidil Offers Strong Results Against Alopecia[2]
  3. Coherent Market Insights: Minoxidil Market Size, Trends and Forecast to 2030[3]
  4. Business Research Insights: Minoxidil Market Size, Share, Trends | Forecast Report 2032[4]
  5. Mayo Clinic: Minoxidil (topical route) - Mayo Clinic[5]

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