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Last Updated: December 22, 2024

ROGAINE (FOR MEN) Drug Patent Profile


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Which patents cover Rogaine (for Men), and when can generic versions of Rogaine (for Men) launch?

Rogaine (for Men) is a drug marketed by Johnson And Johnson and is included in one NDA.

The generic ingredient in ROGAINE (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 Rogaine (for Men)

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

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

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

SponsorPhase
Ohio State University Comprehensive Cancer CenterEarly Phase 1
Loyola UniversityPhase 2
Cures Within ReachPhase 2

See all ROGAINE (FOR MEN) clinical trials

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

US Patents and Regulatory Information for ROGAINE (FOR MEN)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Johnson And Johnson ROGAINE (FOR MEN) minoxidil SOLUTION;TOPICAL 019501-002 Feb 9, 1996 OTC Yes Yes ⤷  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

ROGAINE (FOR MEN) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ROGAINE (For Men)

Introduction to ROGAINE

ROGAINE, known generically as minoxidil, is a topical medication that has revolutionized the treatment of hereditary hair loss. First discovered in the 1980s as a side effect of minoxidil's use for other medical conditions, it has since become the only FDA-approved topical ingredient for hair regrowth[2].

Historical Development of ROGAINE

The journey of ROGAINE began with its initial approval as a prescription-only solution for men in the form of a 2% minoxidil solution. Over the years, the product has evolved, with the introduction of a 2% solution for women, followed by a higher-dose 5% solution for men, and eventually the development of a 5% minoxidil foam for both men and women. These innovations have made ROGAINE more accessible and effective for a broader range of users[2].

Market Trends and Drivers

Growing Demand for Hair Loss Treatments

The minoxidil market is driven by the high prevalence of androgenetic alopecia (AGA), particularly among men aged 30-40. This demographic is increasingly seeking effective treatments for hair loss, making minoxidil a key player in the market[1].

Pharmaceutical Innovations

Constant efforts by pharmaceutical companies to expand topical medications for dermatological conditions have boosted the prospects of the minoxidil market. The development of new formulations, such as foams and higher concentration solutions, has enhanced the product's efficacy and user experience[1].

Marketing and Advertising

Aggressive marketing and advertising by brands, both online and in traditional media, have significantly increased awareness and demand for hair growth medications like ROGAINE. This increased visibility has contributed to the market's growth[1].

Regional Market Analysis

North America

North America holds the largest share of the global minoxidil market. The region's high demand for hair care products, driven by the prevalence of baldness, sparse scalps, and premature hair loss, has prompted companies to launch superior hair care solutions. The availability of minoxidil in various forms, including tablets, injections, capsules, and gels, further supports market growth in this region[3][4].

Europe

Europe is expected to grow at the fastest CAGR during the forecast period. Despite an uneven market trend, particularly in Germany, the demand from the pharmaceutical sector aligns well with the supply, indicating strong market potential. Europe's substantial number of clinical studies on minoxidil's efficacy and safety also make it an attractive region for industry players[1][4].

Financial Trajectory

Market Size and Growth

The global minoxidil market, which includes ROGAINE, is projected to grow from USD 1.2 billion in 2023 to USD 1.89 billion by 2033, at a Compound Annual Growth Rate (CAGR) of 4.65%[3][4].

Revenue Streams

North America and Europe are expected to be the primary revenue streams for the minoxidil market. The expanding end-user demand and adequate supply from key manufacturers in these regions will drive market expansion. The introduction of new and innovative hair care products will further contribute to the financial growth of the market[3][4].

Competitive Analysis

ROGAINE, under the ownership of Johnson & Johnson, remains a leading brand in the minoxidil market. The company's continuous innovation, such as the development of the 5% minoxidil foam, has helped maintain its market position. Other competitors in the market also focus on product innovation and strategic expansions to capture market share[2][4].

Efficacy and Patient Satisfaction

Studies have shown that the 5% minoxidil solution is highly effective in stimulating new hair growth. Patient satisfaction scores have improved significantly, with a mean score increasing from 2.9 to 4.4 over the course of treatment. However, patients and physicians sometimes have differing opinions on the efficacy, with physicians rating the treatment as good or very good more frequently than patients[5].

Side Effects and Safety

While minoxidil is generally well-tolerated, some patients experience mild side effects, mostly dermatologic. These side effects are reported by approximately 3.9% of patients, but none are classified as serious[5].

Future Outlook

The minoxidil market, including ROGAINE, is poised for continued growth driven by increasing demand for hair loss treatments, innovative product developments, and effective marketing strategies. As the market expands, it is expected that new formulations and delivery methods will be introduced, further enhancing the product's efficacy and user experience.

Key Takeaways

  • Growing Demand: High prevalence of androgenetic alopecia drives the demand for minoxidil.
  • Innovations: Continuous product innovations, such as higher concentration solutions and foams, enhance market prospects.
  • Regional Growth: North America and Europe are key regions driving market growth.
  • Financial Growth: The global minoxidil market is expected to reach USD 1.89 billion by 2033.
  • Competitive Landscape: ROGAINE remains a leading brand with continuous innovation.
  • Efficacy and Safety: The 5% minoxidil solution is highly effective with minimal side effects.

FAQs

1. What is the primary use of ROGAINE?

ROGAINE, or minoxidil, is primarily used to treat hereditary hair loss by promoting hair regrowth.

2. What are the different forms of ROGAINE available?

ROGAINE is available in 2% and 5% minoxidil solutions, as well as in a 5% minoxidil foam formulation for both men and women.

3. Which regions are driving the growth of the minoxidil market?

North America and Europe are the key regions driving the growth of the minoxidil market, with North America holding the largest share and Europe expected to grow at the fastest CAGR.

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

The global minoxidil market is expected to reach USD 1.89 billion by 2033, growing at a CAGR of 4.65% from 2023 to 2033.

5. What are the common side effects of minoxidil?

Common side effects of minoxidil are mostly dermatologic and reported by approximately 3.9% of patients, but none are classified as serious.

Cited Sources:

  1. Biospace: Minoxidil Market: Key Trends - Global Industry Analysis [2020-2030]
  2. ROGAINE: Our Story | ROGAINEĀ®
  3. Spherical Insights: Global Minoxidil Market Size, Analysis, Report Forecasts To 2033
  4. Spherical Insights: Global Minoxidil Market Size, Share, Forecasts To 2033
  5. ISHRS: EFFECTIVENESS OF 5% MINOXIDIL IN TREATING MALE PATTERN HAIR LOSS

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