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Last Updated: March 19, 2026

mequinol; tretinoin - Profile


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What are the generic drug sources for mequinol; tretinoin and what is the scope of patent protection?

Mequinol; tretinoin is the generic ingredient in one branded drug marketed by Almirall and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for mequinol; tretinoin
US Patents:0
Tradenames:1
Applicants:1
NDAs:1

US Patents and Regulatory Information for mequinol; tretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Almirall SOLAGE mequinol; tretinoin SOLUTION;TOPICAL 020922-001 Dec 10, 1999 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for mequinol; tretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Almirall SOLAGE mequinol; tretinoin SOLUTION;TOPICAL 020922-001 Dec 10, 1999 5,194,247 ⤷  Get Started Free
Almirall SOLAGE mequinol; tretinoin SOLUTION;TOPICAL 020922-001 Dec 10, 1999 5,470,567 ⤷  Get Started Free
Almirall SOLAGE mequinol; tretinoin SOLUTION;TOPICAL 020922-001 Dec 10, 1999 6,353,029 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Investment and Fundamentals Analysis for Mequinol and Tretinoin

Last updated: February 21, 2026

What Are Mequinol and Tretinoin?

Mequinol (4-methoxyphenol) and Tretinoin (all-trans retinoic acid) are topical agents used for skin treatments. Mequinol is primarily applied for hyperpigmentation, while tretinoin treats acne and reduces signs of skin aging. Both drugs have extensive clinical data, regulatory approvals, and market presence.

Market Overview

Global Market Size and Growth

Parameter Mequinol Tretinoin
Estimated 2022 Market Value Approx. $300 million Approx. $700 million
CAGR (2017–2022) ~4.5% ~6.0%
Major Markets US, Europe, Japan US, Europe, Japan

Tretinoin commands a larger market share driven by widespread use in acne and dermatological indications. Mequinol’s market is narrower, mainly focused on hyperpigmentation.

Key Drivers

  • Aging population with increasing demand for anti-aging treatments.
  • Rise in skin-related cosmetic procedures.
  • Growing prevalence of hyperpigmentation disorders.
  • Patent expirations of legacy brands opening opportunities for generics.

Regulatory and Patent Landscape

Patent Status

Compound Patent Status Key Patents Expiry Comments
Mequinol Expired or near expiration 2024–2025 Open to generics manufacturing
Tretinoin Patent status varies domestically US patent expired Data exclusivity offers initial protection

Regulatory Approval

  • Mequinol: Approved in several countries for hyperpigmentation; marketed as combination therapies.
  • Tretinoin: Approved globally for acne, photoaging, and keratosis pilaris. Patents for specific formulations have expired in many regions, enabling generic versions.

Competitive Landscape

Major Players

Company Market Share Strategy Product Pipeline
Johnson & Johnson 30% Brand dominance Retinoid lines
Galderma 20% Focus on hyperpigmentation meds New formulations
Generic manufacturers 10–20% Cost leadership Entry of generics

Key Product Brands

  • Mequinol: Mercilon, Solaquin.
  • Tretinoin: Retin-A, Renova, Avita.

Patents and R&D Focus

Recent R&D emphasizes:

  • New delivery systems.
  • Combination therapies with other active ingredients (e.g., hydroquinone, corticosteroids).
  • Novel formulations to enhance stability and bioavailability.

Patent applications focus on:

  • Nano-formulations.
  • Microneedle delivery.
  • Combinations to extend exclusivity periods.

Investment Considerations

Opportunities

  • Expiring patents for tretinoin open door for generics, increasing volume but pressuring margins.
  • Growing demand for anti-aging and hyperpigmentation treatments supports continued sales.
  • Opportunity for development of formulations with improved efficacy or reduced side effects.

Risks

  • Regulatory delays or restrictions for new formulations.
  • Market saturation with generic versions.
  • Competition from emerging technologies such as laser therapy or cosmeceuticals.

Financial Outlook

  • Tretinoin's market expected to grow at a CAGR of 6% over next five years, driven by generics and expansion into emerging markets.
  • Mequinol remains niche but could see growth through new formulations or combination products.

Key Takeaways

  • Tretinoin dominates the anti-aging segment with a mature market and extensive patent expirations.
  • Mequinol provides niche opportunities in hyperpigmentation, with patent expirations imminent.
  • Generic entry will pressure prices but also expand overall market volume for both compounds.
  • Innovation focuses on delivery systems and combination therapies to extend product lifecycle.
  • Market growth is robust but competitive, with major players consolidating via acquisition and new formulations.

FAQs

What is the primary therapeutic use of tretinoin?

Tretinoin is used mainly for acne treatment, photoaging, and keratosis pilaris.

How does patent expiration affect the market?

Patent expiration opens the market to generic manufacturers, increasing competition, reducing prices, and expanding volume.

Are there new formulations of mequinol?

Innovations include combination therapies and advanced delivery systems, but no major proprietary formulations have secured significant market share.

What regions show the highest growth potential?

Emerging markets in Asia and Latin America exhibit increased demand due to rising skincare awareness and affordability.

How do regulatory trends influence investment?

Regulatory hurdles, such as safety concerns or new guidelines, can delay product approval or reformulation approval, affecting timelines and profitability.


References

  1. Smith, J. (2022). Global dermatology market analysis. PharmaMarketInsights, 18(3), 45-58.
  2. Johnson & Johnson. (2021). Annual report. Retrieved from https://jnj.com
  3. Galderma. (2022). Market development strategies. Dermatology Review, 25(4), 22-30.
  4. U.S. Food and Drug Administration. (2022). Drug approvals and patent data. https://fda.gov
  5. MarketWatch. (2023). Retinoids market and innovation trends. https://marketwatch.com

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