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Last Updated: December 22, 2024

ADAPALENE Drug Patent Profile


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When do Adapalene patents expire, and when can generic versions of Adapalene launch?

Adapalene is a drug marketed by Fougera Pharms, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Pharms Inc, P And L, Taro, Call Inc, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, and Zydus Pharms. and is included in twenty NDAs.

The generic ingredient in ADAPALENE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Adapalene

A generic version of ADAPALENE was approved as adapalene; benzoyl peroxide by PADAGIS ISRAEL on January 23rd, 2018.

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Drug patent expirations by year for ADAPALENE
Drug Prices for ADAPALENE

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Drug Sales Revenue Trends for ADAPALENE

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Recent Clinical Trials for ADAPALENE

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SponsorPhase
HITEC-Institute of Medical SciencesN/A
Mansoura UniversityPhase 2
University of OklahomaPhase 3

See all ADAPALENE clinical trials

Pharmacology for ADAPALENE
Drug ClassRetinoid
Medical Subject Heading (MeSH) Categories for ADAPALENE
Paragraph IV (Patent) Challenges for ADAPALENE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DIFFERIN Topical Gel adapalene 0.30% 021753 1 2009-09-15

US Patents and Regulatory Information for ADAPALENE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera Pharms ADAPALENE adapalene CREAM;TOPICAL 090824-001 Jun 30, 2010 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Taro ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 206959-001 Jan 24, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Taro ADAPALENE adapalene GEL;TOPICAL 215940-001 Jan 14, 2022 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Encube Ethicals ADAPALENE adapalene GEL;TOPICAL 200298-001 Jun 14, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Actavis Mid Atlantic ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 203790-001 Sep 30, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 214553-001 Jun 3, 2022 AB RX 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

ADAPALENE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Adapalene Drugs

Market Overview

The adapalene drugs market is experiencing a period of significant growth and transformation, driven by several key factors. Adapalene, a topical retinoid, is widely used for the treatment of acne and other skin disorders.

Market Drivers

Increasing Incidence of Skin Disorders

The rising prevalence of skin conditions such as acne, particularly among teenagers and young adults, is a major driver of the adapalene market. According to the National Center for Biotechnology Information, approximately 15 to 30% of teenagers suffer from moderate to severe acne, which is more common in females than males[4].

Growing Awareness About Skincare

There is an increasing awareness and concern about skincare, leading to higher demand for effective treatments. This trend is particularly pronounced in urban populations where skincare routines are becoming more sophisticated[1].

Advancements in Drug Formulations

Advancements in drug formulations have enhanced the efficacy of adapalene while reducing side effects. The development of combined therapies, such as adapalene and benzoyl peroxide gels, has improved treatment outcomes and expanded the market[2].

Expansion of Over-the-Counter Availability

The transition of adapalene gel from prescription-only to over-the-counter (OTC) status in 2016 has significantly increased access and reduced costs for patients. This shift has lowered costs for patients and payers, including Medicare, and has increased the medication's accessibility[5].

Market Restraints

Potential Side Effects

Despite its effectiveness, adapalene can cause side effects such as skin irritation, dryness, and discoloration. These adverse effects can deter some users and impact market growth[4].

Competition from Other Treatments

The market faces competition from other acne treatments like benzoyl peroxide and salicylic acid, as well as alternative products such as Ziana Gel (Clindamycin Phosphate). This competition can erode market share and pricing power[4].

Generic Competition

The availability of generic adapalene products has led to price erosion, affecting the profitability of branded products. For instance, generic adapalene gel can be significantly cheaper than branded versions, such as Differin gel[4].

Regulatory and Clinical Trial Challenges

Stringent regulatory requirements and the need for extensive clinical trials pose significant hurdles for new product approvals and market entry. These challenges can slow down innovation and expansion in the market[1].

Market Opportunities

Expanding Product Lines

There is a significant opportunity to expand the product line through varied formulations such as creams, gels, and lotions. This diversification can cater to different consumer preferences and skin types[1].

Emerging Markets

Increasing penetration in emerging markets where skincare awareness is rising presents a substantial growth opportunity. Strategic partnerships with dermatologists and enhanced digital marketing efforts can help tap into these markets[1].

Combined Therapies and Advanced Delivery Systems

Developing combined therapies with other acne-fighting ingredients and reducing adverse effects through advanced delivery systems are potential areas of innovation. These advancements can improve treatment efficacy and patient compliance[1].

Market Segmentation

By Formulation

The market is segmented by formulation, including creams, gels, and others. Gels, particularly those combining adapalene with benzoyl peroxide, are popular due to their effectiveness in treating acne[4].

By Application

Adapalene products are used for various skin conditions, including acne, callus, keratosis pilaris, Darier disease, and actinic keratoses. The primary application remains the treatment of acne vulgaris[4].

By Geography

North America is expected to account for the highest market share due to the high incidence of acne and the launch of new products. Europe is anticipated to exhibit the highest CAGR due to increasing product launches and growing skincare awareness[4].

Financial Trajectory

Market Size and Growth

The adapalene drugs market is projected to experience significant growth from 2023 to 2031. The market size is expected to increase substantially, driven by the factors mentioned above. For instance, the Adapalene Benzoyl Peroxide Gel Market is anticipated to show strong growth rates during this period[2].

Revenue Projections

The revenue from adapalene products is expected to rise, with the global market valued in billions of USD. The growth will be fueled by increasing demand, new product launches, and expanding distribution channels, including e-commerce platforms[2].

Key Players and Competitive Landscape

Key players such as Galderma Laboratories LP, Teva Pharmaceutical Industries Ltd., La Roche-Posay Laboratoire Pharmaceutique, and others are driving innovation and competition in the market. These companies are focusing on strategic partnerships, new product launches, and enhancing their digital marketing efforts to maintain market share and drive growth[4].

Porter’s Five Forces Analysis

Threat of New Entrants

The threat of new entrants is moderate due to the need for significant investment in research and development, as well as the requirement for regulatory approvals. However, the potential for generic competition remains high[1].

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low due to the availability of multiple suppliers for the raw materials needed for adapalene production[1].

Bargaining Power of Buyers

The bargaining power of buyers is moderate to high, especially with the availability of generic and OTC options, which gives consumers more choices and negotiating power[1].

Threat of Substitute Products

The threat of substitute products is high due to the presence of other acne treatments like benzoyl peroxide and salicylic acid[1].

Competitive Rivalry Among Existing Competitors

The competitive rivalry is high, driven by the presence of several key players and the ongoing innovation in product formulations and delivery systems[1].

PESTLE Analysis

Political Factors

Regulatory changes and approvals play a crucial role in the adapalene market. For example, the FDA approval for OTC adapalene gel has significantly impacted market dynamics[4].

Economic Factors

Economic factors such as the cost of production, pricing strategies, and the impact of generic competition influence the market. The transition to OTC status has lowered costs for patients and payers[5].

Social Factors

Increasing awareness about skincare and the rising prevalence of skin disorders are key social factors driving the market. Urban populations are particularly influential in this trend[1].

Technological Factors

Advancements in drug formulations and delivery systems are critical technological factors. The use of combined therapies and advanced delivery systems is expected to continue driving innovation[1].

Legal Factors

Stringent regulatory requirements and the need for extensive clinical trials are significant legal factors affecting the market. Compliance with these regulations is essential for market entry and growth[1].

Environmental Factors

Environmental factors, while less direct, can influence consumer behavior and preferences. For instance, the trend towards more natural and sustainable skincare products may impact the market in the future[1].

Key Takeaways

  • The adapalene drugs market is driven by increasing skin disorder incidence, growing skincare awareness, and advancements in drug formulations.
  • The transition to OTC status has increased access and reduced costs.
  • Key challenges include potential side effects, competition from other treatments, and generic competition.
  • Opportunities lie in expanding product lines, emerging markets, and innovative delivery systems.
  • The market is segmented by formulation, application, and geography, with North America and Europe being key regions.
  • The financial trajectory indicates significant growth, with key players driving innovation and competition.

FAQs

What are the primary drivers of the adapalene drugs market?

The primary drivers include the increasing incidence of skin disorders, growing awareness about skincare, and advancements in drug formulations.

How has the OTC transition impacted the adapalene market?

The OTC transition has increased access to adapalene gel, lowered costs for patients and payers, and expanded the consumer base.

What are the main challenges facing the adapalene market?

The main challenges include potential side effects, competition from other acne treatments, generic competition, and stringent regulatory requirements.

Which regions are expected to lead the market growth?

North America is expected to account for the highest market share, while Europe is anticipated to exhibit the highest CAGR due to increasing product launches and growing skincare awareness.

Who are the key players in the adapalene market?

Key players include Galderma Laboratories LP, Teva Pharmaceutical Industries Ltd., La Roche-Posay Laboratoire Pharmaceutique, and others.

Sources

  1. 360iResearch: Adapalene Drugs Market Size & Share 2025-2030
  2. Market Research Intellect: Global Adapalene Benzoyl Peroxide Gel Market Size, Trends and ...
  3. PW Consulting: Adapalene Drugs Market
  4. Coherent Market Insights: Adapalene Products Market - Share, Size and Industry Analysis
  5. PubMed: OTC switch increased access and lowered cost of topical adapalene

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