ADAPALENE - Generic Drug Details

What are the generic drug sources for adapalene and what is the scope of patent protection?

Adapalene is the generic ingredient in six branded drugs marketed by Fougera Pharms, Galderma Labs Lp, 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, Zydus Pharms, Galderma Labs, and Bausch, and is included in twenty-eight NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Adapalene has fifty-six patent family members in twenty-two countries.

There are twelve drug master file entries for adapalene. Forty suppliers are listed for this compound.

Summary for ADAPALENE

International Patents:	56
US Patents:	15
Tradenames:	6
Applicants:	16
NDAs:	28
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	82
Drug Prices:	Drug price trends for ADAPALENE
Drug Sales Revenues:	Drug sales revenues for ADAPALENE
What excipients (inactive ingredients) are in ADAPALENE?	ADAPALENE excipients list
DailyMed Link:	ADAPALENE at DailyMed

See drug prices for ADAPALENE

See drug sales revenues for ADAPALENE

Recent Clinical Trials for ADAPALENE

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

Sponsor	Phase
HITEC-Institute of Medical Sciences	N/A
Mansoura University	Phase 2
University of Oklahoma	Phase 3

See all ADAPALENE clinical trials

Pharmacology for ADAPALENE

Drug Class

Retinoid

Medical Subject Heading (MeSH) Categories for ADAPALENE

Anti-Inflammatory Agents, Non-Steroidal

Dermatologic Agents

Anatomical Therapeutic Chemical (ATC) Classes for ADAPALENE

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

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
Galderma Labs Lp	DIFFERIN	adapalene	LOTION;TOPICAL	022502-001	Mar 17, 2010		DISCN	Yes	No	8,709,392		Y
Galderma Labs Lp	DIFFERIN	adapalene	LOTION;TOPICAL	022502-001	Mar 17, 2010		DISCN	Yes	No	8,435,502		Y
Alembic	ADAPALENE	adapalene	GEL;TOPICAL	213508-001	Jun 18, 2020	AB	RX	No	No

Expired US Patents for ADAPALENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996	4,717,720
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	7,834,060
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	RE34440

International Patents for ADAPALENE

Country	Patent Number	Title	Estimated Expiration
Cyprus	1108868
Brazil	PI0617045	composição, processo para preparar uma composição, uso de uma composição e uso cosmético de uma composição
Japan	5074401

Supplementary Protection Certificates for ADAPALENE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	08C0024	France		PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
1458369	132008901685368	Italy		PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618
1458369	SPC/GB10/005	United Kingdom		PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111

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