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, Sun Pharma Canada, 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 sixteen 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:	16
Tradenames:	6
Applicants:	16
NDAs:	28
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	89
Patent Applications:	7,067
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
Badr University	PHASE4
Khyber Teaching Hospital	PHASE4
Indonesia Medical Education and Research Institute	PHASE3

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			Y
Call Inc	ADAPALENE	adapalene	SOLUTION;TOPICAL	203981-001	Sep 23, 2016	AB	RX	No	No
Padagis Israel	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	212464-001	May 31, 2022	AB	RX	No	No
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	AB	RX	Yes	Yes
Sun Pharma Canada	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	209148-001	Oct 17, 2018	AB	RX	No	No
Sun Pharma Canada	ADAPALENE	adapalene	GEL;TOPICAL	215940-001	Jan 14, 2022		OTC	No	No

Expired US Patents for ADAPALENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996

International Patents for ADAPALENE

Country	Patent Number	Title	Estimated Expiration
Japan	2012184258	COMPOSITION CONTAINING AT LEAST ONE DERIVATIVE OF NAPHTHOIC ACID AND AT LEAST ONE POLYURETHANE POLYMER TYPE COMPOUND OR DERIVATIVE THEREOF, PREPARATION METHOD, AND USE OF THE SAME
France	2890861	COMPOSITIONS COMPRENANT AU MOINS UN DERIVE DE L'ACIDE NAPHTOIQUE ET AU MOINS UN COMPOSE DE TYPE POLYMERES DE POLYURETHANES OU DES DERIVES DE CELUI-CI, LEURS PROCEDE DE PREPARATION, ET LEUR UTILISATION (Composition, useful to treat and/or prevent e.g. dermatological diseases, acne necrotic, acne neonatorum, comprises naphthoic acid derivative and polyurethane type polymer)
China	1642538	Use of adapalene for the treatment of dermatological disorders
China	101262862	Composition comprising at least one naphthoic acid derivative and at least one compound of polyurethane polymer type or derivatives thereof, preparation processes therefor and uses thereof
Cyprus	1108868
Canada	2478237	EMPLOI D'ADAPALENE POUR LE TRAITEMENT DE TROUBLES DERMATOLOGIQUES (USE OF ADAPALENE FOR THE TREATMENT OF DERMATOLOGICAL DISORDERS)

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

Market Dynamics and Financial Trajectory for ADAPALENE

Last updated: July 27, 2025

Introduction

Adapalene, a third-generation topical retinoid, has cemented its role in dermatological therapy, particularly for acne vulgaris. Originally developed by Galderma, adapalene’s distinctive pharmacological profile and its favorable safety profile have driven its widespread adoption. This article analyzes the current market landscape, key drivers, competitive forces, regulatory considerations, and projected financial trajectory for adapalene over the coming years.

Pharmacological Profile and Clinical Applications

Adapalene functions primarily as a selective agonist of retinoic acid receptor (RAR) subtypes, modulating cellular differentiation and keratinization. Since FDA approval in 1996, its primary indication remains moderate to severe acne vulgaris (both inflammatory and comedonal). Its efficacy surpasses that of earlier agents such as tretinoin, mainly due to improved tolerability and stability against degradation caused by light and oxygen. Additionally, its role in preventing post-inflammatory hyperpigmentation has expanded its appeal among dermatologists.

Market Landscape and Competitive Position

Historical Growth and Market Segments

The global adapalene market experienced consistent growth from 2010 onwards, driven by increasing acne prevalence among adolescents and young adults. The rise in awareness about skin health, coupled with the adoption of topical retinoids as first-line therapy, cemented adapalene's position. Estimated global sales surpassed USD 400 million by 2022, with a CAGR of approximately 4-5% during the prior decade [1].

Major Players and Competitive Dynamics

Galderma remains the dominant provider, offering differentiation through its formulations such as Differin Gel (adapalene 0.1%), which was reclassified as over-the-counter (OTC) in several markets, notably the U.S. in 2016. Key competitors include:

• Bausch Health with products like Tazorac, though primarily focusing on other retinoids.
• Generic manufacturers offering lower-cost alternatives since patent expirations around 2016.

The OTC switch significantly expanded adapalene’s consumer base, shifting a substantial share from prescription to OTC sales, thereby increasing accessibility and volume.

Emerging Market Opportunities

Developing regions like Asia-Pacific exhibit robust growth potential, fueled by rising disposable incomes, urbanization, and awareness of acne treatment options. Governments’ initiatives to improve drug affordability and distribution have also favored increased penetration of adapalene.

Digital and Direct-to-Consumer Trends

Digital marketing strategies and online pharmacies have facilitated direct-to-consumer sales, challenging traditional pharmacy channels. Teledermatology platforms promote adherence and consultation, further expanding market reach.

Regulatory and Patent Landscape

Regulatory Approvals

Post-2016, the OTC approval of adapalene in the U.S. marked a paradigm shift. Regulatory agencies continue to evaluate formulations tailored for specific populations (e.g., adolescents, sensitive skin). Similar approvals in Europe, Japan, and emerging markets are ongoing but vary in scope and timing.

Patent Expirations and Generic Entry

While the initial patent for Differin gel expired in 2016, patent protection remains in some jurisdictions for formulation-specific patents or combination products. Generics entered rapidly post-expiry, intensifying price competition but also expanding market volume due to lower entry barriers [2].

Pipeline and Formulation Innovations

Research into combination therapies (adapalene with benzoyl peroxide or antibiotics) aims to enhance efficacy and reduce resistance. Novel formulations—such as microsphere-based or gel-foam systems—seek to optimize drug delivery and tolerability, holding potential for premium pricing.

Financial Trajectory and Future Outlook

Market Projections

The adapalene market projection indicates a steady CAGR of around 4-6% through 2030, driven by:

• Broadened OTC availability.
• New formulations targeting specific demographics.
• Expansion into emerging markets.

By 2030, global sales could approach USD 700-800 million, considering compounded growth factors and market expansion [3].

Revenue Drivers

• Increased accessibility via OTC channels.
• Brand loyalty, with established formulations maintaining consumer trust.
• Pipeline innovations that command premium pricing.
• Integrated skincare products embedded with adapalene for multifaceted dermatological benefits.

Market Challenges

• Generic competition exerts downward pressure on prices.
• Regulatory hurdles in different jurisdictions may delay new formulations.
• Adherence issues due to potential irritancy; innovations in formulation are vital to mitigate this.
• Emergence of alternative therapies such as biologics for severe cases.

Strategic Implications for Stakeholders

Pharmaceutical companies should focus on:

• Accelerating pipeline development of combination and innovative formulations.
• Expanding licensing agreements in emerging markets.
• Leveraging digital platforms for patient education and direct sales.
• Maintaining a robust cost-structure to compete against generics.

Clinicians should prioritize adherence strategies and personalized treatment plans to maximize efficacy and minimize side effects, solidifying adapalene's position as a mainstay in acne management.

Key Takeaways

• Dominance and Evolution: Galderma’s adapalene maintains dominance in the acne treatment market, bolstered by its OTC status and improved formulations.
• Market Expansion: Emerging markets represent significant growth avenues, with increasing adoption driven by healthcare infrastructure improvements.
• Competitive Landscape: Patent expirations have introduced a wave of generics, fostering price competition but also emphasizing the need for value-added innovations.
• Regulatory Trends: Ongoing approvals and reformulations will influence market access and revenue streams.
• Future Growth Drivers: Pipeline innovations, digital marketing, and strategic collaborations are crucial to capturing future market share.

Conclusion

Adapalene’s market trajectory is poised for moderate but sustained growth, driven by expanding global dermatological needs and innovation within formulations. While generic competition challenges profitability, strategic investments in pipeline development and market penetration—particularly in emerging economies—offer promising avenues for revenue enhancement. The continued evolution of regulatory policies, consumer preferences, and technological advancements will shape adapalene’s financial performance over the next decade.

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FAQs

1. How has the OTC availability of adapalene impacted its market share?
The OTC switch in 2016 significantly increased accessibility, enabling over-the-counter sales and expanding consumer reach. This shift has transitioned some of the prescription market volume into retail channels, fostering broader adoption and stable revenue streams.

2. What are the main competitive threats facing adapalene currently?
The primary threats are from low-cost generics post-patent expiration, emerging combination therapies, and alternative acne treatments such as oral medications and biologics for severe cases.

3. How is clinical innovation influencing adapalene’s market?
Novel formulations aiming to enhance tolerability and efficacy are critical. Innovations like microsphere delivery systems and combination products with benzoyl peroxide are permits to command higher prices and improve patient adherence.

4. What is the outlook for adapalene in emerging markets?
These markets offer high growth potential due to increasing skin health awareness, urbanization, and rising disposable incomes. Strategic local partnerships and affordability initiatives are key to capturing market share.

5. Will patent expirations severely impact future revenues?
While patent expirations have led to price competition, continued innovation, strategic branding, and expansion into new markets can offset revenue declines and sustain growth trajectories.

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References

[1] MarketResearch.com. “Global Acne Market Report 2022-2030.”

[2] Wu, S., et al. "Impact of Patent Expirations on Topical Retinoid Market Dynamics." Journal of Dermatological Science, 2021.

[3] Future Market Insights. “Adapalene Market Forecast 2023-2030.”