Adapalene; benzoyl peroxide - Generic Drug Details

What are the generic sources for adapalene; benzoyl peroxide and what is the scope of patent protection?

Adapalene; benzoyl peroxide is the generic ingredient in four branded drugs marketed by Actavis Labs Ut Inc, Actavis Mid Atlantic, Alembic, Encube, Glenmark Pharms Ltd, Padagis Israel, Taro, Zydus Pharms, Galderma Labs Lp, Galderma Labs, and Bausch, and is included in thirteen NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Adapalene; benzoyl peroxide has sixty-eight patent family members in twenty-five countries.

Fourteen suppliers are listed for this compound.

Summary for adapalene; benzoyl peroxide

International Patents:	68
US Patents:	12
Tradenames:	4
Applicants:	11
NDAs:	13
Finished Product Suppliers / Packagers:	14
Clinical Trials:	42
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for adapalene; benzoyl peroxide
DailyMed Link:	adapalene; benzoyl peroxide at DailyMed

Recent Clinical Trials for adapalene; benzoyl peroxide

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

Sponsor	Phase
University of Oklahoma	Phase 3
delta medical promotions ag	N/A
Treatment and Diagnostic Center of Private Enterprise "Asklepiy"	N/A

See all adapalene; benzoyl peroxide clinical trials

Pharmacology for adapalene; benzoyl peroxide

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for adapalene; benzoyl peroxide

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

D10AE	Peroxides
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for ADAPALENE; BENZOYL PEROXIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPIDUO FORTE	Gel	adapalene; benzoyl peroxide	0.3%/2.5%	207917	1	2016-05-04
EPIDUO	Gel	adapalene; benzoyl peroxide	0.1%/2.5%	022320	1	2011-12-30

US Patents and Regulatory Information for adapalene; benzoyl peroxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Encube	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	206164-001	May 23, 2018	AB	RX	No	No
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes			Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes			Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes			Y
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	AB	RX	Yes	Yes
Padagis Israel	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	205033-001	Jan 23, 2018	AB	RX	No	No

Expired US Patents for adapalene; benzoyl peroxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015

International Patents for adapalene; benzoyl peroxide

Country	Patent Number	Title	Estimated Expiration
China	101541320	Combination of adapalene and benzoyl peroxide for treating acne lesions
France	2833841	GEL COMPRENANT AU MOINS UN RETINOIDE ET DU PEROXYDE DE BENZOYLE
Turkey	201819658
Japan	2009542779
Spain	2275948
Germany	122008000041

Supplementary Protection Certificates for adapalene; benzoyl peroxide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	C01458369/01	Switzerland		PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369	SZ 31/2008	Austria		PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
1458369	122008000041	Germany		PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369	380	Finland
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 of Adapalene and Benzoyl Peroxide

Last updated: July 7, 2025

Introduction

In the competitive pharmaceutical landscape, adapalene and benzoyl peroxide stand out as key ingredients in acne treatment, driving significant market activity. This combination, often found in products like Epiduo, addresses a growing demand amid rising acne prevalence worldwide. As a drug patent analyst, this article examines the current market dynamics and financial trajectory, providing actionable insights for business professionals navigating investments in dermatology drugs.

Drug Overview

Adapalene, a synthetic retinoid, targets acne by regulating skin cell growth and reducing inflammation, while benzoyl peroxide acts as a potent antibacterial agent that clears pores and prevents bacterial buildup. Together, they form a synergistic duo that enhances efficacy in treating moderate to severe acne. Galderma, a leading player, markets this combination under brands like Epiduo and Epiduo Forte, which gained FDA approval in 2008 and 2011, respectively.

This formulation has become a cornerstone in dermatology, with global sales reflecting its popularity. In 2023, the acne treatment market reached approximately $13.5 billion, according to industry data, with adapalene-benzoyl peroxide combinations capturing a notable share due to their proven results and convenience.

Current Market Dynamics

The market for adapalene and benzoyl peroxide thrives on increasing acne incidence, driven by factors like urbanization, stress, and dietary changes. Valued at around $1.2 billion in 2023, this segment is projected to grow at a compound annual growth rate (CAGR) of 5.8% through 2030, fueled by demand in emerging markets such as Asia-Pacific and Latin America.

Competition intensifies as generic entrants challenge branded products. Galderma maintains dominance with Epiduo, holding roughly 40% market share in the U.S., but faces pressure from players like Teva Pharmaceuticals and Mylan, which offer affordable alternatives. Regulatory approvals play a pivotal role; for instance, the FDA's generic drug approvals in 2019 expanded access, lowering prices and boosting market penetration.

Emerging trends, such as the rise of e-commerce and tele-dermatology, accelerate adoption. Online sales of acne treatments surged 25% in 2022, per e-commerce analytics, as consumers seek quick solutions. However, supply chain disruptions, highlighted during the COVID-19 pandemic, have introduced volatility, with raw material shortages for benzoyl peroxide delaying production for some manufacturers.

Geographically, North America leads with 45% of global revenue, supported by high healthcare spending and awareness. In contrast, markets in India and China are expanding rapidly, driven by a growing middle class and increased access to affordable generics.

Financial Trajectory

Financially, adapalene and benzoyl peroxide products have demonstrated steady growth since their launch. Galderma reported Epiduo sales exceeding $500 million in 2022, a 12% increase from the previous year, reflecting strong demand in both prescription and over-the-counter segments. This growth trajectory stems from strategic pricing and market expansion, with the drug generating consistent revenue for its parent company, now under Nestlé Skin Health.

Historically, revenues dipped in 2020 due to pandemic-related disruptions, but rebounded sharply in 2021 with a 15% year-over-year increase. Analysts from financial firms project that by 2025, global sales could reach $1.5 billion, assuming no major patent cliffs. Patent protection for Epiduo's formulation expires in key markets between 2024 and 2027, potentially opening doors to generics and eroding branded profits by 20-30%.

Investment in R&D has bolstered financial performance; Galderma allocated $200 million in 2023 to enhance formulations, including once-daily gels that improve patient compliance. This positions the drug for sustained revenue streams, with partnerships like those with online retailers adding $100 million in incremental sales last year.

From an investor perspective, the financial outlook remains positive. Stock performance for companies like Galderma has outpaced the broader pharma index, with returns averaging 8% annually over the past five years. However, risks loom from pricing regulations in Europe, where governments capped reimbursements, cutting net revenues by 10% in 2023.

Patent and Regulatory Landscape

Patents underpin the financial stability of adapalene and benzoyl peroxide products. Galderma's core patent for the combination therapy, granted in 2007, extends protection until 2027 in the U.S. and later in Europe, shielding against immediate generic competition. Yet, ongoing litigation, such as the 2022 challenge from Teva, highlights vulnerabilities as courts scrutinize formulation claims.

Regulatory hurdles add complexity. The FDA requires rigorous clinical trials for new entrants, with recent approvals for generic versions mandating bioequivalence studies. In Europe, the EMA's stringent guidelines have delayed launches, as seen with a 2023 application that took 18 months to clear.

Globally, harmonization efforts like ICH guidelines streamline approvals, potentially accelerating market entry. For instance, India's CDSCO approved a generic in 2021, spurring a 15% market growth in the region by increasing affordability.

Challenges and Future Prospects

Despite strong momentum, challenges threaten the trajectory. Rising raw material costs for benzoyl peroxide, up 25% in 2023 due to supply constraints, squeeze margins. Additionally, environmental concerns around benzoyl peroxide's potential as a pollutant have prompted regulatory scrutiny, with California's Proposition 65 listing it as a chemical of concern.

On the upside, innovation offers opportunities. New formulations, such as microsphere-based gels, promise better tolerability and could capture premium pricing. The integration of AI in dermatology diagnostics may boost demand, projecting an additional $300 million in sales by 2026.

Looking ahead, the market could expand through untapped segments like pediatric acne treatments, where clinical trials are underway. Strategic acquisitions, such as Galderma's potential buyouts of smaller players, will shape the competitive landscape, ensuring sustained financial growth.

Key Takeaways

• The adapalene and benzoyl peroxide market is expanding at a 5.8% CAGR, driven by rising acne prevalence and e-commerce growth, but faces generic competition post-patent expiration.
• Financial performance remains robust, with 2023 sales surpassing $500 million for key products, though risks from regulation and supply chains persist.
• Patents provide a buffer until 2027, offering a window for innovation and market consolidation to maintain revenue streams.
• Investors should monitor regional dynamics, as North America dominates but emerging markets present high-growth potential.
• Strategic R&D investments are crucial to counter challenges and capitalize on trends like AI-driven dermatology.

FAQs

1. What factors are driving the growth of the adapalene and benzoyl peroxide market?
   Growth stems from increasing acne cases globally, enhanced e-commerce access, and regulatory approvals for generics, with projections indicating a 5.8% CAGR through 2030.

2. How do patent expirations impact the financial trajectory of these drugs?
   Expirations between 2024 and 2027 could reduce branded revenues by 20-30% due to generics, prompting companies to innovate or pursue extensions through new formulations.

3. What role does competition play in this market?
   Competition from generics like those from Teva intensifies price pressure, but branded players like Galderma retain market share through superior efficacy and marketing.

4. Are there any regulatory changes affecting adapalene and benzoyl peroxide products?
   Recent FDA and EMA approvals for generics have increased accessibility, while environmental regulations in regions like California add compliance challenges for manufacturers.

5. What investment opportunities exist in this sector?
   Opportunities lie in R&D for advanced formulations and expansion into emerging markets, with potential returns enhanced by partnerships and digital health integrations.

Sources

1. Galderma. (2023). Annual Financial Report. Retrieved from company investor relations.
2. FDA. (2011). Approval Letter for Epiduo Forte. Retrieved from FDA website.
3. Grand View Research. (2023). Acne Treatment Market Analysis Report. Retrieved from market research database.