ADAPALENE; BENZOYL PEROXIDE - Generic Drug Details

What are the generic sources for adapalene; benzoyl peroxide and what is the scope of freedom to operate?

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, Sun Pharma Canada, 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.

Thirteen 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:	13
Clinical Trials:	43
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
Sun Pharmaceutical Industries, Inc.	PHASE1
University of Oklahoma	Phase 3
delta medical promotions ag	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
Padagis Israel	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	205033-001	Jan 23, 2018	AB	RX	No	No
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes			Y
Actavis Mid Atlantic	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	203790-001	Sep 30, 2015		DISCN	No	No

Expired US Patents for ADAPALENE; BENZOYL PEROXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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
Cyprus	1114473
Russian Federation	2012136952	КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
European Patent Office	2046318

Supplementary Protection Certificates for ADAPALENE; BENZOYL PEROXIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	SZ 31/2008	Austria		PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
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	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 and Benzoyl Peroxide Combination

Last updated: July 28, 2025

Introduction

The combination of adapalene and benzoyl peroxide (BPO) represents a significant segment within the topical acne treatment landscape. This duo has gained prominence due to its demonstrated efficacy, favorable safety profile, and positioning as a first-line therapy for acne vulgaris. Understanding the market dynamics and financial trajectory for this combination is crucial for pharmaceutical companies, investors, and healthcare stakeholders aiming to navigate current trends and forecast future growth.

Market Overview and Key Drivers

Global Prevalence of Acne and Market Demand

Acne vulgaris remains one of the most common dermatological conditions globally, affecting up to 9.4% of the population worldwide, with prevalence peaking in adolescents and young adults. The persistent prevalence sustains consistent demand for effective topical therapies.

According to Global Data, the dermatology drugs market was valued at approximately USD 35 billion in 2022, with acne therapeutics accounting for a significant segment. The rising incidence of adult acne and the demand for over-the-counter (OTC) treatments further bolster market growth.

Therapeutic Efficacy of Adapalene-Benzoyl Peroxide Formulation

The fixed-dose combination of adapalene (a third-generation topical retinoid) and benzoyl peroxide delivers a synergistic approach: adapalene reduces inflammation and normalizes follicular keratinization, while BPO exerts antimicrobial activity against Propionibacterium acnes. This dual mechanism improves patient outcomes and reduces the likelihood of resistance.

Notably, brands such as Epiduo (AbbVie), TactuPump (Galderma), and Ziana (Taro Pharmaceuticals) have established the combination’s clinical efficacy, reinforcing its position as a preferred topical therapy for mild to moderate acne.

Regulatory and Patent Landscape

The landmark approval of Epiduo in 2008 marked a pivotal moment, setting the stage for widespread adoption. Patent protections, particularly those covering formulation specifics and delivery mechanisms, have historically provided market exclusivity, fostering revenue generation. However, patent expirations are imminent or have occurred for several formulations, opening pathways for generic entry.

Market Dynamics and Competitive Landscape

Market Players and Innovation

Leading pharmaceutical companies like Galderma, Taro Pharmaceuticals, and AbbVie dominate the market with their respective formulations. The push toward improved delivery systems—such as pump devices and controlled-release formulations—aims to enhance patient adherence and outcomes.

Emerging competitors focus on natural, OTC, and combination products, providing alternative options for consumers and contributing to increased market fragmentation.

Pricing Strategies and Reimbursement

Pricing strategies significantly influence market penetration. Branded formulations often command premium prices, especially in regions with insurance coverage, while generics tend to be more affordable, expanding access. Reimbursement policies vary worldwide and impact overall sales volumes.

Market Penetration and Geographic Expansion

North America remains the largest market, driven by high acne prevalence, established healthcare infrastructure, and high consumer awareness. Europe follows, with steady growth fueled by dermatology awareness campaigns.

Emerging markets in Asia-Pacific, Latin America, and the Middle East exhibit expanding demand due to increasing urbanization, rising disposable income, and greater awareness of skin health. Local manufacturing and regulatory approvals are accelerating entry in these regions.

Financial Trajectory and Growth Projections

Revenue Trends and Key Factors

The revenue generated by adapalene and benzoyl peroxide combinations is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years (2023–2028), according to industry analyses [1]. Market expansion, patent expirations impacting branded products, and technological innovations underpin this projection.

The introduction of generic formulations has further intensified price competition, pressuring branded product margins but expanding market volume. Strategic alliances, licensing agreements, and co-marketing partnerships continue to influence financial trajectories.

Impact of Patent Expirations

Patents for pioneering formulations are nearing expiry in key markets, with generic competitors expected to penetrate the market rapidly. This switch from branded to generic products typically results in revenue compression but can also catalyze overall market growth as lower prices improve accessibility.

Pipeline and Future Innovations

Research efforts are focused on enhancing drug delivery systems, reducing application frequency, and minimizing side effects. Novel formulations incorporating nanotechnology or alternative retinoids aim to sustain revenue streams and extend market exclusivity, influencing future financial trajectories favorably.

Regulatory Environment and Market Access

Differing regulatory pathways worldwide affect market penetration timelines and sales forecasts. Accelerated approval processes in regions like the U.S. and Europe enable quicker access, while varying reimbursement policies can either hinder or facilitate commercialization.

Market access strategies, including demonstrating comparative effectiveness and safety, remain vital for sustaining growth, especially as generic competition mounts.

Conclusion

The market for adapalene and benzoyl peroxide combinations is poised for steady growth driven by high prevalence, proven efficacy, and expanding geographic reach. However, patent expirations and increasing generic competition present both challenges and opportunities. Innovations in formulation, strategic collaborations, and adaptive pricing strategies are critical for maintaining financial strength in a dynamic landscape transitioning from branded dominance to competitive parity with generics.

---

Key Takeaways

• Consistent Demand: Acne's global prevalence ensures ongoing demand for adaptable topical therapies like adapalene and BPO combinations.
• Patent Dynamics: Patent expirations are set to increase generic market share, pressuring branded product revenues but expanding overall market volume.
• Innovation Focus: Advances in drug delivery systems and new formulations are essential for sustaining competitive advantage and revenue streams.
• Emerging Markets: Geographic expansion into Asia-Pacific and Latin America offers significant growth opportunities.
• Strategic Positioning: Collaborations, pricing strategies, and regulatory navigation will determine market share and profitability trajectories.

---

FAQs

1. When are key patents for adapalene-benzoyl peroxide formulations expiring?
Most patents for pioneering formulations are expiring between 2023 and 2025, paving the way for generic competitors to enter markets globally.

2. How do generics influence the financial outlook of the adapalene-BPO market?
Generic entries typically lead to steeper price reductions but increase overall volume, resulting in revenue shifts from branded to generic products, with the total market size often expanding.

3. What innovations are emerging in topical acne therapies?
Research focuses on nanotechnology-based delivery, reduced application frequency, and combination therapies that enhance efficacy and compliance.

4. Which regions present the most growth potential for adapalene-benzoyl peroxide products?
Asia-Pacific, Latin America, and the Middle East are rapidly expanding markets driven by increasing acne prevalence, rising disposable incomes, and growing healthcare infrastructure.

5. How are regulatory policies impacting market expansion?
Regulatory agencies like the FDA and EMA facilitate faster approvals, while reimbursement policies influence market access and sales volume, especially in developed markets.

---

References
[1] MarketWatch. “Topical Acne Market Analysis & Trends,” 2022.