ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - Generic Drug Details

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

Adapalene; benzoyl peroxide; clindamycin phosphate is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Adapalene; benzoyl peroxide; clindamycin phosphate has thirty-one patent family members in fifteen countries.

One supplier is listed for this compound.

Summary for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

International Patents:	31
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
DailyMed Link:	ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Constraining patent/regulatory exclusivity:

8,288,434

Dosage:

GEL;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

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

Sponsor	Phase
Sun Pharmaceutical Industries, Inc.	PHASE1
GlaxoSmithKline	Phase 4
Stiefel, a GSK Company	Phase 4

See all ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE clinical trials

Pharmacology for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Drug Class	Lincosamide Antibacterial Retinoid
Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Anatomical Therapeutic Chemical (ATC) Classes for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

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

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

G01AA	Antibiotics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01FF	Lincosamides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	12,128,059		Y
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	10,624,918
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes

International Patents for ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2493847	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ (PHARMACEUTICAL FORMULATIONS FOR LOCAL APPLICATION CONTAINING LOW CONCENTRATIONS OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND WATER-MISCIBLE ORGANIC SOLVENT)
Russian Federation	2013122395	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ
South Korea	20110014651	TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT

Market Dynamics and Financial Trajectory for Adapalene, Benzoyl Peroxide, and Clindamycin Phosphate

Last updated: November 1, 2025

Introduction

The dermatological pharmaceutical landscape has experienced significant transformation driven by the evolving prevalence of acne vulgaris and advances in topical therapies. Among the leading formulations are combinations of adapalene, benzoyl peroxide, and clindamycin phosphate—collectively targeting inflammatory and non-inflammatory acne. This analysis examines the current market dynamics and forecasts the financial trajectory for these drugs, considering key drivers, competitive elements, regulatory shifts, and emerging trends.

Market Overview

Adapalene, benzoyl peroxide, and clindamycin phosphate are cornerstone agents in dermatology, particularly for moderate to severe acne. Their combination formulations optimize antimicrobial, anti-inflammatory, and keratolytic actions, consolidating their market prominence.

Global dermatology drug sales, valued at approximately USD 45 billion in 2022, are projected to grow at a CAGR of 4.5% over the next five years. This growth is primarily driven by rising acne prevalence among adolescents and adults, heightened awareness, and expanded access to dermatological care [1].

In particular, combination therapies involving adapalene, benzoyl peroxide, and clindamycin are among the fastest-growing segments, owing to their synergistic efficacy and improved patient compliance.

Market Dynamics

Drivers

Increasing Acne Prevalence and Awareness

Acne affects approximately 85% of adolescents and a significant proportion of adults, with estimates indicating over 50 million cases in the U.S. alone [2]. The increasing recognition of acne's psychosocial impact drives demand for effective, long-term treatments.

Preference for Topical Therapies

Patients and clinicians favor topical over systemic therapies due to reduced systemic side effects. The enhanced tolerability and efficacy of combination topical formulations contribute to market growth.

Innovation and Extended Indications

Advancements such as extended-release formulations, combination patches, and novel delivery mechanisms (e.g., microneedles) foster innovation, increasing therapeutic options.

Regulatory Approvals and Patent Expiries

Patent expirations for some formulations create market opportunities for biosimilars and generics, intensifying competition but also stimulating innovation with new complex formulations.

Challenges

Patient Compliance and Tolerability

Side effects like skin irritation, dryness, and redness can hamper adherence, affecting market growth. Emphasis on developing formulations with better tolerability is critical.

Pricing and Reimbursement Policies

Cost constraints, especially in emerging markets, and variations in reimbursement policies influence patient access and drug uptake.

Regulatory Environment

Tightening regulatory standards regarding safety profiles and environmental impacts challenge ongoing development and approval of new formulations.

Competitive Landscape

The market features several key players:

• AbbVie (Clindamycin Phosphate + Benzoyl Peroxide, Epiduo), a dominant force with a substantial global footprint.
• Galderma (Adapalene + Benzoyl Peroxide, Differin and Epiduo), innovating with newer formulations and indications.
• Bausch Health and Almirall contribute generic and branded options, expanding accessibility.

Emerging players are investing in novel delivery systems to improve tolerability and compliance. Biosimilars and generics are anticipated to proliferate, especially post patent expiry, impacting pricing dynamics.

Financial Trajectory

Historical Performance

The combination formulations of adapalene, benzoyl peroxide, and clindamycin have experienced steady revenue growth, driven by their proven efficacy and expanding indications. In 2022, the global market for topical acne treatments was valued at approximately USD 3 billion, with combination therapies accounting for over 65% of sales [3].

AbbVie's Epiduo remains a top revenue generator, with global sales exceeding USD 1 billion annually. The growth momentum is reinforced by increasing prescriptions and expanding approval for new age groups and mild-to-moderate acne.

Forecasted Growth

Considering the current pipeline, patent landscapes, and emerging trends, the market for these combination drugs is projected to reach USD 4.5 billion by 2028, representing a CAGR of approximately 6%. The key contributing factors include:

• Expanding global reach, especially in Asia-Pacific and Latin America.
• Introduction of new formulations, such as overnight gels and controlled-release patches.
• Increasing adoption for off-label indications, including rosacea and psoriasis variants.

Furthermore, biosimilar entrants are expected to exert downward pressure on prices but may also enhance penetration in cost-sensitive markets.

Emerging Trends Influencing Financial Trajectory

• Personalized dermatology: Use of diagnostics to tailor treatments can optimize outcomes, influencing demand.
• Digital health integration: Mobile apps and teledermatology facilitate prescription adherence and patient engagement.
• Sustainability and environmental considerations: Eco-friendly manufacturing and packaging may impact production costs and marketing strategies.

Regulatory and Market Access Outlook

Regulatory agencies like the FDA and EMA are prioritizing safety and efficacy, with accelerated pathways for breakthrough therapies and reformulations. Reimbursement policies are becoming more sophisticated, emphasizing value-based care, which influences product positioning and pricing.

In markets like the U.S., the introduction of generic versions post patent expiry will likely reduce average selling prices by 20-30%, impacting revenue streams but increasing volume and market share.

Conclusion and Strategic Implications

The dynamic landscape of combination therapies involving adapalene, benzoyl peroxide, and clindamycin phosphate continues to evolve with technological, regulatory, and market forces. Companies that invest in innovation, emphasize patient tolerability, and navigate the complex reimbursement terrains will be well-positioned for sustainable growth.

Pharmaceutical firms should monitor patent cliffs, embrace novel delivery mechanisms, and anticipate regulatory shifts to optimize portfolio management and capitalize on emerging markets.

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Key Takeaways

• The global market for topical acne treatments, especially combination formulations, is projected to grow at a CAGR of 6%, driven by rising acne prevalence and ongoing innovation.
• Patent expiries and the rise of generics will reshape pricing strategies, creating opportunities for both established players and entrants.
• Improving patient tolerability and adherence remains a critical focus, influencing formulation development.
• Regulatory pathways increasingly favor rapid access to innovative therapies, influencing pipeline priorities.
• Expansion into emerging markets offers significant revenue potential but requires tailored strategies considering local regulatory, cultural, and economic factors.

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FAQs

Q1: What factors are driving the growth of combination formulations with adapalene, benzoyl peroxide, and clindamycin phosphate?
A1: The primary drivers include their proven efficacy in treating moderate to severe acne, improved patient compliance through simplified regimens, and expanding indications. Innovations in formulation technology and increased global awareness also contribute.

Q2: How will patent expirations influence the market for these drugs?
A2: Patent expirations will lead to increased availability of generic versions, reducing prices significantly and boosting market penetration. This creates both revenue pressures for brand-name manufacturers and opportunities for price-sensitive markets.

Q3: What are the main challenges facing the market for these topical therapies?
A3: Challenges include skin irritation and side effects impacting adherence, high development costs for novel formulations, varying reimbursement policies across regions, and regulatory hurdles concerning safety standards.

Q4: Which emerging markets hold the greatest potential for these therapies?
A4: Asia-Pacific and Latin America offer substantial growth opportunities due to rising acne prevalence, expanding healthcare access, and increasing demand for affordable treatments.

Q5: What innovations are likely to shape the future of this market?
A5: Future innovations include sustained-release formulations, combination patches, personalized treatment approaches utilizing digital diagnostics, and sustainable manufacturing practices aligning with environmental standards.

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References

[1] Market Research Future, “Global Dermatology Drugs Market,” 2022.
[2] American Academy of Dermatology Association, “Acne: Prevalence and Impact,” 2021.
[3] IQVIA, “Global Dermatology Market Analysis,” 2022.