You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 20, 2025

Adapalene; benzoyl peroxide - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
Recent Clinical Trials for adapalene; benzoyl peroxide

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

SponsorPhase
University of OklahomaPhase 3
delta medical promotions agN/A
Treatment and Diagnostic Center of Private Enterprise "Asklepiy"N/A

See all adapalene; benzoyl peroxide clinical trials

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

Expired US Patents for adapalene; benzoyl peroxide

International Patents for adapalene; benzoyl peroxide

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

Supplementary Protection Certificates for adapalene; benzoyl peroxide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369 C01458369/01 Switzerland ⤷  Try for Free PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369 SZ 31/2008 Austria ⤷  Try for Free PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
1458369 122008000041 Germany ⤷  Try for Free 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 ⤷  Try for Free PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369 380 Finland ⤷  Try for Free
1458369 SPC/GB10/005 United Kingdom ⤷  Try for Free PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.