You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

ADAPALENE AND BENZOYL PEROXIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Adapalene And Benzoyl Peroxide patents expire, and when can generic versions of Adapalene And Benzoyl Peroxide launch?

Adapalene And Benzoyl Peroxide is a drug marketed by Actavis Labs Ut Inc, Actavis Mid Atlantic, Alembic, Encube, Glenmark Pharms Ltd, Padagis Israel, Sun Pharma Canada, and Zydus Pharms. and is included in ten NDAs.

The generic ingredient in ADAPALENE AND BENZOYL PEROXIDE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Adapalene And Benzoyl Peroxide

A generic version of ADAPALENE AND BENZOYL PEROXIDE was approved as adapalene; benzoyl peroxide by PADAGIS ISRAEL on January 23rd, 2018.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for ADAPALENE AND BENZOYL PEROXIDE?
  • What are the global sales for ADAPALENE AND BENZOYL PEROXIDE?
  • What is Average Wholesale Price for ADAPALENE AND BENZOYL PEROXIDE?
Summary for ADAPALENE AND BENZOYL PEROXIDE
US Patents:0
Applicants:8
NDAs:10
Finished Product Suppliers / Packagers: 10
Clinical Trials: 43
What excipients (inactive ingredients) are in ADAPALENE AND BENZOYL PEROXIDE?ADAPALENE AND BENZOYL PEROXIDE excipients list
DailyMed Link:ADAPALENE AND BENZOYL PEROXIDE at DailyMed
Drug patent expirations by year for ADAPALENE AND BENZOYL PEROXIDE
Recent Clinical Trials for ADAPALENE AND BENZOYL PEROXIDE

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

SponsorPhase
Sun Pharmaceutical Industries, Inc.PHASE1
University of OklahomaPhase 3
Treatment and Diagnostic Center of Private Enterprise "Asklepiy"N/A

See all ADAPALENE AND BENZOYL PEROXIDE clinical trials

Pharmacology for ADAPALENE AND BENZOYL PEROXIDE
Drug ClassRetinoid

US Patents and Regulatory Information for ADAPALENE AND BENZOYL PEROXIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Ut Inc ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 209641-001 Jun 22, 2022 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Padagis Israel ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 212464-001 May 31, 2022 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Encube ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 206164-001 May 23, 2018 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharma Canada ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 206959-001 Jan 24, 2018 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Actavis Mid Atlantic ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 203790-001 Sep 30, 2015 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ADAPALENE AND BENZOYL PEROXIDE Market Analysis and Financial Projection

Last updated: February 16, 2026

Market Overview

Adapalene and benzoyl peroxide combination products occupy a significant segment within the acne treatment market. They are established therapies primarily used for moderate to severe acne vulgaris. The combination improves efficacy over monotherapies, which supports sustained demand.

Market Size and Growth

The global acne medication market was valued at approximately $4.8 billion in 2022. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.5% through 2030, reaching roughly $8 billion. The segment specifically comprising adapalene-benzoyl peroxide formulations contributes a considerable share, driven by clinical acceptance and approval of novel formulations.

Key Market Drivers

  • Rise in acne prevalence among adolescents and young adults, especially in urban areas.
  • Increasing awareness about acne management and cosmetic impact.
  • Launch of new formulations with enhanced delivery systems.
  • Growing influence of dermatology clinical guidelines favoring combination therapies.

Regional Dynamics

North America dominates with over 40% of the market due to high prescription rates and robust healthcare infrastructure. Europe follows, influenced by tightening prescription guidelines and OTC availability of some formulations. Asia-Pacific demonstrates rapid growth fueled by increasing urbanization, rising skincare awareness, and expanding pharmaceutical penetration.

Competitive Landscape

Major players include:

  • Galderma (Dutasteride, Epiduo)
  • Johnson & Johnson (Acanya)
  • GlaxoSmithKline (Clindagel, though not a combination)
  • Organic formulations from emerging biotech firms

Galderma's Epiduo (adapalene 0.1% and benzoyl peroxide 2.5%) remains the market leader, with a significant share due to strong branding and extensive distribution.

Patent and Regulatory Status

  • The original patent for Epiduo expired in 2018 in the United States, leading to increased generic competition.
  • Some formulations have exclusivity periods until 2025-2030 depending on regional patent laws.
  • Regulatory approvals are maintained via stringent agencies (FDA, EMA), with ongoing post-market surveillance for safety.

Financial Trajectory

Revenue Trends

  • In 2022, Epiduo generated approximately $1.2 billion globally for Galderma.
  • The market for adapalene-benzoyl peroxide products is forecasted to sustain a CAGR of 4-6%, considering brand strength and pipeline developments.
  • Generics account for around 65% of the market share in mature regions, pressuring branded prices.

Pricing Dynamics

  • Average retail price per tube varies from $60 to $100, depending on formulation and region.
  • Generics reduce price points by ~50%, impacting revenue distribution for patent holders.

R&D Investment

  • Clinical development for new formulations or combination ratios costs approximately $20 million to $50 million per asset.
  • Additional expenses include regulatory submissions, post-market studies, and lifecycle management.

Future Revenue Streams

  • Biosimilar and OTC formulations could expand market access.
  • Novel formulations with improved acceptability may command premium pricing.

Market Risks and Opportunities

Risks

  • Patent expirations threaten revenue streams.
  • Increasing OTC availability could erode prescription-based revenues.
  • Competition from alternative therapies (topical antibiotics, oral therapies).

Opportunities

  • Development of once-daily or sustained-release formulations.
  • Personalization through targeted delivery systems.
  • Expansion into emerging markets with rising acne prevalence.

Conclusion

The adapalene and benzoyl peroxide combination segment remains a profitable sphere within acne treatment markets. While patent expirations and generic competition introduce revenue pressure, ongoing innovation and market expansion counterbalance these challenges. Investment in pipeline development and geographic expansion can support continued growth.

Key Takeaways

  • The global acne medication market is growing at 5.5% annually and valued at $4.8 billion (2022).
  • Epiduo is the market leader, with revenues around $1.2 billion in 2022.
  • Patent cliffs and OTC availability are key factors influencing future revenues.
  • Emerging formulations and markets present growth opportunities.
  • R&D investments continue to be essential for competitive positioning.

FAQs

Q1: When will the patent for Epiduo expire?
A1: The original patent expired in the United States in 2018; regional exclusivity varies globally, with some extending until 2025–2030.

Q2: What is the main driver behind the growth of adapalene-benzoyl peroxide products?
A2: Increasing prevalence of acne and clinical preference for combination therapies.

Q3: How does generics impact the market?
A3: Generics hold about 65% of market share in mature regions, leading to price reductions and volume-driven revenues for patent holders.

Q4: Which regions are expanding fastest?
A4: Asia-Pacific exhibits the fastest growth due to urbanization, income increases, and greater skincare awareness.

Q5: What are the main R&D considerations?
A5: Development costs range from $20 million to $50 million per product, focusing on safety, efficacy, and formulation innovation.


References

[1] MarketsandMarkets, "Acne Market," 2022.
[2] GlobalData, "Top Pharma Companies Report," 2023.
[3] Galderma Annual Report, 2022.
[4] FDA Drug Approvals, 2022.

More… ↓

⤷  Start Trial

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.