Benzoyl peroxide - Generic Drug Details

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

Benzoyl peroxide is the generic ingredient in ten branded drugs marketed by Mayne Pharma, Bausch, Actavis Labs Ut Inc, Chartwell Rx, Encube, Glenmark Speclt, Mylan Pharms Inc, Padagis Israel, Sun Pharma Canada, Zydus Pharms, Stiefel, Biofrontera, Valeant Intl, and Rising, and is included in twenty-five NDAs. There are thirty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Benzoyl peroxide has fifty-one patent family members in fifteen countries.

There are seven drug master file entries for benzoyl peroxide. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for benzoyl peroxide

International Patents:	51
US Patents:	31
Tradenames:	10
Applicants:	14
NDAs:	25
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	116
Patent Applications:	5,460
Drug Prices:	Drug price trends for benzoyl peroxide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for benzoyl peroxide
What excipients (inactive ingredients) are in benzoyl peroxide?	benzoyl peroxide excipients list
DailyMed Link:	benzoyl peroxide at DailyMed

See drug prices for benzoyl peroxide

See drug sales revenues for benzoyl peroxide

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for benzoyl peroxide

Constraining patent/regulatory exclusivity:

9,868,103

Dosage:

CREAM;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 benzoyl peroxide

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

Sponsor	Phase
Greg Bew	PHASE2
Aswan University	NA
Hasanuddin University	PHASE2

See all benzoyl peroxide clinical trials

Generic filers with tentative approvals for BENZOYL PEROXIDE

Applicant	Application No.	Strength	Dosage Form
		3.75%; EQ 1.2% BASE	GEL;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for benzoyl peroxide

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

US Patents and Regulatory Information for benzoyl peroxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y
Sun Pharma Canada	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	208683-001	Jun 5, 2018	AB	RX	No	No
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes			Y
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes			Y

International Patents for benzoyl peroxide

Country	Patent Number	Title	Estimated Expiration
Canada	3130439	METHODE DE TRAITEMENT DE LA ROSACEE CHEZ DES PATIENTS AGES DE 65 ANS ET PLUS (METHOD FOR TREATMENT OF ROSACEA IN PATIENTS AGED 65 YEARS AND OLDER)
Australia	2008211554
Canada	3130362
European Patent Office	2545776	Procédé de préparation de particules comprenant un revêtement d'oxyde métallique et particules à revêtement d'oxyde métallique (Method for preparing particles comprising metal oxide coating and particles with metal oxide coating)
Israel	189159	חיפוי של מתכת אוקסיד למרכיבים בלתי מסיסים במים (Metal oxide coating of water insoluble ingredients)

Supplementary Protection Certificates for benzoyl peroxide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	122008000041	Germany		PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369	C01458369/01	Switzerland		PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1586316	SPC/GB11/054	United Kingdom		PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
1586316	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
0526708	C300097	Netherlands		PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228

Market Dynamics and Financial Trajectory for Benzoyl Peroxide

Last updated: July 30, 2025

Introduction

Benzoyl peroxide (BP), a topical antimicrobial and keratolytic agent primarily used for treating acne vulgaris, occupies a significant niche in dermatological pharmacotherapy. With a history dating back to the 1950s, BP remains one of the most prescribed over-the-counter (OTC) and prescription medications for acne management. Its well-established efficacy, safety profile, and affordability underpin its sustained market presence. Yet, evolving dermatological treatment paradigms, consumer preferences, regulatory landscapes, and competitive innovation continue to shape its market dynamics and financial outlook.

Market Overview

The global benzoyl peroxide market was valued at approximately USD 350 million in 2022 and is projected to register a compound annual growth rate (CAGR) of 4-6% through 2030 [1]. The steady growth reflects increasing global acne prevalence, rising awareness of over-the-counter skin health solutions, and ongoing pharmaceutical innovation. The market encompasses OTC formulations, prescription products, and a spectrum of combination therapies.

Drivers of Market Growth

Rising Acne Prevalence

Acne vulgaris affects an estimated 9.4% of the global population, making it a common dermatological concern across age groups, particularly adolescents and young adults [2]. Urbanization, hormonal fluctuations, and lifestyle factors sustain high demand for effective, affordable treatments like benzoyl peroxide.

Consumer Shift Towards OTC Products

The convenience and accessibility of OTC BP formulations foster their popularity among consumers. Healthcare systems increasingly favor OTC options that mitigate clinic visits, reducing healthcare costs and aligning with self-care trends. Regulatory agencies, including the FDA (U.S.), EMA (Europe), and others, have facilitated OTC availability for lower-strength BP products, broadening market access [3].

Efficacy and Tolerability

Benzoyl peroxide demonstrates rapid bacterial (Propionibacterium acnes) eradication, reduces inflammatory lesions, and exhibits low resistance development—a competitive edge over antibiotics. Its broad-spectrum antimicrobial activity with a favorable safety profile sustains its therapeutic relevance.

Market Challenges

Skin Irritation and Bleaching

Adverse effects, including skin dryness, peeling, erythema, and bleaching of fabrics or hair, impact patient compliance and market penetration, especially for first-time users. Innovations aiming to reduce irritation are a critical focus for manufacturers.

Emerging Alternatives and Combination Therapies

Prescription renewals increasingly favor combination products (e.g., BP with adapalene or clindamycin) that target multiple pathogenic mechanisms. While these may limit standalone BP volume, they open incremental growth pathways owing to additive sales.

Regulatory and Quality Control Variability

Global regulatory discrepancies influence formulation standards, labeling, and availability. Stringent regulations, such as restrictions on benzoyl peroxide concentrations in certain jurisdictions, can influence market maturity and growth.

Technological and Product Innovation

Formulation Improvements

Advancements include sensitive skin formulations, microencapsulation techniques, and gel or foam vehicles enhancing penetration and tolerability. These innovations expand user acceptability, particularly among sensitive skin populations.

Combination and Novel Delivery Systems

Combination therapies, integrating benzoyl peroxide with retinoids or antibiotics, have gained popularity due to superior efficacy, albeit impacting standalone BP market dynamics. Additionally, novel delivery systems (e.g., sustained-release formulations) aim to optimize therapeutic outcomes and compliance.

Regulatory Trends and Patent Landscape

Although benzoyl peroxide is largely off-patent, the development of proprietary formulations and delivery systems remains vital for manufacturers seeking competitive differentiation and premium pricing. Regulatory frameworks influence product launches, labeling, marketing, and patent strategies, shaping long-term financial trajectories.

Financial Outlook

Revenue Generation

The expansion of OTC sales channels and increasing demand in emerging markets such as Asia-Pacific propel revenue growth. In developed markets, the focus shifts toward value-added products with improved tolerability and efficacy.

Market Entry and Expansion

New entrants, including pharmaceutical and cosmetic companies, are exploring reformulated or combination products to capture niche segments, promising incremental revenue streams.

Impact of Market Saturation and Competitive Pricing

Price erosion due to generic competition moderates profit margins, especially in mature markets. Manufacturers invest in marketing, formulation differentiation, and educational campaigns to sustain market share.

Emerging Market Opportunities

Rapid urbanization, rising acne awareness, and increasing disposable incomes in regions like Asia-Pacific, Latin America, and Africa offer significant growth opportunities. Local regulatory adaptations and strategic distribution partnerships are instrumental to success in these territories.

Conclusion

The benzoyl peroxide market is characterized by steady growth driven by acne prevalence, consumer preferences, and ongoing innovation efforts. While challenges exist—such as skin irritation concerns and genetic competition—product enhancements and expansion into emerging markets underpin its resilient financial trajectory. Future success hinges on technological advancements, regulatory navigation, and strategic marketing emphasizing safety, efficacy, and convenience.

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Key Takeaways

• Market stability is underpinned by benzoyl peroxide’s proven efficacy, affordability, and established position in acne management.
• Innovation in formulations and delivery systems will be pivotal to address tolerability issues and extend user adherence.
• Emerging markets present lucrative opportunities due to rising skincare awareness and disposable incomes.
• Competition from combination therapies necessitates differentiation strategies, potentially through proprietary formulations.
• Regulatory variability influences product availability, with future trends favoring simplified approval pathways for novel delivery systems.

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FAQs

1. What are the primary factors driving the demand for benzoyl peroxide worldwide?
Rising acne prevalence, consumer preference for OTC solutions, and its proven antimicrobial efficacy primarily drive demand globally.

2. How do innovation and formulation improvements impact benzoyl peroxide’s market outlook?
Innovations that improve tolerability, reduce irritation, and enhance efficacy expand user acceptance, particularly among sensitive skin users, bolstering market growth.

3. What challenges threaten the market stability of benzoyl peroxide products?
Adverse skin reactions, competition from combination therapies, regulatory restrictions, and price competition from generics pose risks.

4. How significant are emerging markets for the future growth of benzoyl peroxide?
Highly significant. Rapid urbanization and increasing skincare awareness in Asia-Pacific, Latin America, and Africa are expected to substantially contribute to global growth.

5. Will patent expiration impact benzoyl peroxide’s profitability?
Most formulations are already generic, so patent expiry limits proprietary gains. Future profitability depends on formulation innovation and brand differentiation.

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Sources

[1] Market Research Future, "Global Benzoyl Peroxide Market Report," 2022.
[2] World Health Organization, "Global Acne Prevalence," 2018.
[3] U.S. Food and Drug Administration, "OTC Acne Products," 2020.