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-two 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:	32
Tradenames:	10
Applicants:	14
NDAs:	25
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	117
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

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
Ghurki Trust and Teaching Hospital	PHASE4
Aswan University	NA

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
Bausch	BENZACLIN	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050756-001	Dec 21, 2000		DISCN	Yes	No
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
Israel	189159	חיפוי של מתכת אוקסיד למרכיבים בלתי מסיסים במים (Metal oxide coating of water insoluble ingredients)
World Intellectual Property Organization (WIPO)	2020170035
Canada	2677185	METHODE DE PREPARATION DE PARTICULES COMPRENANT UN ENROBAGE D'OXYDE METALLIQUE, ET PARTICULES ENROBEES D'OXYDE METALLIQUE (METHOD FOR PREPARING PARTICLES COMPRISING METAL OXIDE COATING AND PARTICLES WITH METAL OXIDE COATING)

Supplementary Protection Certificates for benzoyl peroxide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0186118	SPC/GB05/029	United Kingdom		PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
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

Benzoyl peroxide Market Analysis and Financial Projection

Last updated: February 16, 2026

What Are the Market Dynamics for Benzoyl Peroxide?

Benzoyl peroxide (BP) remains a leading active ingredient in topical acne treatments. Its widespread familiarity, over-the-counter (OTC) availability, and established efficacy contribute to a steady market presence.

Market Size and Growth

The global acne treatment market was valued at approximately $4.2 billion in 2021, with benzoyl peroxide devices accounting for a significant share. The segment is projected to grow at a compound annual growth rate (CAGR) of 3-5% through 2028, driven by increasing consumer demand for OTC solutions and expanding dermatological awareness.

Key Market Drivers

• Consumer Preference for OTC medications: BP's OTC status makes it accessible, pushing consistent demand.
• Rising prevalence of acne: Especially among adolescents and young adults, increases the need for topical therapies.
• Product innovation: Enhanced formulations, including gels, creams, and cleansers, contribute to sustained consumer interest.
• Brand proliferation: Major pharmaceutical and cosmetic companies export BP-based products globally, expanding reach.

Market Challenges

• Adverse effects: Skin irritation and bleaching limit some users, prompting demand for alternative formulations.
• Competition from new ingredients: Such as systemic antibiotics and emerging topical agents, exert pressure on BP's market share.
• Regulatory constraints: Variations in OTC approvals and labeling regulations impact market expansion possibilities.

Regional Insights

• North America: Largest market share due to high consumer awareness and OTC accessibility.
• Europe: Growing awareness, but regulatory differences influence product availability.
• Asia-Pacific: Fastest growth rate (>6% CAGR) attributed to rising urbanization and acne prevalence.

What Is the Financial Trajectory of Benzoyl Peroxide?

The financial outlook is grounded in revenue stability, high-margin OTC products, and potential for generic proliferation.

Revenue Analysis

• The global benzoyl peroxide market generates an estimated annual revenue of $500 million to $700 million.
• Major players: Johnson & Johnson, Galderma, and local generic manufacturers dominate.

Pricing Trends

• BP is generally priced between $5 and $20 per tube or bottle, depending on formulation and brand. Wholesale prices have remained stable over the past five years.
• OTC formulations maintain healthy margins, especially for own-brand products and generics.

R&D and Regulatory Costs

• As a well-established compound, BP has minimal R&D investment costs when reformulating or improving existing products.
• Regulatory expenses vary by country but are relatively low compared to novel drugs, which accelerates market penetration.

Patent and Market Exclusivity

• BP formulations often face patent expirations within 5–10 years after initial approval, permitting generic manufacturing.
• Few patents protect BP's active ingredient itself, but formulations and delivery systems may hold patent protection.

Future Revenue Potential

• Market expansion into emerging regions is expected to stimulate revenue growth.
• Development of combination products with other acne agents could introduce premium pricing and increased margins.
• Opportunities exist for branded products leveraging novel delivery systems, but such innovations face significant R&D investments and regulatory hurdles.

What Are the Implications for Stakeholders?

• Manufacturers: Focus on cost-effective production, expanding regional presence, and innovation in formulation.
• Investors: BP remains a stable segment within OTC dermaceuticals, with moderate growth prospects.
• Regulatory Bodies: Maintain oversight to ensure product safety, especially concerning irritation and allergic reactions.

Key Takeaways

• Benzoyl peroxide holds a solid position in OTC acne markets with moderate growth prospects.
• Revenue streams derive mainly from established formulations, with generic competition limiting pricing power.
• Regional disparities influence market size, with North America and Asia-Pacific leading growth.
• Minimal R&D expenses and patent expiration facilitate market stability; innovation is mainly product reformulation or combination therapies.

FAQs

Q1: What are the primary competitors to benzoyl peroxide in acne treatment?
Topical retinoids, salicylic acid, and systemic antibiotics serve as main alternatives, especially for moderate to severe cases.

Q2: How does formulation influence marketability?
Gels tend to reduce irritation, whereas creams or washes appeal to different consumer segments. Innovations like timed-release or combination therapies can command premium pricing.

Q3: Can BP be used with other acne medications?
Yes, but caution is necessary due to increased irritation risk. Combining BP with retinoids or antibiotics is common under medical supervision.

Q4: Are there any regulatory concerns impacting BP's market?
Most countries treat BP as OTC, but restrictions exist on higher-strength products or formulations in some markets, influencing sales channels.

Q5: What is the outlook for new BP-based formulations?
Limited R&D investments are typical for a mature compound, but reformulations and delivery innovations provide incremental growth opportunities.

References

1. MarketWatch, "Global Acne Treatment Market," 2022.
2. Grand View Research, "Benzoyl Peroxide Market Analysis," 2021.
3. U.S. Food and Drug Administration, OTC Skin Products Regulation, 2022.
4. Johnson & Johnson Annual Report, 2021.
5. Galderma Corporate Overview, 2022.