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

Constraining patent/regulatory exclusivity:

12,350,382

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
Mayne Pharma	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	11,426,378
Sun Pharma Canada	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	206575-001	Aug 19, 2019	AB	RX	No	No
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	8,288,434		Y
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	11,071,878		Y
Encube	ERYTHROMYCIN AND BENZOYL PEROXIDE	benzoyl peroxide; erythromycin	GEL;TOPICAL	065112-001	Mar 29, 2004		DISCN	No	No
Chartwell Rx	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	203688-001	Aug 25, 2016		DISCN	No	No
Mayne Pharma	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	11,865,100

International Patents for benzoyl peroxide

Country	Patent Number	Title	Estimated Expiration
Canada	3130362	PROCEDE PERMETTANT DE FOURNIR UN DEBUT D'ACTION PRECOCE DANS LE TRAITEMENT DE LA ROSACEE (METHOD FOR PROVIDING EARLY ONSET OF ACTION IN THE TREATMENT OF ROSACEA)
Canada	3130437	METHODE DE TRAITEMENT DE LA ROSACEE (METHOD FOR TREATMENT OF ROSACEA)
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)
Canada	3130441	METHODE DE TRAITEMENT DE SYMPTOMES D'ERYTHEME MODERE A SEVERE CHEZ DES PATIENTS ATTEINTS DE ROSACEE (METHOD FOR TREATMENT OF MODERATE TO SEVERE ERYTHEMA SYMPTOMS IN ROSACEA PATIENTS)
World Intellectual Property Organization (WIPO)	2020170029
World Intellectual Property Organization (WIPO)	2020170030
World Intellectual Property Organization (WIPO)	2020170031

Supplementary Protection Certificates for benzoyl peroxide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	SPC/GB10/005	United Kingdom		PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
0591275	SPC/GB05/030	United Kingdom		PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
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
1586316	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
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
1667986	92172	Luxembourg		PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)

Benzoyl Peroxide: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is the benzoyl peroxide commercial base?

Benzoyl peroxide is a mature, off-patent dermatology active used primarily for acne and related inflammatory skin conditions. The market is characterized by:

• Generic and OTC saturation: high formulation competition (creams, gels, washes) and frequent price pressure.
• Low therapeutic differentiation: near-homogeneous active ingredient value proposition; competition shifts to tolerability, vehicle, and penetration of retail channels.
• Regulatory fragmentation by geography: product approvals are country-specific, which sustains local competition and keeps pricing elastic.

Commercial footprint by route/form factor

• OTC retail: acne wash and topical acne gels/creams are standard in major retail pharmacies and e-commerce.
• Rx dermatology: prescription strengths and combinations exist in some markets, but the active remains broadly available as generics and OTC.

How do market dynamics shape pricing and demand?

1) Supply structure: multi-manufacturer, low barrier

Benzoyl peroxide is widely manufactured and sold by multiple generic and consumer-health suppliers. That structure drives:

• Price compression: active ingredient commoditization pushes down net pricing.
• Marketing-led differentiation: formulation science (vehicle, stability, release) and branding matter more than “new-to-market” clinical innovation.

2) Competitive set: acne pipeline replacement risk is low but substitution is high

Because acne remains a chronic condition with high recurrence, category demand is sticky. Still, benzoyl peroxide competes against:

• Topical retinoids
• Topical antibiotics (where appropriate)
• Fixed-combination acne regimens (e.g., benzoyl peroxide plus antibiotics in some markets)

The practical implication for financial trajectory: growth is mostly volume- and channel-led, not driven by premium pricing.

3) Channel dynamics: OTC access reduces volatility

OTC distribution smooths revenue drawdowns versus pure Rx products. Product availability through retail pharmacy chains and online marketplaces supports:

• Stable base consumption
• Rapid promotional cycles and trade spend
• Faster price normalization after temporary shortages

4) Regulatory and safety considerations influence formulation upgrades, not the active

Benzoyl peroxide’s known irritation and bleaching effects (clothing/hair) influence formulation choices and labeling practices. This supports incremental upgrades (vehicle changes, tolerability adjustments) without changing the active’s market role.

What is the financial trajectory implied by the asset type?

Benzoyl peroxide behaves like a mature commodity dermatology active. The financial trajectory expected in the market typically shows:

• Gradual revenue plateau at the active level due to saturation.
• Margin pressure from generic competition and OTC price competition.
• Share gains by brand/formulation rather than by new clinical indications.

Revenue growth profile

Across mature dermatology actives, the common pattern is:

• Unit volume grows modestly with population base and acne prevalence.
• Average selling prices decline or stay flat due to competitive pricing.
• Profit pools concentrate in efficient manufacturing and distribution, and in formulation differentiation that sustains higher net prices.

Cost structure

Financial performance is driven by:

• Manufacturing scale and yield for peroxide handling and stability
• Packaging and distribution logistics (topical formats)
• Trade spend and retail promotions in OTC channels
• Regulatory maintenance for product registrations and labeling

Investment logic

For R&D investors, the “payoff” is usually:

• Better formulation economics and stability
• Combination products that increase adherence and reduce substitution
• Line extensions with improved tolerability to preserve pricing power

For brand holders, the “defense” is:

• Manufacturing cost control
• Continuous retail execution and shelf presence
• Brand equity that delays migration to the cheapest generics

Where does growth concentrate: indications, combinations, or geographies?

Indications

The core indication remains acne. The market’s long-run expansion is constrained because benzoyl peroxide is already entrenched in acne care pathways.

What does change over time:

• Treatment protocols and guideline emphasis in acne
• Shifts toward combination regimens and stepwise care

Combinations

Benzoyl peroxide is often paired with other actives in acne regimens in different geographies, influencing:

• Prescriber and patient preference
• Adherence and reduced regimen complexity

Combination products can support better monetization than stand-alone actives, but the active-level pricing still faces generic pressure.

Geographies

Benzoyl peroxide’s market is large in major dermatology-consuming regions. OTC penetration in each geography drives:

• Retail price levels and promotional intensity
• Market share movement between manufacturers

How does IP status constrain long-term revenue upside?

Benzoyl peroxide is an old active and is broadly available; this limits:

• New entrant pricing power
• Sustained premium pricing
• Long-duration exclusivity returns

The economic effect is a typical “race-to-commodity” dynamic at the active level, with any sustained value captured primarily through:

• Proprietary formulations and process improvements
• Trademarked brand positions
• Local regulatory or marketing advantages

What financial metrics should investors track for benzoyl peroxide businesses?

For operators with exposure, the core KPIs are operational rather than clinical:

1. Net sales per unit (track ASP erosion in OTC and Rx)
2. Gross margin by geography and format (gel vs wash vs cream often differ)
3. Share of shelf and trade spend efficiency (OTC retailers)
4. Inventory turns and peroxide supply costs (peroxide handling and procurement)
5. Brand/formulation mix (stability and tolerability upgrades that support pricing)

Market value chain: what determines profitability?

Upstream

• Commodity inputs and peroxide sourcing
• Stability and handling costs during manufacturing
• Scale efficiencies

Downstream

• Formulation costs (vehicle, excipients)
• Packaging costs (topical dispensing formats)
• Retail and pharmacy trade spend
• Returns and damage costs for peroxide products (shipping and packaging design)

The financial trajectory is therefore more sensitive to manufacturing and distribution execution than to clinical differentiation.

What does the competitive landscape imply for near-term trajectory?

Near-term expectations for benzoyl peroxide-focused businesses:

• Flat-to-low growth in revenue from the category’s maturity and saturation.
• Ongoing margin compression where competition is strongest and promotional intensity is high.
• Outperformance for scaled manufacturers and fast formulation iteration that reduce unit costs and maintain net pricing.

In short, the “financial upside” is mostly tied to operational execution and mix shift rather than breakthrough innovation.

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Key Takeaways

• Benzoyl peroxide is a mature, off-patent dermatology active with OTC and generic saturation, driving price pressure and margin constraints.
• Market demand is stable but not premium-priced; growth is volume and channel execution rather than clinical exclusivity.
• Financial trajectory for benzoyl peroxide businesses is typically revenue plateau with competitive ASP erosion, with profit determined by manufacturing scale, formulation mix, and trade effectiveness.

FAQs

1. Is benzoyl peroxide mostly OTC or Rx?
   It is widely available OTC as acne washes, gels, and creams, with Rx options varying by country and strength/formulation.

2. What drives benzoyl peroxide unit demand?
   Chronic acne prevalence and recurring treatment cycles, supported by strong retail access.

3. What is the main threat to revenue growth?
   Generic and OTC price competition and substitution to alternative acne actives.

4. Where can companies improve margins in benzoyl peroxide?
   Through manufacturing scale, improved formulation stability, and mix shift toward products that sustain better net pricing.

5. Does the asset have meaningful exclusivity upside?
   No; broad availability limits long-duration exclusivity. Economic value tends to come from formulation, brand, and distribution execution.

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References

[1] PubChem. Benzoyl Peroxide. https://pubchem.ncbi.nlm.nih.gov/compound/Benzoyl-peroxide
[2] FDA. Benzoyl peroxide products (OTC monograph information and regulatory references). https://www.fda.gov/
[3] National Health Service (NHS). Benzoyl peroxide topical information. https://www.nhs.uk/conditions/skin-conditions/benzoyl-peroxide/