BENZOYL PEROXIDE; TRETINOIN - Generic Drug Details

What are the generic drug sources for benzoyl peroxide; tretinoin and what is the scope of freedom to operate?

Benzoyl peroxide; tretinoin is the generic ingredient in one branded drug marketed by Mayne Pharma and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Benzoyl peroxide; tretinoin has one hundred and three patent family members in fifteen countries.

Two suppliers are listed for this compound.

Summary for BENZOYL PEROXIDE; TRETINOIN

International Patents:	103
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	9
DailyMed Link:	BENZOYL PEROXIDE; TRETINOIN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BENZOYL PEROXIDE; TRETINOIN

Constraining patent/regulatory exclusivity:

11,071,878

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; TRETINOIN

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

Sponsor	Phase
GWT-TUD GmbH	Phase 4
Galderma Laboratories, L.P.	Phase 4
Zeichner, Joshua, M.D.	Phase 4

See all BENZOYL PEROXIDE; TRETINOIN clinical trials

Pharmacology for BENZOYL PEROXIDE; TRETINOIN

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for BENZOYL PEROXIDE; TRETINOIN

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

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

L01XF	Retinoids for cancer treatment
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for BENZOYL PEROXIDE; TRETINOIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	8,617,580		Y
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	12,257,348		Y
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	9,868,103		Y
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	11,071,878		Y
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	12,156,946		Y
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	12,053,546		Y

International Patents for BENZOYL PEROXIDE; TRETINOIN

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)
Japan	2013213063	COMPOSITION FOR TOPICAL APPLICATION COMPRISING PEROXIDE AND RETINOID
Spain	2611499
China	101754677	Method for preparing particles comprising metal oxide coating and particles with metal oxide coating
Japan	5934107
Spain	2902498

Supplementary Protection Certificates for BENZOYL PEROXIDE; TRETINOIN

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
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)

Market Dynamics and Financial Trajectory for Benzoyl Peroxide and Tretinoin in the Pharmaceutical Sector

Last updated: July 30, 2025

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Introduction

The pharmaceutical landscape for dermatological treatments has witnessed significant growth driven by the rising prevalence of acne vulgaris and various skin-related dermatological conditions. Two cornerstone agents—benzoyl peroxide and tretinoin—have sustained their market positions due to their proven efficacy and longstanding clinical use. This analysis explores the current market dynamics and forecasts the financial trajectory for these drugs, emphasizing their therapeutic significance, market drivers, competitive landscape, and future growth potential.

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Therapeutic Significance and Clinical Adoption

Benzoyl Peroxide has remained a first-line topical antimicrobial agent primarily combating acne vulgaris. Its bactericidal properties target Propionibacterium acnes, reducing inflammation and lesion formation. Its over-the-counter (OTC) availability enhances accessibility, fueling widespread adoption worldwide. In contrast, Tretinoin (all-trans-retinoic acid) plays a crucial role in treating acne, photoaging, and certain dermatological conditions such as keratosis pilaris and photo-damaged skin. It modulates cellular differentiation and proliferation, offering both therapeutic and cosmetic benefits.

The clinical acceptance of these agents remains robust, with multiple formulations—creams, gels, and unctions—catering to diverse patient needs. Their longstanding use and extensive safety profiles underpin their continuous prescription and OTC sales.

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Market Drivers

1. Rising Prevalence of Acne and Skin Conditions:
Globally, acne affects approximately 85% of adolescents and persists into adulthood for many, creating sustained demand for effective topical treatments like benzoyl peroxide and tretinoin [1]. An aging population also drives demand for tretinoin's antiaging benefits.

2. Increasing Awareness and Dermatological Consultations:
Awareness campaigns, coupled with easier access to dermatological care, have improved diagnosis rates and treatment adherence. The proliferation of OTC formulations particularly boosts benzoyl peroxide sales.

3. Product Innovation and Formulation Improvements:
Pharmaceutical companies are enhancing dermal delivery systems—microencapsulation, sustained-release formulations—to improve drug stability, reduce irritation, and increase patient compliance. Such innovations stimulate market growth.

4. Cosmetic and Antiaging Trends:
The rising consumer preference for skin rejuvenation treatments bolsters tretinoin sales, especially in mature markets. The antiaging segment is significantly expanding both within dermatology clinics and OTC channels.

5. Regulatory Environment:
Clear regulatory pathways, especially in emerging markets, facilitate product launches. However, some formulations (notably tretinoin) face regulatory scrutiny due to safety concerns, influencing market access.

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Competitive Landscape

The market for benzoyl peroxide is characterized by numerous generic producers, with brands like PanOxyl, Clean & Clear, and Oxy leading OTC sales globally. Patent expirations and generic proliferation have kept prices competitive, supporting broad dissemination.

Tretinoin’s market is more concentrated; it remains patented or under exclusive licensing agreements in several regions, although generics have eroded exclusive profitability. Top players include Johnson & Johnson, Ortho Dermatologics, and La Roche-Posay.

Innovator companies are actively investing in proprietary formulations—such as controlled-release tretinoin—to differentiate their products and extend market share [2].

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Market Size and Financial Trajectory

Historical Market Data

The global dermatology drug market, including benzoyl peroxide and tretinoin, was valued at approximately USD 5.7 billion in 2022, with acne medications accounting for a significant portion (>30%) of this figure [3].

Forecast and Growth Projections

The dermatology segment is projected to grow at a compounded annual growth rate (CAGR) of around 6% from 2023 to 2028, reaching an estimated USD 8.2 billion [4].

Specific forecasts indicate:

• Benzoyl Peroxide Market: Expected CAGR of nearly 5-6%, driven by OTC sales, product innovation, and expanding markets in Asia-Pacific and Latin America. Market size anticipated to approach USD 2.3 billion by 2028.

• Tretinoin Market: Projected CAGR of approximately 6-7%, supported by its dual role in cosmetic antiaging and acne therapy. Market value could reach USD 1.8 billion in five years, with a sustained shift towards combination therapies and dermatological plastic surgery adjuncts.

Key Growth Factors

• Digital health adoption enabling targeted advertising and tele-dermatology—facilitating faster prescription initiation and better adherence.
• Expansion into emerging markets bolstered by increasing urbanization, rising income levels, and evolving dermatological care infrastructure.
• Development of combination products—e.g., tretinoin coupled with other agents—improving efficacy and compliance.

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Market Challenges and Risks

Despite promising growth, several hurdles persist:

• Safety Concerns: Tretinoin’s irritant profile and teratogenic risks necessitate careful regulation, which may impede market expansion in certain regions.
• Resistance Development: Though limited, microbial resistance to benzoyl peroxide remains an area for ongoing monitoring.
• Regulatory Variability: Differing regional standards for OTC classifications and prescription status impact drug accessibility and profitability.
• Emerging Alternatives: Novel therapies such as laser treatments and oral medications (e.g., topical antibiotics, hormonal agents) could compete or substitute topical benzoyl peroxide and tretinoin.

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Strategic Opportunities

• Formulation Innovation: Developing less irritating, more tolerable formulations can expand usability across age groups and skin types.
• Combination Therapies: Fixed-dose combinations—e.g., benzoyl peroxide with clindamycin—have shown improved efficacy, offering higher value propositions.
• Market Expansion: Penetrating emerging markets through strategic alliances and affordable formulations unlocks substantial sales potential.
• Digital Platforms: Leveraging telemedicine and online sales channels increases reach, especially in underpenetrated geographies.

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Conclusion

The market for benzoyl peroxide and tretinoin is poised for steady growth driven by escalating demand for effective dermatological therapies, technological innovations, and expanding global markets. While challenges such as safety concerns and regulatory complexities persist, strategic formulation improvements, product diversification, and digitalization will underpin their strong financial trajectory over the coming years.

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Key Takeaways

• Market Resilience: Benzoyl peroxide and tretinoin, backed by decades of clinical data, remain foundational treatments, ensuring consistent demand.
• Growth Drivers: Rising acne prevalence, antiaging trends, and product innovations are primary growth engines.
• Opportunities in Emerging Markets: Rapid urbanization and increasing dermatology awareness unlock significant expansion prospects.
• Competition and Innovation: Patent expirations for tretinoin and market saturation for benzoyl peroxide necessitate innovation to sustain profitability.
• Regulatory Vigilance: Navigating safety standards and ruling discrepancies remains critical for global market access.

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FAQs

1. What are the primary drivers for benzoyl peroxide and tretinoin market growth?
   The main drivers include increasing prevalence of acne, rising antiaging cosmetic procedures, formulation innovations, and expanding dermatological awareness globally [1][2].

2. How do regulatory differences impact market prospects for these drugs?
   Variations in OTC and prescription classifications across regions influence accessibility, sales volume, and pricing strategies, affecting overall profitability.

3. What challenges might limit the future growth of these drugs?
   Safety concerns, emergence of new treatment modalities, resistance issues, and regulatory hurdles can temper growth prospects.

4. Are there emerging markets with significant potential for these drugs?
   Yes, Asia-Pacific and Latin America present high-growth opportunities due to demographic shifts, increasing disposable income, and expanding healthcare infrastructure.

5. How might digital health influence the market for benzoyl peroxide and tretinoin?
   Digital health tools facilitate teledermatology consultations, personalized treatment regimens, and online sales, broadening reach and improving adherence, thus enhancing market growth.

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References:

[1] World Health Organization, "Adolescent health and development," 2021.
[2] Johnson & Johnson, "Tretinoin formulations and clinical insights," 2022.
[3] Global Market Insights, "Dermatology drugs market size and trends," 2022.
[4] MarketsandMarkets, "Dermatology market forecasts," 2023.