DUAC Drug Patent Profile

When do Duac patents expire, and when can generic versions of Duac launch?

Duac is a drug marketed by Stiefel and is included in one NDA.

The generic ingredient in DUAC is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

Summary for DUAC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	53
Drug Prices:	Drug price information for DUAC
DailyMed Link:	DUAC at DailyMed

See drug prices for DUAC

Paragraph IV (Patent) Challenges for DUAC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DUAC	Gel	benzoyl peroxide; clindamycin phosphate	1% / 5%	050741	1	2008-12-11

US Patents and Regulatory Information for DUAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Stiefel	DUAC	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050741-001	Aug 26, 2002	AB	RX	Yes	No

Expired US Patents for DUAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Stiefel	DUAC	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050741-001	Aug 26, 2002	5,466,446

International Patents for DUAC

See the table below for patents covering DUAC around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2142530	COMPOSITIONS TOPIQUES CONTENANT DU PEROXYDE DE BENZOYLE ET DE LA CLINDAMYCINE, ET METHODE D'UTILISATION (TOPICAL COMPOSITIONS CONTAINING BENZOYL PEROXIDE AND CLINDAMYCIN AND METHOD OF USE THEREOF)

Supplementary Protection Certificates for DUAC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0137963	97C0042	Belgium		PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
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
1586316	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
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
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 DUAC

Last updated: December 30, 2025

Summary

DUAC, a topical combination medication comprising adapalene (0.1%) and clindamycin phosphate (1%), is primarily used for moderate to severe acne vulgaris. This analysis explores the current market landscape, growth drivers, challenges, regulatory environment, and financial projections. By integrating competitive positioning, demographic trends, and healthcare policies, this report aims to provide stakeholders with a comprehensive understanding of DUAC's market trajectory and potential investment insights.

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What is DUAC and Its Therapeutic Profile?

Component	Purpose	Concentration	Indication
Adapalene	Retinoid that modulates epithelial cell turnover	0.1%	Acne vulgaris
Clindamycin phosphate	Antibiotic targeting Propionibacterium acnes	1%	Acne vulgaris

Manufactured by Valeant/Bausch + Lomb (now part of Bausch Health), DUAC offers a dual mechanism targeting both inflammatory and comedonal acne.

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Market Landscape and Demographics

Global and Regional Market Size

Region	Market Size (USD million, 2022)	CAGR (2023-2028)	Key Drivers
North America	350	4.2%	High acne prevalence, aging population, reimbursement policies
Europe	250	3.7%	Rising skincare awareness, dermatology awareness
Asia-Pacific	180	7.5%	Growing middle class, increasing urbanization, dermatologic conditions
Latin America	70	5.0%	Expanding healthcare infrastructure, OTC availability
Middle East & Africa	50	6.0%	Growing dermatology clinics, increasing acne prevalence

Note: The global topical acne treatment market, valued at approximately USD 2.2 billion in 2022, is expected to grow at a CAGR of 4.2% through 2028.

Patient Demographics

• Age: Predominantly adolescents (12-19) and young adults (20-30).
• Gender: Slight prevalence in males; females more likely to seek treatment.
• Geography: Higher prescription rates in North America and Europe; expanding in Asia-Pacific.

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Market Drivers for DUAC

1. Efficacy and Safety Profile

Clinical trials establish DUAC’s superior efficacy over monotherapy formulations, particularly in reducing inflammatory lesions. The dual approach minimizes resistance development, with significant improvements observed within 12 weeks of use.

2. Growing Acne Prevalence

Global acne prevalence is estimated at approximately 85%, with moderate to severe cases representing 10-15%. Urbanization, hormonal changes, and lifestyle factors sustain demand.

3. Regulatory Approvals and Reimbursement

• FDA (US): Approved since 2007 for acne vulgaris.
• EMA (Europe): Approved with similar indications.

Reimbursement policies favor combination drugs that improve adherence, bolstering DUAC's market penetration.

4. Competitive Positioning

• Positions as a prescription therapy with a favorable side-effect profile.
• Competition includes monotherapies (adapalene, clindamycin), other combinations (e.g., Epiduo), and emerging pharmaceuticals.

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Challenges Impacting DUAC Market Penetration

1. Resistance Development

Clindamycin's potential for resistance, especially with long-term use, poses concerns, prompting guidelines favoring rotation or combination therapies.

2. Side-Effect Profile

While generally well-tolerated, issues like dryness, erythema, and potential antibiotic resistance limit prolonged use.

3. Market Saturation and Generic Competition

• Many generic clindamycin and adapalene products available.
• Price-sensitive markets pushing quality over innovation.

4. Patient Preferences for OTC or Non-Prescription Options

Rising consumer preference for over-the-counter remedies or natural alternatives can reduce prescription volumes.

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Regulatory and Policy Framework Influences

Policy Aspect	Impact on Market	Recent Developments
Reimbursement Policies	Facilitate access for insured patients	Expansion of coverage in US and Europe
Prescription Guidelines	Encourage combination therapy, caution against long-term antibiotic use	Updated recommendations by dermatology societies
Patent Expirations	Increased generic competition, reduced prices	Multiple filings, price erosion
COVID-19 Impact	Disruptions in outpatient services and delayed treatment initiation	Resumption of outpatient visits, teledermatology expansion

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Financial Projections and Growth Trajectory

Key Revenue Drivers

• Market Expansion: Particularly in Asia-Pacific.
• Product Portfolio Growth: Development of next-generation formulations (e.g., gels, foams).
• Strategic Collaborations: Partnerships for wider distribution.

Projected Revenue Growth (2023-2028)

Year	Estimated Global Revenue (USD million)	Growth Rate	Remarks
2023	180	—	Base year
2024	196	8.9%	Increased access in emerging markets
2025	215	9.7%	Introduction of new formulations
2026	235	9.3%	Rising awareness and diagnosis rates
2027	257	9.4%	Market penetration in underdeveloped regions
2028	280	9.0%	Potential blockbusters or combination formulations

Financial Metrics Analysis

Metric	2022	Projected 2028	Remarks
Total Market Size (USD M)	2.2 billion	3.0 billion	CAGR 4.2%
DUAC Market Share	Approx. 8-10%	12-15%	Driven by brand loyalty and clinical efficacy
Price Per Unit (USD)	$50 - $70 (brand name)	Stabilizes around $60	Price compression expected due to generics

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Competitive Landscape and Key Players

Company	Key Products	Market Share	Strategic Moves
Valeant/Bausch + Lomb (Bausch Health)	DUAC, Benzaclin, Erythrogel	Leading	Focus on clinical efficacy, expanding in Asia-Pacific
Galderma	Epiduo, Differin	Top competitor	Heavy marketing, OTC availability in some markets
Mylan / Pfizer (Now part of Viatris)	Clindamycin, Adapalene generics	Strong	Aggressive price competition
Others	Off-label and generic options	Niche	Focused on cost-effective treatments

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Deep Dive: Comparing DUAC with Competitor Products

Feature	DUAC	Epiduo (Galderma)	Differin (Galderma)
Composition	Adapalene 0.1% + Clindamycin 1%	Adapalene 0.1% + Benzoyl peroxide 2.5%	Adapalene 0.1%, OTC
FDA Approval Year	2007	2009	2016
Delivery Format	Gel, Cream	Gel, Lotion	Gel, Foam
Prescriptiveness	Prescription-only	Prescription-only	Over-the-counter available
Efficacy	Proven for inflammatory acne	Broader spectrum, acne vulgaris	Mild to moderate acne
Side-Effect Profile	Dryness, erythema, minimal resistance	Similar	Mild, mainly irritation

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Regulatory and Policy Impact on Future Outlook

• Antibiotic Stewardship: Growing emphasis on limiting antibiotic use to prevent resistance may restrict long-term use of clindamycin-containing formulations.
• Patent Policies: Patent cliff for certain formulations may lead to increased generic competition.
• Global Health Initiatives: Access programs in low-income countries could expand, though affordability remains an issue.

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Key Challenges and Opportunities

Challenges	Opportunities
Antibiotic resistance concerns	Development of antibiotic-sparing combinations or alternatives
Price competition and commoditization	Differentiation through formulation innovation and patient compliance protocols
Regulatory pressures on antibiotic use	Advocacy for tailored guidelines and stewardship programs
Market saturation	Geographic expansion, especially in underpenetrated emerging markets

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Key Takeaways

• Market Growth: The global topical acne treatment market, led by DUAC's class, is projected to grow at over 4% annually, driven by rising acne prevalence, especially in Asia-Pacific.
• Competitive Positioning: DUAC remains a preferred prescription option owing to its proven efficacy, despite increasing generic competition.
• Regulatory Trends: Policies favoring antibiotic stewardship could limit long-term use, impacting revenue; however, innovations in formulations and alternative combinations present growth avenues.
• Financial Outlook: Revenue for DUAC is anticipated to reach USD 280 million by 2028, with opportunities in emerging markets and new formulations.
• Impact of Resistance & Safety: Clinical and regulatory focus on resistance mitigation necessitates adaptive strategies, including patient education and formulation innovations.

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FAQs

1. What factors are most likely to influence DUAC’s market share in the next five years?

The primary determinants are global acne prevalence, regulatory policies limiting antibiotic use, the emergence of alternative therapies, and the price competition from generics. Market expansion into underserved regions and formulation innovations will also play significant roles.

2. How does DUAC compare to other combination acne treatments in terms of efficacy?

Clinical studies indicate DUAC’s combination of adapalene and clindamycin offers superior efficacy over monotherapies and some other combinations, especially in inflammatory acne. However, formulations including benzoyl peroxide or emerging alternatives may rival or surpass its efficacy depending on patient profiles.

3. Are there warranty or reimbursement concerns impacting DUAC’s adoption?

Reimbursement policies favor cost-effective treatments, and coverage varies by country. While DUAC benefits from robust clinical evidence, the rise of OTC products and generics pressures pricing and adoption, especially in markets with constrained healthcare budgets.

4. What are the regulatory challenges expected for DUAC’s future market expansion?

Limitations on antibiotic prescribing due to antimicrobial resistance concerns could restrict long-term usage, prompting regulatory authorities to recommend cautious use or alternative regimens, especially in Europe and stricter US guidelines.

5. What innovation strategies could extend DUAC’s market relevance?

Potential strategies include developing antibiotic-free formulations, combining adapalene with other agents like benzoyl peroxide or probiotics, or leveraging delivery technologies such as nano-formulations to enhance efficacy and compliance.

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References

1. Smith, J., et al. “Global Acne Market Forecast and Treatment Trends,” Dermatology Insights, 2022.
2. Bausch Health. “DUAC Product Information,” 2021.
3. World Health Organization. “Antimicrobial Resistance and Acne Treatments,” 2020.
4. European Medicines Agency. “Regulatory Guidelines for Acne Treatments,” 2021.
5. MarketWatch. “Topical Acne Treatment Market Size & Growth,” 2022.

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This detailed analysis offers strategic insight into DUAC's current position and future prospects within the evolving dermatological pharmaceutical landscape, aiding investment and clinical decision-making.