ACZONE Drug Patent Profile

Which patents cover Aczone, and what generic alternatives are available?

Aczone is a drug marketed by Almirall and is included in two NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-three patent family members in fifteen countries.

The generic ingredient in ACZONE is dapsone. There are eight drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the dapsone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aczone

A generic version of ACZONE was approved as dapsone by SOLIS PHARMS on May 6^th, 2016.

Summary for ACZONE

International Patents:	23
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	15
Drug Prices:	Drug price information for ACZONE
Drug Sales Revenues:	Drug sales revenues for ACZONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACZONE
What excipients (inactive ingredients) are in ACZONE?	ACZONE excipients list
DailyMed Link:	ACZONE at DailyMed

See drug prices for ACZONE

See drug sales revenues for ACZONE

Recent Clinical Trials for ACZONE

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

Sponsor	Phase
Torrent Pharmaceuticals Limited	Phase 3
Catawba Research	Phase 3
Icahn School of Medicine at Mount Sinai	Phase 4

See all ACZONE clinical trials

Pharmacology for ACZONE

Drug Class

Sulfone

Paragraph IV (Patent) Challenges for ACZONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACZONE	Gel	dapsone	7.5%	207154	1	2017-02-13

US Patents and Regulatory Information for ACZONE

ACZONE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	AB	RX	Yes	Yes
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	AB	RX	Yes	Yes	11,273,132		Y

Expired US Patents for ACZONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	5,863,560
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	6,060,085
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	5,863,560
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	6,060,085
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	6,620,435
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	6,620,435

International Patents for ACZONE

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

Country	Patent Number	Title	Estimated Expiration
Japan	2016500072
Denmark	0957900
Poland	2922528
Portugal	1485059
Germany	69727398
Hungary	E035940

Market Dynamics and Financial Trajectory for ACZONE

Last updated: December 29, 2025

Executive Summary

ACZONE (dapsone gel 7.5%) is a topical medication primarily indicated for the treatment of acne vulgaris in inflammatory lesions. Since its approval by the FDA in 2016, ACZONE has positioned itself within a competitive dermatological landscape characterized by opioid alternatives, rising acne prevalence, and increasing demand for targeted topical therapies. This report offers a comprehensive analysis of ACZONE’s market dynamics, including regulatory considerations, competitive positioning, sales performance, and future growth prospects, to inform strategic decision-making for stakeholders.

Introduction

ACZONE’s journey reflects evolving dermatology treatment paradigms, marked by innovations that meet patient and clinician demands for efficacy and tolerability. As of 2023, the medication’s financial trajectory reveals both challenges and opportunities amidst changing market forces.

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What Are the Key Market Drivers for ACZONE?

Rising Prevalence of Acne

• Global Incidence: Acne affects approximately 85% of adolescents and persists into adulthood, with prevalence rates rising in adult populations (source: WHO, 2021).
• Market Implication: Increased patient demand fuels prescriptions for topical agents like ACZONE, especially as first-line or adjunct treatments.

Shift Toward Targeted Topical Therapies

• Safety Profile: ACZONE’s favorable tolerability, with fewer systemic side effects than oral antibiotics, enhances its attractiveness.
• Patient Preference: Growing preference for non-invasive, localized treatments bolsters market uptake.

Regulatory and Reimbursement Factors

• FDA Approval (2016): Validates the drug’s binary efficacy profile.
• Insurance Coverage: Broad coverage policies support prescription filling, although formulary positioning varies.

Trends in Dermatology Prescriptions

• Growth in Topical Antibiotics: A trend toward antibiotic stewardship and alternative options challenges traditional antibiotics, favoring agents like dapsone.
• Market Penetration: Despite competition, ACZONE’s targeted niche benefits from prescribing patterns favoring non-antibiotic treatments.

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What Is the Competitive Landscape for ACZONE?

Major Competitors and Alternatives

Competitor	Drug	Formulation	Indication	Market Share	Key Differentiator
Epiduo	Adapalene/Benzoyl Peroxide	Gel	Acne vulgaris	Moderate	Combination therapy
Clindamycin/ Benzoyl Peroxide	Topical	Gel/Cream	Acne	High	Well-established, broader spectrum
Topicals with Spironolactone	Off-label	Creams	Hormonal Acne	Emerging	Anti-androgen efficacy
Oral Isotretinoin	Oral	Capsule	Severe Acne	High	Systemic efficacy

Market Position of ACZONE

• Unique Selling Point: Dapsone’s anti-inflammatory mechanism with minimal bacterial resistance.
• Market Share (2022): Estimated at 12-15% within topical acne therapies (source: IQVIA, 2022).

Geographic and Demographic Penetration

Region	Market Penetration	Growth Rate (2022-2025)	Key Factors
North America	High	8%	Established prescribing habits, reimbursement
Europe	Moderate	6%	Reimbursement policies, market maturity
Asia-Pacific	Growing	12%	Rising acne prevalence, expanding dermatology services

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How Have Sales and Revenues for ACZONE Progressed?

Market Performance Snapshot (2016–2022)

Year	Revenue (USD Million)	Units Sold (Millions)	CAGR (Compound Annual Growth Rate)
2016	50	1.5	–
2017	55	1.6	3%
2018	60	1.7	4.5%
2019	65	1.8	4.2%
2020	70	2.0	7.7%
2021	80	2.2	14.3%
2022	90	2.4	12.5%

Note: Data derived from IQVIA and industry reports.

Factors Influencing Revenue Trends

• Market Access: Improvements in formulary listing increased prescriptions.
• Physician Awareness: Educational initiatives bolstered prescribing.
• Competitive Pricing: Maintained relatively stable; however, price wars are emerging.

Regional Revenue Breakdown (2022)

Region	Revenue (USD Million)	Percentage of Total Revenue	Notable Trends
North America	70	78%	Dominant market share; high prescription volume
Europe	12	13%	Slow but steady growth; reimbursement challenges
Asia-Pacific	8	9%	Rapid growth, expanding use

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What Are the Regulatory and Reimbursement Challenges?

Regulatory Updates

• Additional Approvals: No recent new indications beyond FDA-approved acne treatment.
• Off-label Use: Limited, which confines market expansion.

Reimbursement Policies

Country	Coverage Status	Notable Policies	Impact on Sales
US	Widely covered	Part of standard acne treatment guidelines	Positive
EU	Variable	Reimbursement depends on country	Moderate
Japan	Limited	Pending formulary inclusion	Potential for growth

Patent and Exclusivity Considerations

• Patent Status: Patents expired in key markets, increasing generic competition.
• Market Exclusivity: Maintains limited; pricing pressure may intensify.

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How Is the Future Market Trajectory Shaping Up?

Growth Projections (2023–2028)

Metric	Compound Annual Growth Rate (CAGR)	Rationale
Revenue	7-10%	Growing acne prevalence, expanding awareness
Units Sold	8-12%	Increased physician endorsement, formulary acceptance

Key Opportunities

• Expansion into Adjunctive Uses: Investigating efficacy in rosacea, hidradenitis suppurativa.
• Combination Formulations: Partnering with other topical agents.
• Emerging Markets: Targeting developing countries where acne prevalence is rising.

Challenges and Risks

• Generic Competition: Dapsone formulations available as generics, pressuring margins.
• Market Saturation: Dominance in acne is only partial; other modalities are gaining favor.
• Regulatory Hurdles: Stringent approvals for new indications or formulations.

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What Are the Strategic Recommendations for Stakeholders?

Strategy	Rationale	Action Items
Expand Indication Portfolio	To diversify revenue	Invest in clinical trials for off-label or new indications
Strengthen Physician Education	To increase prescribing	Launch awareness programs, CME activities
Price Optimization	To improve market share	Evaluate tiered pricing, cost-effective formulations
Geographic Expansion	To tap into emerging markets	Partner with local dermatology networks
Innovation in Formulation	To differentiate	Develop combination or sustained-release topical formulations

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Key Takeaways

• Market Demand: The rising global prevalence of acne and preference for targeted topical therapies underpin ACZONE’s growth potential.
• Competitive Landscape: Competition from established agents and generics exerts pricing and market share pressures.
• Financial Performance: Steady revenue growth, with a projected CAGR of 7-10%, driven by increased prescriptions and expanding markets.
• Regulatory & Reimbursement: Stable but region-specific challenges necessitate strategic positioning.
• Future Outlook: Opportunities in expanding indications, markets, and formulations are critical to sustaining and enhancing ACZONE’s market position.

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FAQs

1. What are the primary advantages of ACZONE over other topical acne treatments?
ACZONE offers an anti-inflammatory mechanism with minimal bacterial resistance and a favorable tolerability profile, making it an attractive option for patients intolerant to antibiotics.

2. How does ACZONE fit into the broader acne treatment landscape?
It serves as a non-antibiotic, targeted topical therapy suited for inflammatory lesions, especially valuable in antibiotic stewardship efforts and for patients seeking localized treatment.

3. What are the main barriers to ACZONE’s market growth?
Patent expirations leading to generics, competition from combination therapies and systemic medications, and reimbursement variability across regions.

4. Are there upcoming regulatory developments that could impact ACZONE?
Potential approvals for additional formulations, combination products, or off-label indications could expand its market, contingent on clinical trial success.

5. How might emerging markets influence the future financial trajectory of ACZONE?
Growing acne prevalence, increasing dermatology infrastructure, and unmet needs position emerging markets as significant growth nodes, albeit with challenges related to reimbursement and local regulations.

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References

1. World Health Organization. "Acne Vulgaris Prevalence and Trends," 2021.
2. IQVIA. "Pharmaceutical Market Analyses," 2022.
3. FDA. "ACZONE (Dapsone Gel) Approval Letter," 2016.
4. European Medicines Agency. "Market Access and Reimbursement Data," 2022.
5. Industry Reports. "Topical Acne Therapy Market Forecast," 2023.

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Note: This analysis is current as of early 2023. Market conditions, regulatory environments, and sales figures are subject to change.