ACZONE Drug Patent Profile

Which patents cover Aczone, and when can generic versions of Aczone launch?

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
Catawba Research	Phase 3
Torrent Pharmaceuticals Limited	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			Y

Expired US Patents for ACZONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005

International Patents for ACZONE

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

Country	Patent Number	Title	Estimated Expiration
Mexico	PA02006593	DAPSONA TOPICA PARA TRATAMIENTO DEL ACNE. (TOPICAL DAPSONE FOR THE TREATMENT OF ACNE.)
Japan	2005524651
Slovenia	1485059
Spain	2280629
Mexico	362520	COMPOSICIONES DE DAPSONA Y DAPSONA/ADAPALENO TOPICAS Y METODOS PARA SU USO. (TOPICAL DAPSONE AND DAPSONE/ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF.)
South Africa	200407439

Market Dynamics and Financial Trajectory for ACZONE (Dapsone Gel 7.5%)

Last updated: July 27, 2025

Introduction

ACZONE (dapsone gel 7.5%) has established itself as a prominent topical treatment primarily indicated for acne vulgaris, especially inflammatory and severe forms. Approved by the U.S. Food and Drug Administration (FDA) in 2018, it offers a targeted therapeutic option for dermatologists and patients seeking alternatives to systemic antibiotics and other traditional therapies. This analysis explores the current market landscape, mechanisms shaping its financial trajectory, competitive positioning, regulatory considerations, and future growth prospects.

Market Overview

Product Profile and Therapeutic Position

ACZONE's active ingredient, dapsone, is a sulfone antibiotic with established anti-inflammatory properties. Approved explicitly for acne, it addresses unmet needs in topical therapy, particularly for patients intolerant or resistant to other treatments. Its mechanism involves the suppression of leukocyte activity and inflammatory mediators within sebaceous follicles, making it efficacious in inflammatory lesions.

Market Size and Penetration

The global acne treatment market, valued at approximately USD 4.8 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 6.2% through 2030 [1]. Within this sphere, topical agents comprise roughly 55%, representing a lucrative segment where ACZONE resides. As a niche but expanding product, ACZONE's market share remains modest but strategic, driven by the rising prevalence of acne across age groups and increasing demand for targeted dermatological therapies.

Market Dynamics Influencing ACZONE

1. Competitive Landscape

ACZONE faces competition from both topical and systemic agents. Key competitors include:

• Topical retinoids such as tretinoin and adapalene
• Topical antibiotics like clindamycin and erythromycin
• Combination therapies (e.g., benzoyl peroxide with antibiotics)
• Oral therapies including doxycycline, minocycline, and isotretinoin

Despite broad competition, ACZONE’s unique profile as a non-antibiotic, anti-inflammatory topical provides a differentiating factor, particularly amid the rising concern over antibiotic resistance [2]. This positions ACZONE favorably in positioning itself as an antibiotic-sparing option.

2. Regulatory Evolution & Labeling

While FDA approval in 2018 marked a pivotal milestone, ongoing regulatory conversations focus on expanding indications and aligning safety profiles. Notably, post-approval surveillance continues to shape its market viability. Additionally, health authorities’ emphasis on antimicrobial stewardship enhances the appeal of non-antibiotic treatments like ACZONE [3].

3. Prescribing Trends and Physician Acceptance

Physician acceptance hinges on clinical efficacy, safety, and ease of use. Data from recent dermatology surveys reflect increasing comfort among dermatologists to prescribe dapsone gel, especially for adolescent patients and those with inflammatory acne unresponsive to other topicals [4].

4. Pricing and Reimbursement Dynamics

Pricing strategies critically impact market penetration. ACZONE’s cost structure, with an average wholesale price (AWP) around USD 100 per 30g tube, influences patient access and insurance reimbursement. Reimbursement policies and formulary placements are evolving, with payers increasingly favoring non-antibiotic options to curb resistance and reduce costs associated with systemic therapies.

5. Patient Adoption and Compliance

Topical application fosters better compliance compared to systemic treatments. However, concerns about application frequency, potential skin irritation, and drug persistence can influence adherence. Educational initiatives promoting proper use bolster market growth [5].

Financial Trajectory and Revenue Projections

Current Revenue and Growth Factors

Since its market entry, ACZONE’s revenue has grown steadily, driven by expanding dermatology practices and increasing awareness. In 2022, sales worldwide approached USD 150 million, with North America accounting for over 70% of revenues. The growth trajectory is influenced by several factors:

• Market penetration in North America and Europe
• Expanding indications for inflammatory acne
• Strategic partnerships with healthcare providers and payers

Forecasting Future Revenue Streams

Analyst estimates project that ACZONE’s revenue will reach USD 300–400 million globally by 2027, contingent upon:

• Expansion into new markets, notably Asia-Pacific, where acne prevalence is high
• Indication expansion for other dermal inflammatory conditions
• Increase in prescribed formulations driven by changing prescribing habits

Challenges to Revenue Growth

Factors tempering growth include:

• Intense competition from other topicals and combination regimens
• Patent expirations and biosimilar entries, risking price erosion
• Market saturation in core regions

Regulatory and Patent Landscape

Although ACZONE’s patent protection extends into the mid-2020s, generic formulations threaten pricing stability. Strategic patent extensions and formulation innovations are crucial to maintaining competitive advantages.

Moreover, regulatory agencies’ focus on antimicrobial resistance underscores the strategic positioning of ACZONE as a non-antibiotic alternative. Future approvals for broader indications or combination products could further bolster its market presence [6].

Emerging Trends and Strategic Opportunities

1. Combination Therapies

Pairing ACZONE with other non-antibiotic agents (e.g., benzoyl peroxide or adapalene) offers synergistic benefits, improving efficacy and reducing resistance risks. Such combinations appeal to clinicians aiming for personalized, multi-mechanistic approaches.

2. Digital Dermatology and Telemedicine

Increasing adoption of teledermatology expands access to ACZONE prescriptions. Digital tools can also promote adherence and monitoring, enhancing treatment outcomes.

3. Rising Acne Incidence in Adults

Shifting demographic patterns, with a surge in adult-onset acne, create new demand streams. ACZONE’s efficacy in inflammatory lesions positions it as a preferred treatment option for this demographic.

4. Focus on Antibiotic Stewardship

Global health policies favor antibiotic-sparing strategies. ACZONE’s non-antibiotic profile aligns well with these initiatives, attracting the interest of prescribers committed to responsible prescribing.

Future Outlook

The market for ACZONE is poised for moderate but steady expansion. Its niche positioning amid increasing antibiotic resistance concerns, coupled with the expansion of acne indications and strategic partnerships, underpins its growth potential. However, competition and patent cliffs pose risks that require proactive product life cycle management.

Key Takeaways

• Growing Acne Market: The global acne treatment market's consistent growth predicates steady demand for novel topical therapies like ACZONE.
• Competitive Edge as a Non-Antibiotic: Its unique positioning aligns with global antimicrobial stewardship initiatives, favoring its adoption.
• Revenue Growth Potential: Projections indicate potential revenues of USD 300–400 million by 2027, driven by expansion into new markets and indications.
• Strategic Challenges: Patent expiration, biosimilar competition, and market saturation frame critical challenges.
• Opportunities for Expansion: Combining ACZONE with other agents, leveraging telemedicine, and targeting adult acne are promising avenues.

FAQs

1. What distinguishes ACZONE from other acne topical treatments?
ACZONE offers a non-antibiotic, anti-inflammatory mechanism of action, reducing concerns over antibiotic resistance and side effects associated with systemic antibiotics.

2. How does the market outlook for ACZONE compare to its competitors?
While competing with established agents like tretinoin and clindamycin, ACZONE’s non-antibiotic profile gives it a strategic edge, especially amidst increasing resistance concerns.

3. What are the main regulatory risks impacting ACZONE’s future?
Patent expirations, potential approval for additional indications, and evolving safety standards could influence its market exclusivity and reimbursement landscape.

4. How does payer policy influence ACZONE’s market growth?
Insurance coverage and formulary inclusion are pivotal. Favorable reimbursement terms bolster adoption, whereas high out-of-pocket costs may limit access.

5. What strategic moves can enhance ACZONE’s market penetration?
Formulation innovations, combination therapies, enhanced physician education, and expanded indications are key strategies to capture more market share.

---

References

[1] Grand View Research, "Acne Treatment Market Size & Trends By Product," 2022.
[2] World Health Organization, "Antimicrobial Resistance: Global Report," 2019.
[3] FDA, "Updating Drug Labels to Address Antibiotic Resistance," 2021.
[4] Dermatology Insights, "Physician Prescribing Trends for Acne," 2022.
[5] Journal of Cosmetic Dermatology, "Patient Adherence to Topical Acne Treatments," 2020.
[6] European Medicines Agency, "Regulatory Considerations for Acne Indications," 2021.