ACZONE Drug Patent Profile

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

Aczone is a drug marketed by Abbvie and 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. Twenty-seven 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 NOSTRUM LABS INC on May 6^th, 2016.

Summary for ACZONE

International Patents:	23
US Patents:	1
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	151
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
Abbvie	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	207154-001	Feb 24, 2016	6,060,085
Abbvie	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	5,863,560
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	6,620,435
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	5,863,560
Abbvie	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	6,620,435
Abbvie	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	6,060,085

International Patents for ACZONE

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

Country	Patent Number	Title	Estimated Expiration
Poland	2922528
Canada	2855045
Hong Kong	1214516	局部氨苯碸和氨苯碸/阿達帕林組合物及其使用方法 (TOPICAL DAPSONE AND DAPSONE ADAPALENE COMPOSITIONS AND METHODS FOR USE THEREOF)
Australia	2013348247	Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Denmark	0957900
Canada	2776702	APPLICATION TOPIQUE DE DAPSONE POUR TRAITER L'ACNE (TOPICAL DAPSONE FOR THE TREATMENT OF ACNE)
Norway	20043877

ACZONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ACZONE (Dapsone Gel)

Introduction

ACZONE (dapsone) Gel is a prescription topical treatment for acne, approved by the U.S. Food and Drug Administration (FDA) in 2016 for patients 12 years and older. This article delves into the market dynamics and financial trajectory of ACZONE, highlighting its efficacy, market reception, and financial performance.

FDA Approval and Clinical Efficacy

ACZONE Gel, 7.5%, was approved by the FDA based on two identically designed, randomized, multi-centered, double-blind, vehicle-controlled 12-week studies involving 4,340 acne patients. These studies demonstrated the efficacy and tolerability of the gel in treating both inflammatory and non-inflammatory acne with once-daily application[1].

Market Launch and Availability

Following FDA approval, ACZONE Gel, 7.5%, was made available nationwide in May 2016. The product was marketed by Allergan plc, a leading global pharmaceutical company, which emphasized the new formulation's once-daily dosing and pump delivery system as key advantages[1].

Market Reception and Patient Response

The launch of ACZONE Gel, 7.5%, was well-received by both physicians and patients. Dr. Linda Stein Gold, a lead investigator in the clinical trials, noted that the new formulation was well-tolerated and showed significant improvement in patients' acne after 12 weeks of use. This positive reception is crucial for market acceptance and patient compliance[1].

Competitive Landscape

The acne treatment market is highly competitive, with various topical and oral treatments available. However, ACZONE Gel, 7.5%, stands out due to its specific concentration of dapsone and its once-daily application. The market also saw the introduction of generic versions, such as Cosette Pharmaceuticals' Dapsone 5% Gel, which is AB-rated to ACZONE 5% Gel, further expanding patient access to similar treatments[4].

Financial Performance of Allergan

Allergan's financial performance provides insight into the commercial success of ACZONE. In 2018, Allergan reported full-year GAAP net revenues of $15.79 billion, with a significant portion attributed to its dermatology segment. While specific revenue figures for ACZONE are not detailed, the overall performance of Allergan's dermatology products indicates a strong market presence[5].

Revenue and Sales Data

Although specific annual sales data for ACZONE Gel, 7.5%, are not publicly disclosed, the launch and continued marketing efforts suggest a positive revenue stream. For context, the US annual sales for Dapsone 5% Gel USP, a related product, were approximately $20 million for the 12 months ended December 2022, indicating a viable market for dapsone-based acne treatments[4].

Impact on Allergan's Financials

Allergan's financial reports show fluctuations in operating income and net revenues, but the company's commitment to the medical dermatology space, including products like ACZONE, remains a significant factor in its overall financial health. The company's non-GAAP operating income and adjusted EBITDA have been key metrics to watch, reflecting the performance of its pharmaceutical portfolio[5].

Market Growth and Projections

The pharmaceutical market, particularly the dermatology segment, has seen significant growth. Companies like Aptar, which supply components for drug delivery systems, have reported substantial increases in revenue and adjusted EBITDA from pharma end markets over the past five years. This growth trajectory suggests a favorable market environment for products like ACZONE[3].

Safety and Tolerability

The safety and tolerability of ACZONE Gel, 7.5%, were assessed in clinical trials, with the majority of patients experiencing moderate acne showing significant improvement. The product's tolerability is a critical factor in its market success, as it enhances patient compliance and satisfaction[1].

Physician and Patient Needs

ACZONE Gel, 7.5%, was developed with a focus on addressing physician and patient needs for an effective, easy-to-use acne treatment. The once-daily application and new pump delivery system were designed to improve patient adherence and satisfaction, which are key drivers of market success[1].

Regulatory Environment

The FDA approval process for ACZONE Gel, 7.5%, involved rigorous clinical trials to ensure safety and efficacy. This regulatory oversight is crucial for maintaining public trust and ensuring that products meet high standards of quality and effectiveness[1].

Conclusion

ACZONE (dapsone) Gel has established itself as a significant player in the acne treatment market since its FDA approval in 2016. Here are the key takeaways:

• Clinical Efficacy: Proven efficacy in treating both inflammatory and non-inflammatory acne.
• Market Reception: Well-received by physicians and patients due to its once-daily application and tolerability.
• Financial Performance: Contributes to Allergan's overall financial health, though specific revenue figures are not disclosed.
• Competitive Landscape: Faces competition from generic versions but remains a strong option due to its unique formulation.
• Market Growth: Benefits from the growing pharmaceutical market, particularly in the dermatology segment.

Key Takeaways

• Efficacy and Tolerability: ACZONE Gel, 7.5%, has demonstrated significant improvement in acne patients with once-daily application.
• Market Acceptance: The product's ease of use and tolerability have contributed to its positive market reception.
• Financial Impact: While specific figures are not available, ACZONE contributes to Allergan's overall financial performance.
• Regulatory Compliance: The product has met rigorous FDA standards for safety and efficacy.
• Market Growth: The dermatology segment continues to grow, favoring products like ACZONE.

FAQs

Q: What is ACZONE Gel, 7.5%, used for? A: ACZONE Gel, 7.5%, is a prescription topical treatment used to treat acne in patients 12 years and older.

Q: How was ACZONE Gel, 7.5%, approved by the FDA? A: It was approved based on two identically designed, randomized, multi-centered, double-blind, vehicle-controlled 12-week studies involving 4,340 acne patients.

Q: What are the key benefits of ACZONE Gel, 7.5%? A: The key benefits include once-daily application, a new pump delivery system, and significant improvement in acne after 12 weeks of use.

Q: How does ACZONE Gel, 7.5%, compare to other acne treatments? A: It stands out due to its specific concentration of dapsone and once-daily application, although generic versions like Cosette Pharmaceuticals' Dapsone 5% Gel are also available.

Q: What is the financial impact of ACZONE Gel, 7.5%, on Allergan? A: While specific revenue figures are not disclosed, ACZONE contributes to Allergan's overall financial performance, particularly in the dermatology segment.

Sources

1. Allergan Announces FDA Approval of ACZONE® (dapsone) Gel, 7.5% - PR Newswire
2. Allergan Reports Second Quarter 2019 Financial Results - AbbVie News
3. Aptar Investor Day 2023 - Aptar
4. Cosette Pharmaceuticals Launches Dapsone 5% Gel, AB-Rated to ACZONE 5% Gel - BioSpace
5. Allergan Reports Fourth Quarter and Full-Year 2018 Financial Results - AbbVie News