ACANYA Drug Patent Profile

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

Acanya is a drug marketed by Bausch and is included in one NDA. There are six patents protecting this drug.

This drug has twenty patent family members in fourteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Acanya

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ACANYA

International Patents:	20
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Drug Prices:	Drug price information for ACANYA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACANYA
What excipients (inactive ingredients) are in ACANYA?	ACANYA excipients list
DailyMed Link:	ACANYA at DailyMed

See drug prices for ACANYA

See drug sales revenues for ACANYA

Recent Clinical Trials for ACANYA

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

Sponsor	Phase
Taro Pharmaceuticals USA	Phase 1
Watson Laboratories, Inc.	Phase 3
Perrigo Company	Phase 3

See all ACANYA clinical trials

Pharmacology for ACANYA

Drug Class	Lincosamide Antibacterial
Physiological Effect	Decreased Sebaceous Gland Activity

US Patents and Regulatory Information for ACANYA

ACANYA is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes			Y
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes			Y
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes			Y
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes

Expired US Patents for ACANYA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008

International Patents for ACANYA

When does loss-of-exclusivity occur for ACANYA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

European Patent Office

Japan

Mexico

Portugal

Russian Federation

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ACANYA around the world.

Country	Patent Number	Title	Estimated Expiration
China	1077887
Croatia	P20200450
European Patent Office	2299810	FORMULATIONS PHARMACEUTIQUES TOPIQUES CONTENANT UNE FAIBLE CONCENTRATION DE PEROXYDE DE BENZOYLE EN SUSPENSION DANS DE L'EAU ET UN SOLVANT ORGANIQUE MISCIBLE AVEC L'EAU (TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT)
Mexico	2010013152	FORMULACIONES FARMACEUTICAS TOPICAS QUE CONTIENEN UNA BAJA CONCENTRACION DE PEROXIDO DE BENZOILO EN SUSPENSION EN AGUA Y UN SOLVENTE ORGANICO MISCIBE EN AGUA. (TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT.)
Spain	2773931
Spain	2153377

Supplementary Protection Certificates for ACANYA

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
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
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
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
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

Market Dynamics and Financial Trajectory for Acne Drugs: A Focus on ACANYA

Introduction to Acne Drugs Market

The global acne drugs market is experiencing significant growth, driven by several key factors. These include the increasing prevalence of acne, lifestyle changes, rising skin awareness, and growing cosmetic concerns[4].

Market Size and Growth

As of 2023, the global acne drugs market was valued at $9.22 billion and is projected to grow at a compound annual growth rate (CAGR) of 5.2% from 2024 to 2030. This growth is anticipated to reach $7.3 billion by 2028, with a CAGR of 4.5% in the forecast period[1][4].

Key Drivers of the Market

Increasing Prevalence of Acne

Acne is the most common skin condition, affecting 9.4% of the global population, making it the eighth most prevalent disease worldwide. This high prevalence is a significant driver of the acne drug market[4].

Lifestyle Changes and Skin Awareness

Changes in lifestyle, including sedentary lifestyles and unhealthy dietary habits, contribute to the increasing incidence of acne. Additionally, rising skin awareness and growing cosmetic concerns are driving the demand for acne treatments[4].

Economic Factors

An increase in disposable income and healthcare expenditure is also a major driver. Improved economic conditions lead to higher wages and salaries, boosting healthcare spending and the demand for acne treatments[1].

Market Trends

Narrow Spectrum Antibiotics and Combination Therapies

Investments in narrow spectrum antibiotics and the development of combination therapies for acne treatment are trending. These advancements aim to provide more effective and targeted treatments with fewer side effects[1].

Cannabis Products

There is a growing interest in cannabis products, including cannabis oil, for acne treatment. This trend reflects the broader acceptance and research into the therapeutic benefits of cannabis[1].

Partnerships and Collaborations

Companies are increasingly engaging in partnerships to develop new drugs and expand their market reach. For example, Hyphens Pharma International Limited entered into a license and supply agreement with Cassiopea S.p.A. to commercialize Winlevi, an acne drug, in several ASEAN countries[4].

Online Pharmacies

The rise of online pharmacies is another significant trend. Online pharmacies are expected to register the fastest CAGR of 6.6% during the forecast period, driven by increased internet connectivity, consumer awareness, and the telemedicine sector[4].

Financial Trajectory

Revenue Projections

The acne drugs market is expected to grow steadily, with revenues projected to reach $7.3 billion by 2028. This growth is supported by factors such as faster economic growth, rising healthcare expenditure, and the high potential of emerging economies[1].

Segment Growth

The Asia Pacific region is estimated to register the fastest CAGR over the forecast period, driven by high acne prevalence among adolescents and increasing R&D activities by companies in the region[4].

Specifics on ACANYA

What is ACANYA?

ACANYA is a topical gel formulation containing clindamycin phosphate and benzoyl peroxide, commonly used for the treatment of acne.

Market Size and Growth

The clindamycin phosphate and benzoyl peroxide market, which includes products like ACANYA, is projected to reach USD 0.39 billion by 2032, growing at a CAGR of 6.2% from its current value. By 2029, this market is expected to reach USD 322.8 million[3].

Driving Factors

The growth of ACANYA and similar products is driven by increasing consumer demand for personalized skincare solutions and advancements in drug delivery technologies. These factors enhance the efficacy and user experience of acne treatments[3].

Key Players and Market Strategies

R&D and Collaborations

Companies involved in the acne drugs market, including those producing ACANYA, are focusing on R&D activities and collaborations. These efforts aim to develop new and more effective treatments, as well as expand market reach through licensing agreements and partnerships[4].

Marketing Strategies

The use of social media to market acne treatment products is becoming more prevalent. This strategy helps in reaching a wider audience, especially the younger demographic that is more likely to suffer from acne[1].

Regional Market Dynamics

Asia Pacific

The Asia Pacific region is a key market for acne drugs, including ACANYA. With a high prevalence of acne among adolescents and increasing healthcare expenditure, this region is expected to drive significant growth in the market[4].

Online Pharmacies

The growth of online pharmacies is also a regional trend, particularly in areas with high internet connectivity and consumer awareness. This channel provides easy access to acne treatments, contributing to the overall market growth[4].

Challenges and Opportunities

Regulatory Environment

Companies in the acne drugs market must navigate a complex regulatory environment. Regulatory approvals and compliance with health, safety, and environmental standards are crucial for market success[5].

Competitive Landscape

The market is competitive, with several key players vying for market share. Companies like Bausch Health, known for their strategic acquisitions and price adjustments, play a significant role in shaping the market dynamics[5].

Key Takeaways

• The global acne drugs market is growing steadily, driven by increasing acne prevalence, lifestyle changes, and rising skin awareness.
• The market is expected to reach $7.3 billion by 2028, with a CAGR of 4.5%.
• ACANYA, a clindamycin phosphate and benzoyl peroxide gel, benefits from growing demand for personalized skincare solutions and advancements in drug delivery technologies.
• Online pharmacies and social media marketing are key trends driving market growth.
• The Asia Pacific region is a significant growth area due to high acne prevalence and increasing healthcare expenditure.

FAQs

1. What is the projected market size of the acne drugs market by 2028?

   • The acne drugs market is expected to reach $7.3 billion by 2028[1].

2. What are the key drivers of the acne drugs market?

   • Key drivers include increasing acne prevalence, lifestyle changes, rising skin awareness, and growing cosmetic concerns[4].

3. How is the clindamycin phosphate and benzoyl peroxide market expected to grow?

   • This market is projected to reach USD 0.39 billion by 2032, growing at a CAGR of 6.2%[3].

4. What role do online pharmacies play in the acne drugs market?

   • Online pharmacies are expected to register the fastest CAGR of 6.6% during the forecast period, driven by increased internet connectivity and consumer awareness[4].

5. Which region is expected to drive significant growth in the acne drugs market?

   • The Asia Pacific region is expected to register the fastest CAGR over the forecast period due to high acne prevalence and increasing healthcare expenditure[4].

Sources

1. The Business Research Company. Global Acne Drugs Market Report 2024.
2. Blueprint Medicines. Blueprint Medicines Reports Fourth Quarter and Full Year 2022 Results.
3. Business Research Insights. Clindamycin Phosphate and Benzoyl Peroxide Market 2032.
4. Grand View Research. Acne Drugs Market Size, Share And Trends Report, 2030.
5. Wikipedia. Bausch Health.