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. Sixteen 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 six 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
Padagis LLC	Phase 3

See all ACANYA clinical trials

Pharmacology for ACANYA

Drug Class	Lincosamide Antibacterial
Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

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	8,288,434		Y
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	10,624,918
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	8,895,070
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	10,220,049		Y
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	9,078,870		Y
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	8,663,699

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	5,733,886
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	6,117,843

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
Portugal	2299810
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.)
South Korea	20110014651	TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT
Japan	6006272
Portugal	626844
Brazil	PI0913326	formulações farmacêuticas tópicas contendo uma baixa concentração de peróxido de benzoíla em suspensão aquosa e um solvente orgânico miscível em água

Supplementary Protection Certificates for ACANYA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122008000041	Germany		PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1586316	SPC/GB11/054	United Kingdom		PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
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
1586316	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ACANYA

Last updated: July 28, 2025

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Introduction

ACANYA, the brand name for acetaminophen (also known as paracetamol), is a globally recognized analgesic and antipyretic medication. This article provides a comprehensive analysis of the market dynamics influencing ACANYA and projects its financial trajectory based on current industry trends, competitive landscape, regulatory environment, and healthcare demands. As a widely used over-the-counter (OTC) medication, ACANYA plays a crucial role within the global pharmaceutical industry, which is characterized by steady demand, evolving consumer preferences, and rising regulatory scrutiny.

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Market Overview

The global acetaminophen market is driven by its proven efficacy, affordability, safety profile when used appropriately, and extensive application in pain management and fever reduction. The compounded demand stems from a broad spectrum of consumers, ranging from pediatric populations to adults, as well as institutional use in hospitals and clinics. In 2022, the global analgesics market was valued at approximately $15 billion, with acetaminophen accounting for a significant share due to its widespread availability and continuous demand.

Market size and growth:
The acetaminophen segment’s global valuation surpassed $2.5 billion in 2022, with forecasts projecting an annual Compound Annual Growth Rate (CAGR) of around 3-4% through 2028. This was buoyed by increasing health awareness, aging populations, and the growing prevalence of chronic pain conditions.

Regional dynamics:
North America remains the dominant market, attributed to high OTC drug consumption, robust healthcare infrastructure, and strong regulatory support. Asia-Pacific exhibits rapid growth potential, driven by expanding healthcare access, urbanization, and population size—particularly in countries like China and India. Europe demonstrates steady growth, with a focus on regulatory compliance and product innovation.

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Key Market Drivers

1. Rising Incidence of Chronic Pain and Fever-Related Conditions
The global rise in chronic and acute pain, fueled by aging populations and sedentary lifestyles, perpetuates ongoing demand. Additionally, febrile illnesses, notably influenza and COVID-19, sustain ACANYA’s relevance as a first-line fever reducer.

2. Consumer Preference for OTC Medications
Preference for accessible, cost-effective remedies intensifies the demand for widely available drugs like acetaminophen, especially as self-medication becomes increasingly common globally.

3. Expanding Pharmaceutical and Consumer Healthcare Markets
Growth in both prescription and OTC channels, complemented by innovations in formulation (e.g., age-specific formulations, combination products), sustains market growth.

4. Regulatory Environment and Safety Regulations
The regulatory landscape shapes market dynamics. Agencies like the FDA and EMA impose restrictions on maximum dosing due to hepatotoxicity risks. However, clear standards support consumer confidence and industry stability.

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Market Challenges and Risks

1. Safety Concerns and Regulatory Scrutiny
The primary challenge stems from hepatotoxicity risks associated with overdose. Regulatory agencies have implemented stricter dosage limits and warning labels, which could influence consumer perception and sales volume.

2. Competition from Alternative Analgesics
The market faces competition from NSAIDs (e.g., ibuprofen, naproxen) and newer analgesic agents, the latter often marketed with claims of fewer side effects, potentially eroding ACANYA's market share.

3. Supply Chain Disruptions
Global supply chains for raw materials, particularly in manufacturing active pharmaceutical ingredients (APIs), may encounter disruptions, affecting production and availability.

4. Patent and Market Entry Barriers
While acetaminophen itself is off-patent, formulation innovations and combination therapies may face patent challenges, limiting exclusivity.

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Competitive Landscape

Major players include Johnson & Johnson, McNeil Consumer Healthcare, Himalaya Drug Company, and local generic manufacturers. These firms leverage manufacturing scale, branding, and distribution networks to maintain competitiveness. Growing trends in product differentiation—such as flavoring, combination formulations, and specialized delivery systems—serve as key strategies to secure market share.

Generic dominance prevails due to the drug’s off-patent status, leading to price competition and pressure on profit margins. Brand loyalty, however, provides a degree of resilience for established companies.

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Regulatory and Policy Impact

Global regulatory agencies’ focus on hepatotoxicity has catalyzed the formulation of dosage guidelines and public health advisories. The U.S. FDA’s recommendations for maximum daily doses and initiatives like “Limit the Maximum Dose” campaigns influence manufacturer formulations and marketing. Countries also enforce packaging requirements to prevent accidental overdose.

In emerging markets, regulatory frameworks are evolving, aligning with international safety standards, which can delay market penetration but ultimately elevate product credibility.

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Financial Trajectory and Future Outlook

The financial outlook for ACANYA is optimistic, with projected steady growth owing to sustained demand in primary markets. However, margins may face compression due to intense price competition and regulatory compliance costs.

Revenue Projections:

• 2023-2028 CAGR: Estimated 3-4%, driven by growth in emerging markets and new formulations.
• Market Penetration Strategies: Investing in formulation improvements (e.g., combination drugs with other analgesics), expanding OTC distribution channels, and engaging in digital marketing will be pivotal.

Profitability prospects:
Manufacturers’ focus on cost efficiencies and scale will underpin stable profit margins, but evolving safety standards could introduce additional compliance costs.

Impact of Innovation:
Development of non-hepatotoxic formulations and targeted delivery mechanisms (e.g., sustained-release tablets) could unlock new revenue streams, especially in pain management segments.

COVID-19 Influence:
While COVID-19 initially amplified demand for fever reducers like acetaminophen, the subsequent normalization has stabilized the market. Nonetheless, pandemic-induced supply chain disruptions highlighted the importance of resilient manufacturing and distribution networks.

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Conclusion

ACANYA's enduring market presence is anchored in its affordability, proven efficacy, and broad applicability. Its market dynamics reflect a balance of steady global demand, regulatory safeguards, and competitive challenges. The projected financial trajectory remains positive, conditioned on innovation, strategic regulation compliance, and market diversification.

Manufacturers who capitalize on emerging markets, invest in safe formulation enhancements, and adapt to evolving regulatory standards will likely sustain growth and profitability. Monitoring safety messaging, competitive shifts, and regulatory modifications remains crucial for stakeholders aiming to maximize ACANYA's market potential.

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Key Takeaways

• Steady Growth: The global acetaminophen market complements broader analgesic trends, with a forecasted CAGR of 3-4% through 2028.
• Regulatory Impact: Increasing safety regulations focus on dosage limits, influencing formulations, marketing, and consumer perception.
• Market Expansion: Emerging markets and innovation in formulations offer substantial growth opportunities.
• Competitive Dynamics: Price competition among generics and branding strategies shape profitability.
• Supply Chain Resilience: Ensuring supply chain robustness is vital amid global disruptions.

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FAQs

1. What factors are most likely to influence ACANYA's future market growth?
Market growth will be driven by expanding healthcare access in emerging economies, product innovation, and effective regulatory compliance, especially as safety measures become more stringent.

2. How does regulatory scrutiny affect acetaminophen manufacturers?
Regulatory agencies impose dosage restrictions and labeling requirements to mitigate hepatotoxicity risks, which may increase manufacturing costs and affect marketing strategies.

3. Are there any emerging competitors to acetaminophen?
Yes. NSAIDs and newer pain management drugs, including topical and non-hepatotoxic formulations, are competing options that could impact ACANYA's market share.

4. How significant is the role of innovation in maintaining ACANYA’s market relevance?
Innovation is crucial—developing safer formulations, combination products, and novel delivery systems can differentiate offerings and meet evolving safety standards and consumer preferences.

5. What strategies should manufacturers pursue to capitalize on ACANYA's market potential?
Focus on expanding into high-growth regions, invest in formulation technologies, streamline supply chains, and engage in strategic branding and consumer education to foster trust and loyalty.

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Sources
[1] Global Analgesics Market Report, 2022.
[2] US Food and Drug Administration (FDA) guidelines on acetaminophen.
[3] Industry analysis of OTC pharmaceutical trends, 2023.