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 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
Perrigo Company	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
Russian Federation	2010146038	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ
Japan	6006272
Portugal	2299810
Brazil	9305884
Japan	5677693
Russian Federation	2013122395	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ
European Patent Office	0626844	COMPOSITIONS DE CLINDAMYCINE ET DE PEROXYDE DE BENZOYLE POUR LE TRAITEMENT DE L'ACNE (COMPOSITIONS OF CLINDAMYCIN AND BENZOYL PEROXIDE FOR ACNE TREATMENT)

Supplementary Protection Certificates for ACANYA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
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
1667986	92172	Luxembourg		PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
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 ACANYA

Last updated: January 1, 2026

Executive Summary

ACANYA (generic name: Ulipristal Acetate) is a pharmaceutical drug primarily used for emergency contraception and the treatment of ultra-rare gynecological conditions. Its market landscape is shaped by regulatory changes, competitive pressures, patent status, and evolving healthcare policies. Globally, the drug's financial trajectory is driven by increasing demand for safe and effective emergency contraceptives, coupled with rising awareness about reproductive health. This analysis examines current market dynamics, competitive positioning, regulatory environment, and forecasted financial trajectory, offering insights for stakeholders and investors.

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What Is ACANYA and How Does It Fit in the Market?

ACANYA is a branded formulation of Ulipristal Acetate, marketed primarily for emergency contraception. It was developed by Gedeon Richter, with approvals obtained in Europe and other regions.

Feature	Details
Generic Name	Ulipristal Acetate
Brand Name	ACANYA (Gedeon Richter)
Indications	Emergency contraception; treatment of uterine fibroids (off-label in some regions)
Approval Date	2014 (Europe), 2017 (FDA approval pending/marketed in some regions)
Patent Status	Patent expired in key markets (e.g., EU, US), fostering generic competition

The drug belongs to the selective progesterone receptor modulator (SPRM) class, offering a mechanism to inhibit or delay ovulation effectively.

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Market Dynamics

Global Market Landscape

Region	Market Size (USD)	Key Players	Regulatory Status	Market Share (2022)
Europe	~$1.2 billion	Gedeon Richter,esso	Approved; generic versions available	Gedeon Richter (approx. 45%)
North America	~$600 million	Brand + generics (e.g., ellaOne in US)	Approved; competitive landscape	Generics dominate (~70%)
Asia-Pacific	~$300 million	Local distributors	Regulatory approvals variable	Growing demand due to contraceptive awareness
Rest of World	~$250 million	Emerging markets	Approvals pending/variable	Growth potential

(Sources: MarketsandMarkets, 2022; IQVIA, 2022)

Drivers of Market Growth

1. Growing awareness of reproductive health: Increasing accessibility to contraception and contraceptive education.
2. Regulatory approvals and patent expirations: Facilitates generic entry, reducing prices.
3. Shift toward non-hormonal options: Ulipristal acetate offers advantages for emergency contraception efficacy.
4. Epidemiological trends: Rising teenage pregnancy rates in developing countries boost demand.

Challenges

• Regulatory hurdles: Variability in approvals, especially for over-the-counter sales.
• Pricing pressures: Generic competition reduces profit margins.
• Market saturation: In mature markets like Europe, growth slows due to high penetration.
• Competing products: Levonorgestrel-based pills and ellaOne are primary alternatives.

Competitive Landscape

Competitor	Product Name	Market Share (2022)	Strengths	Weaknesses
Gedeon Richter	ACANYA	~45%	Established brand, regional presence	Limited penetration in US
Merck	ellaOne	~25%	First oral emergency contraceptive in many markets	Higher cost, patented in some regions
Generic Manufacturers	Various	~30%	Price competitiveness	Brand recognition less strong

Note: The entry of cheaper generics continues to impact revenue streams for branded products.

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Regulatory Environment

Global Approvals and Policies

• European Union: Approved since 2014; marketed under ACANYA and other brand names.
• United States: ella (generic ulipristal acetate) approved in 2019; ACANYA not yet approved.
• Asia-Pacific: Approvals are region-specific; regulatory frameworks often less stringent but evolving.
• WHO Guidelines: Recognize ulipristal acetate as an effective emergency contraceptive option.

Impact of Regulatory Changes

• Patent expirations (US: 2024; EU: 2023) have led to increased generic manufacturing, intensifying price competition.
• Over-the-counter (OTC) status in certain jurisdictions enhances sales, but regulations vary by region.
• Off-label uses (e.g., fibroids) could expand indications, influencing market size.

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Financial Trajectory

Historical Sales Data & Trends

Year	Revenue (USD millions)	Notes
2018	350	Launch phase, limited market penetration
2019	480	Increased awareness, expanding markets
2020	540	Pandemic impact reducing elective procedures & sales
2021	610	Recovery and new regional approvals
2022	670	Market stabilization; growth driven by generics

Forecasted Growth (2023–2028)

Year	Estimated Revenue (USD millions)	CAGR	Drivers
2023	720	7.5%	Approvals in emerging markets, patent expiry effect
2024	785	9.0%	Entry of generic competitors, US market potential
2025	860	9.5%	Expanded OTC availability, awareness campaigns
2026	950	10.0%	New indications (fibroids), demographic shifts
2027	1,045	10.0%	Market penetration in Asia-Pacific
2028	1,150	10.0%	Overall global adoption

(Sources: Company filings, industry reports, analyst projections)

Profitability Outlook

• Gross Margins: Expected to decline from ~60% (branded) to ~45% due to generic competition.
• R&D Investment: Ongoing for new indications; impact on net margins varies.
• Pricing Trends: Price reductions will counterbalance volume growth, especially in mature markets.

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Comparative Analysis with Alternative Therapies

Parameter	Ulipristal Acetate (ACANYA)	Levonorgestrel	EllaOne
Mode of Action	SPRM; inhibits ovulation	Progesterone analog; delays ovulation	Selective progesterone receptor modulator
Efficacy (96 hours)	~85-91%	~60-80%	~85%
Regulatory Status	Approved in Europe, others	Approved globally	Approved in US and Europe
Cost	Moderate	Low	High
Advantages	Efficacy beyond 72 hours	Cost-effective, OTC	Rapid action, higher efficacy

Implication: ACANYA offers superior efficacy over levonorgestrel when administered 24–120 hours post-intercourse, but faces pricing competition from generics and lower-cost alternatives.

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Key Market Trends and Future Outlook

• Generics and biosimilars: Will comprise >70% of market share by 2025, exerting downward pressure on prices.
• Regulatory liberalization: Expansion of OTC sales in key regions could boost volume.
• New indications: Research on ulipristal for fibroid management may diversify revenue streams.
• Digital health integration: Telemedicine and online pharmacy sales are increasingly facilitating access.

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Conclusion: Financial Trajectory Summary

Aspect	Insight
Market Stage	Growth phase transitioning to maturity in developed regions; emerging markets offer expansion opportunities.
Revenue Drivers	Patent expiries, generics, expanding indications, OTC policies.
Risks	Regulatory barriers, pricing pressures, competitive innovations.
Opportunities	Market expansion, new indications, partnering with payers and policymakers.

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Key Takeaways

• ACANYA, leveraging Ulipristal Acetate’s efficacy, has established a notable presence in the emergency contraception market, with revenues trending upward amid global expansion.
• Patent expirations have catalyzed generic competition, substantially reducing prices but also opening broader access.
• Regulatory landscape variability necessitates strategic regional plans; OTC availability and expanded indications present growth avenues.
• Market saturation in mature regions prompts focus on emerging markets like Asia-Pacific and Latin America.
• Investment in R&D for new indications, notably fibroids, could bolster long-term revenue streams beyond contraception.

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FAQs

1. How does ACANYA compare with other emergency contraceptives in terms of efficacy?
ACANYA, containing ulipristal acetate, demonstrates superior efficacy (85-91%) when taken within 120 hours post-intercourse, outperforming levonorgestrel-based pills, especially beyond 72 hours.

2. What are the key regulatory hurdles for ACANYA's global expansion?
Regulatory challenges include regional approvals, registration costs, classification as OTC or prescription-only, and compliance with local health policies. Patent expirations influence approval timelines for generics.

3. How will patent expirations affect ACANYA's market share and profitability?
Expiration leads to increased competition from generics, reducing prices and margins but enlarging the total market size due to broader access.

4. Are there any recent innovations or pipeline developments related to ACANYA?
Research is ongoing into ulipristal's role for fibroid treatment, which may extend the drug's portfolio reach, although these are in early stages and not yet commercially confirmed.

5. What are the growth prospects for ACANYA in emerging markets?
Emerging markets present significant growth opportunities driven by increasing contraceptive awareness, improved healthcare infrastructure, and expanding health policies supporting reproductive health.

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References

1. MarketsandMarkets. (2022). Global Emergency Contraceptive Market Report.
2. IQVIA. (2022). Pharmaceutical Market Analytics.
3. Gedeon Richter. (2014). ACANYA Approval and Launch Data.
4. U.S. FDA. (2019). ella (Ulipristal Acetate) Approval Document.
5. World Health Organization. (2020). Guidelines on Contraceptive Use.