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Last Updated: August 11, 2022

ACANYA Drug Patent Profile


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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

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US Patents and Regulatory Information for ACANYA

ACANYA is protected by six US patents.

Patents protecting ACANYA

Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER

Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER

Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

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

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

Patent: 09255679
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0913326
Estimated Expiration: See Plans and Pricing

Canada

Patent: 23029
Estimated Expiration: See Plans and Pricing

China

Patent: 2056481
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0200450
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 99810
Estimated Expiration: See Plans and Pricing

Japan

Patent: 77693
Estimated Expiration: See Plans and Pricing

Patent: 06272
Estimated Expiration: See Plans and Pricing

Patent: 11522820
Estimated Expiration: See Plans and Pricing

Patent: 15038093
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10013152
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 99810
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 93847
Estimated Expiration: See Plans and Pricing

Patent: 45087
Estimated Expiration: See Plans and Pricing

Patent: 10146038
Estimated Expiration: See Plans and Pricing

Patent: 13122395
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1008265
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 110014651
Estimated Expiration: See Plans and Pricing

Spain

Patent: 73931
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
Japan H07504168 See Plans and Pricing
Spain 2153377 See Plans and Pricing
Spain 2773931 See Plans and Pricing
Canada 2723029 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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ACANYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0591275 SPC/GB05/030 United Kingdom See Plans and Pricing 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
0137963 97C0042 Belgium See Plans and Pricing PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
1458369 122008000041 Germany See Plans and Pricing PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369 SPC/GB10/005 United Kingdom See Plans and Pricing PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369 C01458369/01 Switzerland See Plans and Pricing PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Baxter
Dow
McKesson
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.