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Last Updated: June 13, 2021

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ACANYA Drug 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 and two Paragraph IV challenges.

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. Thirteen 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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Paragraph IV (Patent) Challenges for ACANYA
Tradename Dosage Ingredient NDA Submissiondate
ONEXTON GEL;TOPICAL benzoyl peroxide; clindamycin phosphate 050819 2015-09-30
ACANYA GEL;TOPICAL benzoyl peroxide; clindamycin phosphate 050819 2015-09-30
ACANYA GEL;TOPICAL benzoyl peroxide; clindamycin phosphate 050819 2012-12-20
ONEXTON GEL;TOPICAL benzoyl peroxide; clindamycin phosphate 050819 2012-12-20

US Patents and Regulatory Information for ACANYA

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   Get Started Free   Get Started Free Y   Get Started Free
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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   Get Started Free   Get Started Free
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ACANYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1667986 92172 Luxembourg   Get Started Free 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)
1458369 122008000041 Germany   Get Started Free 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   Get Started Free PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
0137963 97C0042 Belgium   Get Started Free PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
0526708 C300097 Netherlands   Get Started Free 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
>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

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