Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 15, 2019

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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 five patents protecting this drug and one Paragraph IV challenge.

This drug has seventeen patent family members in eleven 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.

US ANDA Litigation and Generic Entry Outlook for Acanya

Acanya was eligible for patent challenges on December 31st, 1968.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.

Drug patent expirations by year for ACANYA
Drug Prices for ACANYA

See drug prices for ACANYA

Drug Sales Revenue Trends for ACANYA

See drug sales revenues for ACANYA

Recent Clinical Trials for ACANYA

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

SponsorPhase
Taro Pharmaceuticals USAPhase 1
Watson Laboratories, Inc.Phase 3
Perrigo CompanyPhase 3

See all ACANYA clinical trials

Recent Litigation for ACANYA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Amgen Inc. v. Accord Healthcare, Inc.2018-06-28
DOW PHARMACEUTICAL SCIENCES, INC. v. TARO PHARMACEUTICALS U.S.A., INC.2016-01-12
DOW PHARMACEUTICAL SCIENCES, INC. v. TOLMAR, INC.2015-11-09

See all ACANYA litigation

Pharmacology for ACANYA
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
ONEXTON GEL;TOPICAL benzoyl peroxide; clindamycin phosphate 050819 2012-12-20
ACANYA 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   Start Trial   Start Trial Y   Start Trial
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008   Start Trial   Start Trial
>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
1586316 122011100019 Germany   Start Trial PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
0186118 SPC/GB05/029 United Kingdom   Start Trial PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
1458369 CA 2008 00029 Denmark   Start Trial PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369 122008000041 Germany   Start Trial PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
0137963 97C0042 Belgium   Start Trial PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
1458369 C01458369/01 Switzerland   Start Trial 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:

Dow
AstraZeneca
Colorcon
McKesson
McKinsey
Express Scripts

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 verifification 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.