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Last Updated: July 13, 2020

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ONEXTON Drug Profile


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When do Onexton patents expire, and what generic alternatives are available?

Onexton 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 eighteen patent family members in twelve countries.

The generic ingredient in ONEXTON 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.

US ANDA Litigation and Generic Entry Outlook for Onexton

There has been one patent litigation case 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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Drug patent expirations by year for ONEXTON
Drug Prices for ONEXTON

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Drug Sales Revenue Trends for ONEXTON

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Recent Clinical Trials for ONEXTON

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SponsorPhase
Derm Research, PLLCPhase 4
Actavis Inc.Phase 3
Taro Pharmaceuticals USAPhase 1

See all ONEXTON clinical trials

Pharmacology for ONEXTON
Paragraph IV (Patent) Challenges for ONEXTON
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 ONEXTON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ONEXTON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0526708 C300097 Netherlands   Start Trial 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 C01458369/01 Switzerland   Start Trial PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369 SPC/GB10/005 United Kingdom   Start Trial PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
0137963 97C0042 Belgium   Start Trial PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
McKinsey
AstraZeneca
Mallinckrodt
McKesson
Baxter

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.