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Harvard Business School
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Baxter
Merck

Last Updated: October 20, 2019

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ONEXTON Drug Profile

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When do Onexton patents expire, and when can generic versions of Onexton launch?

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 seventeen patent family members in eleven 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.

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

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

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

See all ONEXTON clinical trials

Recent Litigation for ONEXTON

Identify potential future generic entrants

District Court Litigation
Case NameDate
DOW PHARMACEUTICAL SCIENCES, INC. v. TARO PHARMACEUTICALS U.S.A., INC.2016-01-12

See all ONEXTON litigation

Pharmacology for ONEXTON
Synonyms for ONEXTON
Benzoyl peroxide mixture with Clindamycin phosphate
Benzoyl peroxide, clindamycin drug combination
Clindamycin mixt. with benzoyl peroxide
Clindamycin phosphate and benzoyl peroxide
Clindoxyl gel
DUAC gel
L-threo-.alpha.-D-galacto-Octopyranoside, methyl 7-chloro-6,7,8-trideoxy-6-((((2S,4R)-1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-, 2-(dihydrogen phosphate), mixt. with dibenzoyl peroxide
SCHEMBL15568161

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
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
Paragraph IV (Patent) Challenges for ONEXTON
Drugname Dosage Strength RLD Date
➤ Subscribe Gel 1.2%/3.75% ➤ Subscribe   Start Trial

Supplementary Protection Certificates for ONEXTON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0137963 97C0042 Belgium   Start Trial PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
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
1458369 CA 2008 00029 Denmark   Start Trial PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1586316 SPC/GB11/054 United Kingdom   Start Trial 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
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
0591275 SPC/GB05/030 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Merck
Dow
McKinsey
Medtronic

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