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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Citi
Moodys
Farmers Insurance
Queensland Health
Fish and Richardson
Express Scripts
Teva
Deloitte

Generated: December 18, 2018

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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 Dow Pharm and is included in one NDA. There are three 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. Ten 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
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
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

Supplementary Protection Certificates for ONEXTON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008000041 Germany ➤ Sign Up PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369/01 Switzerland ➤ Sign Up PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
C/GB11/054 United Kingdom ➤ Sign Up 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
00097 Netherlands ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Citi
Moodys
Farmers Insurance
Queensland Health
Fish and Richardson
Express Scripts
Teva
Deloitte

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