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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Federal Trade Commission
Julphar
McKinsey
Fuji
Covington

Generated: March 24, 2019

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ONEXTON Drug Profile

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Which patents cover Onexton, and when can generic versions of Onexton launch?

Onexton is a drug marketed by Dow Pharm and is included in one NDA. There are four 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. Eleven 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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 ➤ Try a Free Trial

International Patents for ONEXTON

Supplementary Protection Certificates for ONEXTON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0137963 97C0042 Belgium ➤ Try a Free Trial PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
1458369 SPC/GB10/005 United Kingdom ➤ Try a Free Trial PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369 122008000041 Germany ➤ Try a Free Trial PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
0186118 SPC/GB05/029 United Kingdom ➤ Try a Free 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 ➤ Try a Free Trial PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369 C01458369/01 Switzerland ➤ Try a Free 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 hundreds of leading biopharmaceutical companies globally:

McKesson
Colorcon
Harvard Business School
Daiichi Sankyo
Fuji
Chinese Patent Office

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