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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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 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. 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 Onexton

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

There has been one patent litigation case 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 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
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
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
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
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:

McKinsey
Johnson and Johnson
Dow
Harvard Business School
Medtronic
Express Scripts

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