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ONEXTON Drug Profile

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Which patents cover Onexton, and what substitute generic drugs 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 sixteen 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. Nine suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

Summary for Tradename: ONEXTON

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list1
Clinical Trials: see list2
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ONEXTON at DailyMed

Pharmacology for Tradename: ONEXTON

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dow Pharm
ONEXTON
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-002Nov 24, 2014RXYesYes8,288,434► SubscribeY ► Subscribe
Dow Pharm
ONEXTON
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-002Nov 24, 2014RXYesYes9,561,208► SubscribeY ► Subscribe
Dow Pharm
ONEXTON
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-002Nov 24, 2014RXYesYes9,504,704► SubscribeY ► Subscribe
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Expired Patents for Tradename: ONEXTON

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dow Pharm
ONEXTON
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-002Nov 24, 20145,733,886► Subscribe
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Paragraph IV activity for: ONEXTON

Drugname Dosage Strength RLD Submissiondate
clindamycin phosphate and benzoyl peroxideGel1.2%/3.75%Onexton9/30/2015

Non-Orange Book Patents for Tradename: ONEXTON

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,663,699Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent► Subscribe
8,895,070Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent► Subscribe
9,078,870Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ONEXTON

Country Document Number Estimated Expiration
Russian Federation2493847► Subscribe
Australia2009255679► Subscribe
South Korea20110014651► Subscribe
Japan2011522820► Subscribe
Japan2015038093► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ONEXTON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00097Netherlands► SubscribePRODUCT 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
C/GB10/005United Kingdom► SubscribePRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
C/GB05/030United Kingdom► SubscribePRODUCT 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
C0042Belgium► SubscribePRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
172Luxembourg► SubscribePRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
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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 verifification 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.

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