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Canagliflozin; metformin hydrochloride - Generic Drug Details

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Canagliflozin; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Janssen Pharms and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and ninety-nine patent family members in forty-one countries.

There are thirteen drug master file entries for canagliflozin; metformin hydrochloride. One supplier is listed for this compound.

Summary for Generic Name: canagliflozin; metformin hydrochloride

Tradenames:2
Patents:6
Applicants:1
NDAs:2
Drug Master File Entries: see list13
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: canagliflozin; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
INVOKAMET XR
canagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205879-004Sep 20, 2016RXYes7,943,788► subscribeYY ► subscribe
Janssen Pharms
INVOKAMET
canagliflozin; metformin hydrochloride
TABLET;ORAL204353-004Aug 8, 2014RXYes7,943,582► subscribeYY ► subscribe
Janssen Pharms
INVOKAMET XR
canagliflozin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205879-002Sep 20, 2016RXNo8,513,202► subscribeYY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: canagliflozin; metformin hydrochloride

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
7,511,020Substituted benzimidazole-, benztriazole-, and benzimidazolone-O-glucosides► subscribe
7,521,430N-glucoside compounds having an inhibitory activity against sodium-dependent glucose transporter► subscribe
7,511,022Substituted indole-O-glucosides► 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 Ingredient: canagliflozin; metformin hydrochloride

Country Document Number Estimated Expiration
Japan5225679► subscribe
Argentina045173► subscribe
World Intellectual Property Organization (WIPO)2006080577► 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: CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90027-8Sweden► subscribePRODUCT NAME: KANAGLIFLOZIN; REG. NO/DATE: EU/1/13/884/001 20131115
0140011 00102Estonia► subscribePRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013
2014008Lithuania► subscribePRODUCT NAME: CANAGLIFOZINUM; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/004, 2013 11 15 EU/1/13/884/005 - EU/1/13/884/008 20131115
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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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