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: November 18, 2019

DrugPatentWatch Database Preview

Canagliflozin; metformin hydrochloride - Generic Drug Details

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What are the generic drug sources for canagliflozin; metformin hydrochloride and what is the scope of patent protection?

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 and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Canagliflozin; metformin hydrochloride has two hundred and twenty-seven patent family members in forty-five countries.

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

Recent Clinical Trials for canagliflozin; metformin hydrochloride

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SponsorPhase
The University of Texas Health Science Center at San AntonioPhase 4
Medanta, The Medicity, IndiaN/A
MedImmune LLCPhase 2

See all canagliflozin; metformin hydrochloride clinical trials

Recent Litigation for canagliflozin; metformin hydrochloride

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District Court Litigation
Case NameDate
MITSUBISHI TANABE PHARMA CORPORATION v. MSN LABORATORIES PRIVATE LTD.2019-10-14
MITSUBISHI TANABE PHARMA CORPORATION v. LUPIN LIMITED2019-02-27
MITSUBISHI TANABE PHARMA CORPORATION v. LUPIN LIMITED2018-01-09

See all canagliflozin; metformin hydrochloride litigation

PTAB Litigation
PetitionerDate
Endo Pharmaceutical Inc.2014-04-17

See all canagliflozin; metformin hydrochloride litigation

Pharmacology for canagliflozin; metformin hydrochloride
Paragraph IV (Patent) Challenges for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
INVOKAMET XR TABLET, EXTENDED RELEASE;ORAL canagliflozin; metformin hydrochloride 205879 2018-11-21
INVOKAMET TABLET;ORAL canagliflozin; metformin hydrochloride 204353 2017-03-29

US Patents and Regulatory Information for canagliflozin; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-001 Sep 20, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-003 Aug 8, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-004 Sep 20, 2016 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 canagliflozin; metformin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1651658 PA2014008 Lithuania   Start Trial PRODUCT 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
1651658 C20140011 00102 Estonia   Start Trial PRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013
1651658 CA 2014 00024 Denmark   Start Trial PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
AstraZeneca
Moodys
McKinsey
Baxter

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.