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Last Updated: January 28, 2020

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KAZANO Drug Profile

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When do Kazano patents expire, and what generic alternatives are available?

Kazano is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eight patent family members in forty countries.

The generic ingredient in KAZANO is alogliptin benzoate; metformin hydrochloride. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alogliptin benzoate; metformin hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Kazano

Kazano was eligible for patent challenges on January 25, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 24, 2029. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for KAZANO
Drug Prices for KAZANO

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Generic Entry Opportunity Date for KAZANO
Generic Entry Date for KAZANO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for KAZANO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
TakedaPhase 3

See all KAZANO clinical trials

Recent Litigation for KAZANO

Identify potential future generic entrants

District Court Litigation
Case NameDate
TAKEDA PHARMACEUTICAL COMPANY LTD. v. INDOCO REMEDIES LTD.2018-01-03
TAKEDA PHARMACEUTICAL COMPANY LTD. v. INDOCO REMEDIES LTD.2017-09-20
TAKEDA PHARMACEUTICAL COMPANY LTD. v. TORRENT PHARMACEUTICALS LTD.2017-05-05

See all KAZANO litigation

Pharmacology for KAZANO
Synonyms for KAZANO
Alogliptin / metformin
Alogliptin / metformin hydrochloride
Alogliptin and metformin hydrochloride
Alogliptin mixture with metformin
Alogliptin mixture with metformin hydrochloride
S900006100
SYR-322 + metformin hydrochloride
Paragraph IV (Patent) Challenges for KAZANO
Tradename Dosage Ingredient NDA Submissiondate
KAZANO TABLET;ORAL alogliptin benzoate; metformin hydrochloride 203414 2017-01-25

US Patents and Regulatory Information for KAZANO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No   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

Expired US Patents for KAZANO

Supplementary Protection Certificates for KAZANO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586571 CR 2014 00011 Denmark   Start Trial PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130923
1586571 172 5006-2014 Slovakia   Start Trial PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130919
1586571 PA2014011 Lithuania   Start Trial PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844 20130919
1586571 2014/012 Ireland   Start Trial PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1586571 C20140007 00126 Estonia   Start Trial PRODUCT NAME: ALOGLIPTIIN;REG NO/DATE: EU/1/13/844 23.09.2013
1586571 CA 2014 00011 Denmark   Start Trial PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130919
1586571 122014000019 Germany   Start Trial PRODUCT NAME: VIPIDIA - ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
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Colorcon
Express Scripts
Boehringer Ingelheim
Merck

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