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: October 20, 2019

DrugPatentWatch Database Preview

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 seven patent family members in thirty-nine 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.

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

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SponsorPhase
TakedaPhase 3

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Recent Litigation for KAZANO

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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

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
>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

Paragraph IV (Patent) Challenges for KAZANO
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 12.5 mg/500 mg and 12.5 mg/1000 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for KAZANO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 CR 2014 00066 Denmark   Start Trial PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923
1586571 92374 Luxembourg   Start Trial PRODUCT NAME: ALOGLIPTIN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130923
1586571 1490014-6 Sweden   Start Trial PERIOD OF VALIDITY (FROM - UNTIL): 2024-12-22 TILL - 2028-09-22
1084705 PA2014045 Lithuania   Start Trial PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1586571 C300640 Netherlands   Start Trial PRODUCT NAME: ALOGLIPTINE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/13/844/001-007 20130923
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
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Mallinckrodt
McKinsey
Moodys

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.