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Last Updated: December 12, 2024

Alogliptin benzoate - Generic Drug Details


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What are the generic drug sources for alogliptin benzoate and what is the scope of freedom to operate?

Alogliptin benzoate is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa and is included in three NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alogliptin benzoate has sixty-nine patent family members in thirty-seven countries.

There are ten drug master file entries for alogliptin benzoate. Five suppliers are listed for this compound. There are two tentative approvals for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for alogliptin benzoate
Generic Entry Date for alogliptin benzoate*:
Constraining patent/regulatory exclusivity:
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 alogliptin benzoate

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

SponsorPhase
Yonsei UniversityPhase 4
Celltrion Pharm, Inc.Phase 4
TakedaPhase 4

See all alogliptin benzoate clinical trials

Generic filers with tentative approvals for ALOGLIPTIN BENZOATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up6.25MGTABLET;ORAL
⤷  Sign Up⤷  Sign UpEQ 25MG BASETABLET;ORAL
⤷  Sign Up⤷  Sign UpEQ 12.5MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for alogliptin benzoate
Paragraph IV (Patent) Challenges for ALOGLIPTIN BENZOATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NESINA Tablets alogliptin benzoate 6.25 mg, 12.5 mg and 25 mg 022271 5 2017-01-25

US Patents and Regulatory Information for alogliptin benzoate

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-002 Jan 25, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-003 Jan 25, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-002 Jan 25, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-004 Jan 25, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-004 Jan 25, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 alogliptin benzoate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for alogliptin benzoate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharma A/S Vipidia alogliptin benzoate EMEA/H/C/002182
Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Authorised no no no 2013-09-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for alogliptin benzoate

Country Patent Number Title Estimated Expiration
Luxembourg 92374 ⤷  Sign Up
Taiwan 200531695 Dipeptidyl peptidase inhibitors ⤷  Sign Up
Israel 220480 נגזרות 1-בנזיל-פירימידין-2,4-דיאון כמעכבי דיפפטידיל פפטידאז, שיטה להכנתן, תכשירים רוקחיים המכילים אותן , ושימוש בהן להכנת תרופות (1-benzyl-pyrimidine-2,4-dione derivatives as dipeptidyl peptidase inhibitors, preparation method thereof, pharmaceutical compositions comprising them and use thereof in the preparation of medicaments) ⤷  Sign Up
Japan 4068118 ⤷  Sign Up
Japan 2007314551 DIPEPTIDYL-PEPTIDASE INHIBITOR ⤷  Sign Up
Brazil PI0418639 inibidores de dipeptidil peptidase ⤷  Sign Up
Eurasian Patent Organization 013427 ИНГИБИТОРЫ ДИПЕПТИДИЛПЕПТИДАЗЫ (DIPEPTIDYL PEPTIDASE INHIBITORS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for alogliptin benzoate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586571 CR 2014 00011 Denmark ⤷  Sign Up PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130923
1586571 1490014-6 Sweden ⤷  Sign Up PERIOD OF VALIDITY (FROM - UNTIL): 20241222 - 20280922
1586571 172 5006-2014 Slovakia ⤷  Sign Up PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130919
1586571 92374 Luxembourg ⤷  Sign Up PRODUCT NAME: ALOGLIPTIN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130923
1586571 2014/012 Ireland ⤷  Sign Up PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1084705 CR 2014 00066 Denmark ⤷  Sign Up PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923
1586571 2014C/010 Belgium ⤷  Sign Up PRODUCT NAME: ALOGLIPTINE (EN TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/844/001 20130923
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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