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Last Updated: November 26, 2022

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. Three suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for alogliptin benzoate

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

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

See all alogliptin benzoate clinical trials

Generic filers with tentative approvals for ALOGLIPTIN BENZOATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing6.25MGTABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 25MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 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 203414-001 Jan 25, 2013 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-005 Jan 25, 2013 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 022271-002 Jan 25, 2013 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 Jan 25, 2013 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 Jan 25, 2013 See Plans and Pricing See Plans and Pricing
>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

Supplementary Protection Certificates for alogliptin benzoate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586571 252 5006-2014 Slovakia See Plans and Pricing PRODUCT NAME: ALOGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130923
1586571 C20140007 00126 Estonia See Plans and Pricing PRODUCT NAME: ALOGLIPTIIN;REG NO/DATE: EU/1/13/844 23.09.2013
1586571 132014902238640 Italy See Plans and Pricing PRODUCT NAME: ALOGLIPTIN IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(VIPIDIA); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/13/844/001 A EU/1/13/844/027, 20130923
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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