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Last Updated: August 11, 2022

NESINA Drug Patent Profile


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Which patents cover Nesina, and what generic alternatives are available?

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

This drug has sixty-nine patent family members in thirty-seven countries.

The generic ingredient in NESINA is alogliptin benzoate. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the alogliptin benzoate profile page.

DrugPatentWatch® Generic Entry Outlook for Nesina

Nesina 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 June 16, 2029. This may change due to patent challenges or generic licensing.

There have been five 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.

There are two tentative approvals for the generic drug (alogliptin benzoate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for NESINA
Drug Prices for NESINA

See drug prices for NESINA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for NESINA
Generic Entry Date for NESINA*:
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 NESINA

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

SponsorPhase
SanofiPhase 4
Takeda Development Center Americas, Inc.Phase 3
Kun-Ho YoonPhase 4

See all NESINA clinical trials

Pharmacology for NESINA
Paragraph IV (Patent) Challenges for NESINA
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 NESINA

NESINA is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NESINA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NESINA

Dipeptidyl peptidase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN

Dipeptidyl peptidase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN

Dipeptidyl peptidase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tablet preparation without causing a tableting trouble
Patent Number: See Plans and Pricing
Patent Expiration: 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
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 RX Yes No See Plans and Pricing See Plans and Pricing 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 NESINA alogliptin benzoate TABLET;ORAL 022271-001 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 022271-003 Jan 25, 2013 RX Yes Yes 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 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 NESINA

EU/EMA Drug Approvals for NESINA

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 NESINA

When does loss-of-exclusivity occur for NESINA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5096
Estimated Expiration: See Plans and Pricing

Canada

Patent: 77193
Estimated Expiration: See Plans and Pricing

Chile

Patent: 08000280
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0171518
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 24901
Estimated Expiration: See Plans and Pricing

Japan

Patent: 84967
Estimated Expiration: See Plans and Pricing

Patent: 10517936
Estimated Expiration: See Plans and Pricing

Peru

Patent: 081734
Estimated Expiration: See Plans and Pricing

Spain

Patent: 39854
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 0836774
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NESINA around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 9740832 See Plans and Pricing
Australia 2003264609 See Plans and Pricing
Austria 256463 See Plans and Pricing
Luxembourg 91606 See Plans and Pricing
China 1926128 Dipeptidyl peptidase inhibitors See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NESINA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0861666 CA 2007 00001 Denmark See Plans and Pricing
1586571 PA2014011,C1586571 Lithuania See Plans and Pricing PRODUCT NAME: ALOGLIPTINAS; REGISTRATION NO/DATE: EU/1/13/844 20130919
1586571 2014/012 Ireland See Plans and Pricing PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
0896538 08C0008 France See Plans and Pricing PRODUCT NAME: VILDAGLIPTINE OU UN DE SES SELS PHARMACETIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/414/001 DU 20070926; REGISTRATION NO/DATE AT EEC: EU/1/07/414/001-017 DU 20070926
1084705 SPC/GB14/082 United Kingdom See Plans and Pricing PRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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 verification 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.