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
Summary for NESINA
International Patents: | 69 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 63 |
Clinical Trials: | 14 |
Patent Applications: | 367 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NESINA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NESINA |
What excipients (inactive ingredients) are in NESINA? | NESINA excipients list |
DailyMed Link: | NESINA at DailyMed |


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
Sponsor | Phase |
---|---|
Sanofi | Phase 4 |
Takeda Development Center Americas, Inc. | Phase 3 |
Kun-Ho Yoon | Phase 4 |
Pharmacology for NESINA
Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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
Expired US Patents for NESINA
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 | 022271-001 | 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 |
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 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 |