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. Five 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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Summary for NESINA
| International Patents: | 69 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Clinical Trials: | 14 |
| Patent Applications: | 265 |
| 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 Loss of Exclusivity (LOE) Date for NESINA
*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 |
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 and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NESINA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
Dipeptidyl peptidase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
Dipeptidyl peptidase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tablet preparation without causing a tableting trouble
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting NESINA
REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY SYR-322-309, CONDUCTED IN RESPONSE TO A PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | 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 | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-001 | Jan 25, 2013 | RX | 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 NESINA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-003 | 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 |
| >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
Patent: PREPARACION SOLIDA
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 77193
Patent: PREPARATION DE COMPRIME NE PROVOQUANT PAS DE PROBLEME DE PASTILLAGE (TABLET PREPARATION WITHOUT CAUSING A TABLETING TROUBLE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 08000280
Patent: COMPOSICION FARMACEUTICA EN FORMA DE COMPRIMIDO QUE CONTIENE UN GRANULO QUE COMPRENDE UN PRINCIPIO ACTIVO QUE INDUCE FACILMENTE A UN PROBLEMA EN LA COMPRESION Y CELULOSA MICROCRISTALINA Y UN AUXILIAR DE COMPRESION QUE CONTIENE ESTEARATO DE MAGNESIO Y
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0171518
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 24901
Patent: PRÉPARATION DE COMPRIMÉ NE PROVOQUANT PAS DE PROBLÈME DE PASTILLAGE (TABLET PREPARATION WITHOUT CAUSING A TABLETING TROUBLE)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 84967
Estimated Expiration: ⤷ Sign Up
Patent: 10517936
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 081734
Patent: COMPRIMIDO QUE COMPRENDE 2-[[6-[(3R)-3-AMINO-1-PIPERIDINIL]-3,4-DIHIDRO-3-METIL-2,4-DIOXO-1(2H)-PIRIMIDINIL]METIL]-BENZONITRILO Y CELULOSA MICROCRISTALINA
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 39854
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 0836774
Patent: Solid preparation
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| China | 1132578 | ⤷ Sign Up | |
| Russian Federation | 2003130978 | ⤷ Sign Up | |
| China | 102134231 | Dipeptidyl peptidase inhibitors | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NESINA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1174135 | SPC026/2009 | Ireland | ⤷ Sign Up | SPC026/2009: 20101001, EXPIRES: 20210619 |
| 1084705 | C01084705/02 | Switzerland | ⤷ Sign Up | PRODUCT NAME: VILDAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57834 30.04.2008 |
| 1084705 | CA 2014 00065 | Denmark | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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