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NESINA Drug 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 seven patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-eight patent family members in thirty-five 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.
US ANDA Litigation and Generic Entry Outlook for Nesina
Nesina was eligible for patent challenges on January 25th, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 16th, 2029. This may change due to patent challenges or generic licensing.
There have been four 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.
Summary for NESINA
| International Patents: | 88 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 54 |
| Clinical Trials: | 14 |
| Patent Applications: | 21 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NESINA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NESINA |
| DailyMed Link: | NESINA at DailyMed |
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 | Phase 4 |
| Kun-Ho Yoon | Phase 4 |
Recent Litigation for NESINA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| TAKEDA PHARMACEUTICAL COMPANY LTD. v. INDOCO REMEDIES LTD. | 2018-01-03 |
| TAKEDA PHARMACEUTICAL COMPANY LTD. v. INDOCO REMEDIES LTD. | 2017-09-20 |
| TAKEDA PHARMACEUTICAL COMPANY LTD. v. TORRENT PHARMACEUTICALS LTD. | 2017-05-05 |
Pharmacology for NESINA
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Synonyms for NESINA
| (3R)-1-[3-(2-cyanobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl]piperidin-3-aminium benzoate |
| (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile benzoate |
| 2-((6-((3R)-3-amino-1-piperidinyl)-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)- pyrimidinyl)methyl)benzonitrile monobenzoate |
| 2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile benzoate |
| 2-[[6-[(3R)-3-Amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]benzonitrile benzoate |
| 2-[[6-[(3R)-3-amino-1-piperidyl]-3-methyl-2,4-dioxo-pyrimidin-1-yl]methyl]benzonitrile; benzoic acid |
| 2-[[6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxopyrimidin-1-yl]methyl]benzonitrile;benzoic acid |
| 6-((3R)-3-aminopiperidin-1-yl)-1-(2-cyanobenzyl)-3-methylpyrimidin-2,4(1H,3H)-dione monobenzoate |
| 850649-62-6 |
| AB1008522 |
| AC-021 |
| AKOS015917686 |
| Alogliptin (Benzoate) |
| Alogliptin benzoate |
| Alogliptin benzoate (JAN/USAN) |
| Alogliptin benzoate [USAN:JAN] |
| alogliptin monobenzoate |
| Alogliptin, benzoate |
| Alogliptin?SYR-322 |
| AM20090704 |
| AN-6359 |
| API0004995 |
| AS-14073 |
| BC202597 |
| BCP08885 |
| Benzoic acid--2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile (1/1) |
| Benzonitrile, 2-((6-((3R)-3-amino-1-piperidinyl)-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl)methyl)-, monobenzoate |
| Benzonitrile, 2-[[6-[(3R)-3-amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-, benzoate (1:1) |
| Benzonitrile,2-[[6-[(3R)-3-amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-, monobenzoate |
| C18H21N5O2.C7H6O2 |
| CHEBI:72324 |
| CHEMBL227529 |
| CS-0761 |
| D06553 |
| DTXSID20582095 |
| EEN99869SC |
| FT-0686730 |
| HY-A0023 |
| I14-8828 |
| J90037 |
| MolPort-005-933-064 |
| Nesina (TN) |
| SCHEMBL476231 |
| SYR 322 |
| SYR 322 benzoate |
| SYR-322 |
| UNII-EEN99869SC |
| Vipidia (TN) |
| X4993 |
Paragraph IV (Patent) Challenges for NESINA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NESINA | TABLET;ORAL | alogliptin benzoate | 022271 | 2017-01-25 |
US Patents and Regulatory Information for NESINA
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-003 | Jan 25, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-003 | Jan 25, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-001 | Jan 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-001 | Jan 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-002 | Jan 25, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-003 | Jan 25, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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 | Start Trial | Start Trial |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-002 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-002 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-001 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-003 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-002 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-003 | Jan 25, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NESINA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 102079743 | Start Trial |
| European Patent Office | 1586571 | Start Trial |
| Cyprus | 1108393 | Start Trial |
| Japan | 2007314551 | Start Trial |
| Germany | 04029691 | Start Trial |
| Norway | 332232 | Start Trial |
| Peru | 20081734 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NESINA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1084705 | PA2014045 | Lithuania | Start Trial | PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919 |
| 1586571 | SPC/GB14/012 | United Kingdom | Start Trial | PRODUCT NAME: ALOGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/844/001-027 20130923 |
| 1586571 | 2014C/010 | Belgium | Start Trial | PRODUCT NAME: ALOGLIPTINE (EN TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/844/001 20130923 |
| 1084705 | C300709 | Netherlands | Start Trial | PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919 |
| 1586571 | PA2014011 | Lithuania | Start Trial | PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844 20130919 |
| 1586571 | 92374 | Luxembourg | Start Trial | PRODUCT NAME: ALOGLIPTIN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130923 |
| 1084705 | SPC/GB14/083 | United Kingdom | Start Trial | PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
