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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 seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Alogliptin benzoate has sixty-seven patent family members in thirty-five countries.
There are ten drug master file entries for alogliptin benzoate. Two suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for alogliptin benzoate
International Patents: | 67 |
US Patents: | 7 |
Tradenames: | 3 |
Applicants: | 1 |
NDAs: | 3 |
Drug Master File Entries: | 10 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 60 |
Clinical Trials: | 6 |
Patent Applications: | 32 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for alogliptin benzoate |
DailyMed Link: | alogliptin benzoate at DailyMed |
Recent Clinical Trials for alogliptin benzoate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Yonsei University | Phase 4 |
Takeda | Phase 3 |
Takeda | Phase 4 |
Generic filers with tentative approvals for ALOGLIPTIN BENZOATE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 6.25MG | TABLET;ORAL |
Start Trial | Start Trial | EQ 25MG BASE | TABLET;ORAL |
Start Trial | Start Trial | EQ 12.5MG BASE | TABLET;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
Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Paragraph IV (Patent) Challenges for ALOGLIPTIN BENZOATE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
NESINA | TABLET;ORAL | alogliptin benzoate | 022271 | 2017-01-25 |
US Patents and Regulatory Information for alogliptin benzoate
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 | 022271-001 | 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 |
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 | 022271-002 | Jan 25, 2013 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for alogliptin benzoate
Country | Patent Number | Estimated Expiration |
---|---|---|
Spain | 2639854 | Start Trial |
Israel | 220480 | Start Trial |
South Korea | 101071389 | Start Trial |
Poland | 1586571 | Start Trial |
Taiwan | I344962 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for alogliptin benzoate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1586571 | PA2014011,C1586571 | Lithuania | Start Trial | PRODUCT NAME: ALOGLIPTINAS; REGISTRATION NO/DATE: EU/1/13/844 20130919 |
1586571 | 2014/012 | Ireland | Start Trial | PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919 |
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 |
1586571 | C 2014 011 | Romania | Start Trial | PRODUCT NAME: ALOGLIPTIN; NATIONAL AUTHORISATION NUMBER: EU/1/13/844/001 - EU/1/13/844/027; DATE OF NATIONAL AUTHORISATION: 20130919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/844/001 - EU/1/13/844/027; DATE OF FIRST AUTHORISATION IN EEA: 20130919 |
1084705 | C01084705/05 | Switzerland | Start Trial | PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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