alogliptin Oral Tablet
- Brand(s)
- Nesina
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Takeda Pharmaceuticals America, Inc. (2015-08-31)
- Oldest Current Product
- 2013-01-25
- License(s)
- NDA
- RxNORM
- ORAL TABLET\ALOGLIPTIN
- FDAOB
- ORAL\TABLET\ALOGLIPTIN BENZOATE
- SPL Active
- ORAL\TABLET, FILM COATED\ALOGLIPTIN BENZOATE
- SPL Moiety
- ORAL\TABLET, FILM COATED\ALOGLIPTIN
product(s) by strength(s)
alogliptin 12.5 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 647640125 | Nesina | NDA | Takeda Pharmaceuticals America, Inc. | 2013-01-25 | ALOGLIPTIN BENZOATE | ORAL | TABLET, FILM COATED | NDA022271 | a3768c7e-aa4c-44d3-bc53-43bb7346c0b0 |
alogliptin 25 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 647640250 | Nesina | NDA | Takeda Pharmaceuticals America, Inc. | 2013-01-25 | ALOGLIPTIN BENZOATE | ORAL | TABLET, FILM COATED | NDA022271 | a3768c7e-aa4c-44d3-bc53-43bb7346c0b0 |
alogliptin 6.25 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 647640625 | Nesina | NDA | Takeda Pharmaceuticals America, Inc. | 2013-01-25 | ALOGLIPTIN BENZOATE | ORAL | TABLET, FILM COATED | NDA022271 | a3768c7e-aa4c-44d3-bc53-43bb7346c0b0 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA022271 | NESINA | TAKEDA PHARMACEUTICALS USA INC | 2013-01-25 | p6211205, METHODS OF REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER p6303640, METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER p8697125, SUBSTANCE p6890898, METHODS OF MODIFYING GLUCOSE METABOLISM AND TREATING DIABETES COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR AND ONE OR MORE OTHER THERAPEUTIC AGENTS SUCH AS METFORMIN p6303661, METHODS OF LOWERING ELEVATED POST PRANDIAL BLOOD GLUCOSE LEVELS COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR p6150383, METHODS OF TREATING LIPID METABOLISM AND GLYCOMETABOLISM DISORDERS COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER p7078381, METHODS OF MODIFYING GLUCOSE METABOLISM AND TREATING DIABETES COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR AND ONE OR MORE OTHER THERAPEUTIC AGENTS SUCH AS METFORMIN p7459428, METHODS OF TREATING DIABETES COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR AND METFORMIN p7807689, METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN, SUBSTANCE p8173663, METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN p6329404, METHODS OF TREATING DIABETES COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER, SUBSTANCE p8288539 | NEW CHEMICAL ENTITY [2018-01-25] | NDA022271_001, NDA022271_002, NDA022271_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA022271_001 | RX | ALOGLIPTIN BENZOATE (EQ 6.25MG BASE) | ORAL | TABLET | False | 2013-01-25 | NESINA |
| 2 | NDA022271_002 | RX | ALOGLIPTIN BENZOATE (EQ 12.5MG BASE) | ORAL | TABLET | False | 2013-01-25 | NESINA |
| 3 | NDA022271_003 | RX | ALOGLIPTIN BENZOATE (EQ 25MG BASE) | ORAL | TABLET | True | 2013-01-25 | NESINA |
patent(s)
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | a3768c7e-aa4c-44d3-bc53-43bb7346c0b0 (view SPL) | These highlights do not include all the information needed to use NESINA safely and effectively. See full prescribing information for NESINA. NESINA (alogliptin) tabletsInitial U.S. Approval: 2013 | prescription | Human Prescription | Takeda Pharmaceuticals America, Inc. | 2015-08-31 | 6 | 647640125, 647640250, 647640625 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII