Details for New Drug Application (NDA): 022271
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NDA 022271 describes NESINA, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from five suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NESINA profile page.
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.
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.
Summary for 022271
| Tradename: | NESINA |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | alogliptin benzoate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022271
Generic Entry Date for 022271*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 022271
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 022271
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NESINA | alogliptin benzoate | TABLET;ORAL | 022271 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-087 | 45802-087-65 | 30 TABLET, FILM COATED in 1 BOTTLE (45802-087-65) |
| NESINA | alogliptin benzoate | TABLET;ORAL | 022271 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-103 | 45802-103-65 | 30 TABLET, FILM COATED in 1 BOTTLE (45802-103-65) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 6.25MG BASE | ||||
| Approval Date: | Jan 25, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 27, 2026 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jun 27, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Dec 2, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN | ||||||||
Expired US Patents for NDA 022271
| 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 | ⤷ Subscribe | ⤷ Subscribe |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-001 | Jan 25, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-002 | Jan 25, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-002 | Jan 25, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-001 | Jan 25, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271-003 | Jan 25, 2013 | ⤷ Subscribe | ⤷ Subscribe |
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