Details for New Drug Application (NDA): 022271
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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: | ⤷ Sign Up | Patent Expiration: | Jun 27, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN | ||||||||
Patent: | ⤷ Sign Up | 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 | ⤷ 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 |
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 |
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