Details for New Drug Application (NDA): 203414
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The generic ingredient in KAZANO is alogliptin benzoate; metformin hydrochloride. 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; metformin hydrochloride profile page.
Summary for 203414
Tradename: | KAZANO |
Applicant: | Takeda Pharms Usa |
Ingredient: | alogliptin benzoate; metformin hydrochloride |
Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203414
Generic Entry Date for 203414*:
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: 203414
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 203414
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-169 | 45802-169-72 | 60 TABLET, FILM COATED in 1 BOTTLE (45802-169-72) |
KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-211 | 45802-211-72 | 60 TABLET, FILM COATED in 1 BOTTLE (45802-211-72) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 12.5MG BASE;500MG | ||||
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: | Mar 15, 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 203414
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
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