Details for New Drug Application (NDA): 203414
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NDA 203414 describes KAZANO, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the KAZANO profile page.
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.
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: | ⤷ 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: | 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 | ⤷ Subscribe | ⤷ Subscribe |
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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