Details for New Drug Application (NDA): 022426
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The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride profile page.
Summary for 022426
Tradename: | OSENI |
Applicant: | Takeda Pharms Usa |
Ingredient: | alogliptin benzoate; pioglitazone hydrochloride |
Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022426
Generic Entry Date for 022426*:
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: 022426
Suppliers and Packaging for NDA: 022426
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-260 | 45802-260-65 | 30 TABLET, FILM COATED in 1 BOTTLE (45802-260-65) |
OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-351 | 45802-351-65 | 30 TABLET, FILM COATED in 1 BOTTLE (45802-351-65) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE;EQ 15MG BASE | ||||
Approval Date: | Jan 25, 2013 | TE: | RLD: | Yes | |||||
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 | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 15, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 022426
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-006 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-001 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-001 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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