Details for New Drug Application (NDA): 022426
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NDA 022426 describes OSENI, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the OSENI profile page.
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.
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 | 45802-238 | 45802-238-65 | 30 TABLET, FILM COATED in 1 BOTTLE (45802-238-65) |
| 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) |
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: | ⤷ Try a Trial | Patent Expiration: | Jun 27, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN | ||||||||
| Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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 | 022426-001 | Jan 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-002 | Jan 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-004 | Jan 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-004 | Jan 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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