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Last Updated: November 24, 2024

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.
Summary for 022426
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.

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:RXDosage:TABLET;ORALStrengthEQ 25MG BASE;EQ 15MG BASE
Approval Date:Jan 25, 2013TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jun 27, 2028Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
Patent:⤷  Sign UpPatent Expiration:Mar 15, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
Patent:⤷  Sign UpPatent Expiration:Mar 15, 2025Product Flag?Substance Flag?YDelist 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.