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Last Updated: August 14, 2020

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ACTOS Drug Profile

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Which patents cover Actos, and when can generic versions of Actos launch?

Actos is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in ACTOS is pioglitazone hydrochloride. There are twenty-seven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pioglitazone hydrochloride profile page.

Paragraph IV (Patent) Challenges for ACTOS
Tradename Dosage Ingredient NDA Submissiondate
ACTOS TABLET;ORAL pioglitazone hydrochloride 021073

US Patents and Regulatory Information for ACTOS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-001 Jul 15, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-002 Jul 15, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-003 Jul 15, 1999 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ACTOS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-003 Jul 15, 1999   Start Trial   Start Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-001 Jul 15, 1999   Start Trial   Start Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-003 Jul 15, 1999   Start Trial   Start Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-003 Jul 15, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ACTOS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0193256 C300038 Netherlands   Start Trial PRODUCT NAME: PIOGLITAZON, DESGEWENST IN DE VORM VAN EEN FARMACOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/00/151/001 - EU/1/00/151/006 20001011
0861666 CA 2007 00001 Denmark   Start Trial
0861666 300258 Netherlands   Start Trial 300258, 20160620, EXPIRES: 20210619
1174135 437 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Medtronic
Merck
Harvard Business School
Colorcon

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