ACTOS Drug Patent 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-seven suppliers are listed for this compound. Additional details are available on the pioglitazone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Actos

A generic version of ACTOS was approved as pioglitazone hydrochloride by CHARTWELL RX on October 26^th, 2012.

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Summary for ACTOS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	145
Patent Applications:	3,940
Drug Prices:	Drug price information for ACTOS
Drug Sales Revenues:	Drug sales revenues for ACTOS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACTOS
What excipients (inactive ingredients) are in ACTOS?	ACTOS excipients list
DailyMed Link:	ACTOS at DailyMed

Drug patent expirations by year for ACTOS

Pharmacology for ACTOS

Drug Class	Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist Thiazolidinedione
Mechanism of Action	Peroxisome Proliferator-activated Receptor Activity

US Patents and Regulatory Information for ACTOS

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-003	Jul 15, 1999	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

International Patents for ACTOS

See the table below for patents covering ACTOS around the world.

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Country	Patent Number	Title	Estimated Expiration
Norway	20004345		⤷ Sign Up
Czech Republic	9601811		⤷ Sign Up
Russian Federation	2327455	СПОСОБЫ ПРОФИЛАКТИКИ И ЛЕЧЕНИЯ, ПРИМЕНЕНИЕ УСИЛИТЕЛЕЙ ЧУВСТВИТЕЛЬНОСТИ К ИНСУЛИНУ (METHOD OF PREVENTION AND TREATMENT AND RELATED COMPLICATION)	⤷ Sign Up
Australia	5246786		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ACTOS

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0193256	SPC/GB01/016	United Kingdom	⤷ Sign Up	PRODUCT NAME: PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE HYDROCHLORIDE SALT; REGISTERED: CH IKS 55 378 01 20000927; CH IKS 55 378 02 20000927; CH IKS 55 378 03 20000927; UK EU/1/00/151/001 20001011; UK EU/1/00/151/002 20001011; UK EU/1/00/151/003 20001011; UK EU/1/00/151/004 20001011; UK EU/1/00/151/005 20001011; UK EU/1/00/151/006 20001011
0193256	2001C/011	Belgium	⤷ Sign Up	PRODUCT NUMBER: PIOGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/001/150/001 20001018; FIRST REGISTRATION NO: CH 55378 01 20000927
1174135	91606	Luxembourg	⤷ Sign Up	91606, EXPIRES: 20210620
1174135	SPC026/2009	Ireland	⤷ Sign Up	SPC026/2009: 20101001, EXPIRES: 20210619
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for ACTOS

Pharmacology for ACTOS

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