ACTOS Drug Patent Profile

When do Actos patents expire, 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Actos

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

Summary for ACTOS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	140
Patent Applications:	3,756
Formulation / Manufacturing:	see details
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

See drug prices for ACTOS

See drug sales revenues 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

Anatomical Therapeutic Chemical (ATC) Classes for ACTOS

A10BG	Thiazolidinediones
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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

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
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-003	Jul 15, 1999
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-001	Jul 15, 1999

International Patents for ACTOS

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

Country	Patent Number	Title	Estimated Expiration
Norway	317341
Japan	H10167986	MEDICINE
Cyprus	2424	Pharmaceutical composition for use in treatment ofdiabetes.
Germany	122009000064
Germany	69637988
European Patent Office	2292268

Supplementary Protection Certificates for ACTOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0861666	91298	Luxembourg		91298, EXPIRES: 20210620
1174135	C01174135/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0861666	291	Finland
1174135	SPC026/2009	Ireland		SPC026/2009: 20101001, EXPIRES: 20210619
1174135	CA 2009 00045	Denmark
1174135	SPC/GB10/011	United Kingdom		PRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU