Pioglitazone hydrochloride - Generic Drug Details

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What are the generic drug sources for pioglitazone hydrochloride and what is the scope of freedom to operate?

Pioglitazone hydrochloride is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa, Accord Hlthcare, Aurobindo Pharma Ltd, Celltrion, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Neopharma, Nostrum Labs Inc, Prinston Inc, Puracap Pharm Llc, Sandoz, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for pioglitazone hydrochloride. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for pioglitazone hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	15
Drug Master File Entries:	27
Suppliers / Packagers:	24
Bulk Api Vendors:	129
Clinical Trials:	443
Patent Applications:	3,985
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pioglitazone hydrochloride
What excipients (inactive ingredients) are in pioglitazone hydrochloride?	pioglitazone hydrochloride excipients list
DailyMed Link:	pioglitazone hydrochloride at DailyMed

Recent Clinical Trials for pioglitazone hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Humanitas Hospital, Italy	Phase 2
Mario Negri Institute for Pharmacological Research	Phase 2
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano	Phase 2

See all pioglitazone hydrochloride clinical trials

Generic filers with tentative approvals for PIOGLITAZONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	45MG	TABLET; ORAL
Start Trial	Start Trial	30MG	TABLET; ORAL
Start Trial	Start Trial	15MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pioglitazone hydrochloride

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

Paragraph IV (Patent) Challenges for PIOGLITAZONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
ACTOS	TABLET;ORAL	pioglitazone hydrochloride	021073

US Patents and Regulatory Information for pioglitazone hydrochloride

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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
Macleods Pharms Ltd	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	202467-001	Feb 6, 2013	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Neopharma	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	078383-002	Mar 12, 2013		DISCN	No	No	Start Trial	Start Trial				Start Trial
Torrent Pharms Ltd	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	091298-003	Feb 13, 2013		DISCN	No	No	Start Trial	Start Trial				Start Trial
Sandoz	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	078670-001	Feb 13, 2013	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Celltrion	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	076798-003	Oct 26, 2012	AB	RX	No	No	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 pioglitazone hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-001	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	021073-001	Jul 15, 1999	Start Trial	Start Trial
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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