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, Annora Pharma, Aurobindo Pharma Ltd, Celltrion, Macleods Pharms Ltd, Mylan Pharms Inc, Nostrum Labs Inc, Picket Pharms, Prinston Inc, Puracap Pharm Llc, Sandoz, Shuangcheng, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for pioglitazone hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	16
NDAs:	16
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	480
Patent Applications:	4,388
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
EMS	Phase 3
Cairo University	Phase 4
St. Louis University	Phase 2

See all pioglitazone hydrochloride clinical trials

Generic filers with tentative approvals for PIOGLITAZONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
See Plans and Pricing	See Plans and Pricing	45MG	TABLET; ORAL
See Plans and Pricing	See Plans and Pricing	30MG	TABLET; ORAL
See Plans and Pricing	See Plans and Pricing	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	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 pioglitazone hydrochloride

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 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
Celltrion	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	076798-003	Oct 26, 2012	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Teva Pharms Usa	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	077210-003	Jan 10, 2014	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Puracap Pharm Llc	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	206738-001	Oct 6, 2017	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Puracap Pharm Llc	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	206738-002	Oct 6, 2017	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Zydus Pharms Usa Inc	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	202456-002	Feb 13, 2013	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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	021073-002	Jul 15, 1999	See Plans and Pricing	See Plans and Pricing
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999	See Plans and Pricing	See Plans and Pricing
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999	See Plans and Pricing	See Plans and Pricing
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-001	Jul 15, 1999	See Plans and Pricing	See Plans and Pricing
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-001	Jul 15, 1999	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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