PIOGLITAZONE HYDROCHLORIDE - Generic Drug Details

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What are the generic 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, Chartwell Rx, Corepharma, Macleods Pharms Ltd, Norvium Bioscience, Nostrum Labs Inc, Prinston Inc, Puracap Pharm Llc, Sandoz, 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-eight 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:	16
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	500
Patent Applications:	4,464
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
University of Minnesota	Phase 2
Wuhan Union Hospital, China	Phase 2
University of Campinas, Brazil	Phase 4

See all PIOGLITAZONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for PIOGLITAZONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	45MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	30MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	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 Peroxisome Proliferator-activated Receptor alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists

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
Aurobindo Pharma Ltd	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	200268-002	Feb 13, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms Usa Inc	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	202456-001	Feb 13, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	078670-002	Feb 13, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms Usa Inc	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	202456-002	Feb 13, 2013	AB	RX	No	No	⤷ 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 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	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	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	021073-001	Jul 15, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.