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Last Updated: July 2, 2022

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.

Recent Clinical Trials for pioglitazone hydrochloride

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

SponsorPhase
EMSPhase 3
Cairo UniversityPhase 4
St. Louis UniversityPhase 2

See all pioglitazone hydrochloride clinical trials

Generic filers with tentative approvals for PIOGLITAZONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing45MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing30MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing15MGTABLET; ORAL

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

Anatomical Therapeutic Chemical (ATC) Classes for pioglitazone hydrochloride

US Patents and Regulatory Information for pioglitazone hydrochloride

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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