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Last Updated: November 2, 2024

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, Chartwell Rx, Corepharma, Macleods Pharms Ltd, Mylan Pharms Inc, 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-seven 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
University of MinnesotaPhase 2
Wuhan Union Hospital, ChinaPhase 2
University of Campinas, BrazilPhase 4

See all pioglitazone hydrochloride clinical trials

Generic filers with tentative approvals for PIOGLITAZONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up45MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up30MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up15MGTABLET; 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
Chartwell Rx PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 078383-001 Mar 12, 2013 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 078383-002 Mar 12, 2013 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Prinston Inc PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 207806-003 Apr 17, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 078670-001 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

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 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-001 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 021073-003 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.