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Last Updated: March 28, 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 patent protection?

Pioglitazone hydrochloride is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa, Accord Hlthcare, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Macleods Pharms Ltd, Mylan Pharms Inc, Nostrum Labs Inc, 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-five 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
⤷  Try a Trial⤷  Try a Trial45MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial30MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial15MGTABLET; ORAL

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

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
Prinston Inc PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 207806-003 Apr 17, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nostrum Labs Inc PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 078472-002 Feb 13, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Prinston Inc PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 207806-001 Apr 17, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

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 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-002 Jul 15, 1999 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-003 Jul 15, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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