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Last Updated: August 7, 2020

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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, Aurobindo Pharma Ltd, Breckenridge, Celltrion, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Neopharma, Prinston Inc, Puracap Pharm Llc, Sandoz, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for pioglitazone hydrochloride. Twenty-four 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
Azienda Ospedaliero-Universitaria di ParmaPhase 2/Phase 3
National Center for Advancing Translational Science (NCATS)Phase 1/Phase 2
Milton S. Hershey Medical CenterPhase 1/Phase 2

See all PIOGLITAZONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for PIOGLITAZONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial45MGTABLET; ORAL
  Start Trial  Start Trial30MGTABLET; ORAL
  Start Trial  Start 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.

Paragraph IV (Patent) Challenges for PIOGLITAZONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ACTOS TABLET;ORAL pioglitazone hydrochloride 021073

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
Teva Pharms Usa PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 077210-002 Jan 10, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 204133-001 Apr 7, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Puracap Pharm Llc PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 206738-003 Oct 6, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Prinston Inc PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 207806-003 Apr 17, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET;ORAL 202467-002 Feb 6, 2013 AB RX No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-001 Jul 15, 1999   Start Trial   Start Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-003 Jul 15, 1999   Start Trial   Start Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-001 Jul 15, 1999   Start Trial   Start Trial
Takeda Pharms Usa ACTOS pioglitazone hydrochloride TABLET;ORAL 021073-002 Jul 15, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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