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Last Updated: March 19, 2024

Rosiglitazone maleate - Generic Drug Details


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What are the generic sources for rosiglitazone maleate and what is the scope of patent protection?

Rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Woodward and Ani Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for rosiglitazone maleate. There are six tentative approvals for this compound.

Summary for rosiglitazone maleate
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 11
Raw Ingredient (Bulk) Api Vendors: 75
Clinical Trials: 22
Patent Applications: 5,005
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in rosiglitazone maleate?rosiglitazone maleate excipients list
DailyMed Link:rosiglitazone maleate at DailyMed
Recent Clinical Trials for rosiglitazone maleate

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

SponsorPhase
Mutual Pharmaceutical Company, Inc.Phase 1
Cetero Research, San AntonioPhase 1
GlaxoSmithKlinePhase 1

See all rosiglitazone maleate clinical trials

Generic filers with tentative approvals for ROSIGLITAZONE MALEATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial2MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial8MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial4MGTABLET; 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 rosiglitazone maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Woodward AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Woodward AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms ROSIGLITAZONE MALEATE rosiglitazone maleate TABLET;ORAL 076747-002 Jan 25, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms ROSIGLITAZONE MALEATE rosiglitazone maleate TABLET;ORAL 076747-001 Jan 25, 2013 DISCN 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 rosiglitazone maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Woodward AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 ⤷  Try a Trial ⤷  Try a Trial
Woodward AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 ⤷  Try a Trial ⤷  Try a Trial
Woodward AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 ⤷  Try a Trial ⤷  Try a Trial
Woodward AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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