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Last Updated: February 24, 2021

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Rosiglitazone maleate - Generic Drug Details

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

Rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Sb Pharmco and Ani Pharms Inc, and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Rosiglitazone maleate has forty-five patent family members in thirty-six countries.

There are twelve drug master file entries for rosiglitazone maleate. One supplier is listed for this compound. There are six tentative approvals for this compound.

Summary for rosiglitazone maleate
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
  Start Trial  Start Trial8MGTABLET; ORAL
  Start Trial  Start Trial4MGTABLET; ORAL
  Start Trial  Start Trial2MGTABLET; 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 ROSIGLITAZONE MALEATE
Tradename Dosage Ingredient NDA Submissiondate
AVANDIA TABLET;ORAL rosiglitazone maleate 021071

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
Ani Pharms Inc ROSIGLITAZONE MALEATE rosiglitazone maleate TABLET;ORAL 076747-003 Jan 25, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 RX Yes No   Start Trial   Start Trial Y   Start Trial
Ani Pharms Inc ROSIGLITAZONE MALEATE rosiglitazone maleate TABLET;ORAL 076747-002 Jan 25, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc ROSIGLITAZONE MALEATE rosiglitazone maleate TABLET;ORAL 076747-001 Jan 25, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999 DISCN Yes No   Start Trial   Start Trial Y   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 rosiglitazone maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999   Start Trial   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999   Start Trial   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999   Start Trial   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999   Start Trial   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999   Start Trial   Start Trial
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for rosiglitazone maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0306228 2001C/004 Belgium   Start Trial PRODUCT NAME: ROSIGLITAZONE; REGISTRATION NO/DATE: EU/1/00/137/001 20000717
0658161 C300035 Netherlands   Start Trial PRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT.
0306228 38/2000 Austria   Start Trial PRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
0306228 C300034 Netherlands   Start Trial PRODUCT NAME: ROSIGLITAZONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT, IN HET BIJZONDER ROSIGLITAZONE MALEAAT; REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711
0306228 SPC/GB01/002 United Kingdom   Start Trial PRODUCT NAME: 5-(4-(2-(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY) BENZYL)-2,4-THIAZOLIDINEDIONE, "ROSIGLITAZONE" ITS TAUTOMERS, PHARMACEUTICALLY ACCEPTABLE SALTS, SUCH AS THE MALEATE, AND PHARMACEUTICALLY ACCEPTABLE SOLVATES.; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
0658161 39/2000 Austria   Start Trial PRODUCT NAME: ROSIGLITAZONE MALEAT; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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