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Last Updated: November 4, 2024

AVANDARYL Drug Patent Profile


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Which patents cover Avandaryl, and what generic alternatives are available?

Avandaryl is a drug marketed by Sb Pharmco and is included in one NDA.

The generic ingredient in AVANDARYL is glimepiride; rosiglitazone maleate. There are sixteen drug master file entries for this compound. Additional details are available on the glimepiride; rosiglitazone maleate profile page.

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Summary for AVANDARYL
Drug patent expirations by year for AVANDARYL
Recent Clinical Trials for AVANDARYL

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SponsorPhase
GlaxoSmithKlinePhase 3

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Paragraph IV (Patent) Challenges for AVANDARYL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AVANDARYL Tablets glimepiride; rosiglitazone maleate 8 mg/2 mg 8 mg/4 mg 021700 1 2008-05-30
AVANDARYL Tablets glimepiride; rosiglitazone maleate 1 mg/4 mg 2 mg/4 mg 4 mg/4 mg 021700 1 2006-12-22

US Patents and Regulatory Information for AVANDARYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-001 Nov 23, 2005 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-003 Nov 23, 2005 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-002 Nov 23, 2005 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-004 Mar 30, 2007 DISCN Yes 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 AVANDARYL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-003 Nov 23, 2005 ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-002 Nov 23, 2005 ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-004 Mar 30, 2007 ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-003 Nov 23, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AVANDARYL

See the table below for patents covering AVANDARYL around the world.

Country Patent Number Title Estimated Expiration
Poland 307812 ⤷  Sign Up
Gulf Cooperation Council 0000250 5-Ä4-Ä2-(N-methyl-n-(2-pyridyl) amino) ethoxyÜ benzylÜthiazolidine-2,4-dione maleci acid salt ⤷  Sign Up
South Korea 0169463 ⤷  Sign Up
China 1063942 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AVANDARYL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0306228 SPC/GB01/002 United Kingdom ⤷  Sign Up 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 CA 2001 00001 Denmark ⤷  Sign Up
0658161 SPC/GB01/003 United Kingdom ⤷  Sign Up PRODUCT NAME: N-(4-(2(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY)BENZYL)THIAZOLIDINE-2,4-DIONE MALEIC ACID, "ROSIGLITAZONE MALEATE", ITS TAUTOMERS 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 C300035 Netherlands ⤷  Sign Up PRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT.
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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