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Last Updated: February 25, 2021

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AVANDARYL Drug 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. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has forty-five patent family members in thirty-six countries.

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.

US ANDA Litigation and Generic Entry Outlook for Avandaryl

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for AVANDARYL
International Patents:45
US Patents:1
Applicants:1
NDAs:1
Bulk Api Vendors: 113
Clinical Trials: 1
Formulation / Manufacturing:see details
DailyMed Link:AVANDARYL at DailyMed
Drug patent expirations by year for AVANDARYL
Recent Clinical Trials for AVANDARYL

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

SponsorPhase
GlaxoSmithKlinePhase 3

See all AVANDARYL clinical trials

Paragraph IV (Patent) Challenges for AVANDARYL
Tradename Dosage Ingredient NDA Submissiondate
AVANDARYL TABLET;ORAL glimepiride; rosiglitazone maleate 021700 2008-05-30
AVANDARYL TABLET;ORAL glimepiride; rosiglitazone maleate 021700 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   Start Trial   Start Trial Y   Start Trial
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-003 Nov 23, 2005 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-002 Nov 23, 2005 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-004 Mar 30, 2007 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 AVANDARYL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-001 Nov 23, 2005   Start Trial   Start Trial
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-002 Nov 23, 2005   Start Trial   Start Trial
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-003 Nov 23, 2005   Start Trial   Start Trial
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-005 Mar 30, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for AVANDARYL

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 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
0658161 01C0002 France   Start Trial PRODUCT NAME: MALEATE DE ROSIGLITAZONE OU L UN DE SES ISOMERES OU UNE DE SES FORMES TAUTOMERES ET/OU UN DE SES SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/00/137/001 DU 20000711; REGISTRATION NO/DATE AT EEC: IKS Nø 55 176 DU 19990929
0658161 C300035 Netherlands   Start Trial 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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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
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Johnson and Johnson
Boehringer Ingelheim

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