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Last Updated: November 22, 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
>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 021700-005 Mar 30, 2007 ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-005 Mar 30, 2007 ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDARYL glimepiride; rosiglitazone maleate TABLET;ORAL 021700-001 Nov 23, 2005 ⤷  Sign Up ⤷  Sign Up
>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
0658161 C300035 Netherlands ⤷  Sign Up PRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT.
0306228 C300034 Netherlands ⤷  Sign Up 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
0658161 39/2000 Austria ⤷  Sign Up 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.