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Last Updated: November 22, 2024

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - Generic Drug Details


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

Metformin hydrochloride; rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Sb Pharmco and Teva, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Recent Clinical Trials for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

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

SponsorPhase
GlaxoSmithKlinePhase 1
Daiichi Sankyo Inc.Phase 3
Daiichi Sankyo, Inc.Phase 3

See all METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE clinical trials

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AVANDAMET Tablets metformin hydrochloride; rosiglitazone maleate 1 mg/ 500 mg, 2 mg/ 500mg 4 mg/ 500 mg 2 mg/ 1000 mg 4 mg/ 1000 mg 021410 1 2004-10-22

US Patents and Regulatory Information for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-002 Oct 10, 2002 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 077337-005 May 19, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 077337-004 May 7, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-005 Aug 25, 2003 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 077337-002 May 7, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-001 Oct 10, 2002 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 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

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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.