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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Cipla
Dow
Teva
McKinsey
UBS
Cerilliant
Chinese Patent Office
Queensland Health

Generated: October 15, 2018

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Metformin hydrochloride; rosiglitazone maleate - Generic Drug Details

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What are the generic drug sources for metformin hydrochloride; rosiglitazone maleate and what is the scope of metformin hydrochloride; rosiglitazone maleate 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. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are forty-eight drug master file entries for metformin hydrochloride; rosiglitazone maleate.

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 021410-001 Oct 10, 2002 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ 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
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-002 Oct 10, 2002 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ 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
Teva ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 077337-003 May 7, 2014 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 077337-001 May 7, 2014 DISCN No 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

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Expired US Patents for metformin hydrochloride; rosiglitazone maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-001 Oct 10, 2002 ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-003 Oct 10, 2002 ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-003 Oct 10, 2002 ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-002 Oct 10, 2002 ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-003 Oct 10, 2002 ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-004 Aug 25, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for metformin hydrochloride; rosiglitazone maleate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00037 Denmark ➤ Sign Up PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
2008013 Lithuania ➤ Sign Up PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
2014026 Lithuania ➤ Sign Up PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2014 00037 Denmark ➤ Sign Up PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
2014000071 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
90013-0 Sweden ➤ Sign Up PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Cipla
Dow
Teva
McKinsey
UBS
Cerilliant
Chinese Patent Office
Queensland Health

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