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Generated: March 18, 2019

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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.

Metformin hydrochloride; rosiglitazone maleate has sixty-seven patent family members in forty-four countries.

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

Summary 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 021410-003 Oct 10, 2002 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-004 Aug 25, 2003 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Teva ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 077337-003 May 7, 2014 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-002 Oct 10, 2002 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Teva ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 077337-001 May 7, 2014 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 077337-004 May 7, 2014 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 077337-005 May 19, 2017 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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

International Patents for metformin hydrochloride; rosiglitazone maleate

Country Patent Number Estimated Expiration
Poland 355331 ➤ Try a Free Trial
Eurasian Patent Organization 004878 ➤ Try a Free Trial
Japan 4865975 ➤ Try a Free Trial
Montenegro P34008 ➤ Try a Free Trial
Hungary 0204122 ➤ Try a Free Trial
Australia 1404001 ➤ Try a Free Trial
Portugal 1231918 ➤ Try a Free Trial
Country Patent Number Estimated Expiration

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Supplementary Protection Certificates for metformin hydrochloride; rosiglitazone maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 C01261586/02 Switzerland ➤ Try a Free Trial PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
1412357 77 5006-2008 Slovakia ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
1730131 C01730131/02 Switzerland ➤ Try a Free Trial PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
0861666 07C0006 France ➤ Try a Free Trial PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
1506211 C300677 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1412357 C300357 Netherlands ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1506211 PA2014026,C1506211 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Mallinckrodt
Daiichi Sankyo
Chubb
Teva

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