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Federal Trade Commission
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Generated: December 11, 2018

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AVANDAMET Drug Profile

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When do Avandamet patents expire, and what generic alternatives are available?

Avandamet is a drug marketed by Sb Pharmco and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixty-seven patent family members in forty-four countries.

The generic ingredient in AVANDAMET is metformin hydrochloride; rosiglitazone maleate. There are forty-eight drug master file entries for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.

US Patents and Regulatory Information for AVANDAMET

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 021410-004 Aug 25, 2003 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 021410-002 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 021410-005 Aug 25, 2003 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 021410-001 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 021410-003 Oct 10, 2002 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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 AVANDAMET

Paragraph IV (Patent) Challenges for AVANDAMET
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 1 mg/ 500 mg, 2 mg/ 500mg, 4 mg/ 500 mg, 2 mg/ 1000 mg and 4 mg/ 1000 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for AVANDAMET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00524 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
1730131/02 Switzerland ➤ Try a Free Trial PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
496 Luxembourg ➤ Try a Free Trial PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
/2008 Austria ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
C0006 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
0677 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Cantor Fitzgerald
Merck
Fuji
Federal Trade Commission
AstraZeneca
Chinese Patent Office
Cerilliant
Cipla

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