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Generated: April 24, 2019

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Rosiglitazone maleate - Generic Drug Details

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What are the generic drug sources for rosiglitazone maleate and what is the scope of rosiglitazone maleate freedom to operate?

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. Additional information is available in the individual branded drug profile pages.

Rosiglitazone maleate has forty-five patent family members in thirty-six countries.

There are twelve drug master file entries for rosiglitazone maleate. One supplier is listed for this compound. There are six tentative approvals for this compound.

Summary for rosiglitazone maleate
Synonyms for rosiglitazone maleate
(+ -)-5-[[4-2-(methyl]-2-pyridinylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione,(Z)-2-butenedioate (1:1)
(+-)-5-(p-(2-(Methyl-2-pyridylamino)ethoxy)benzyl)-2,4-thiazolidinedione maleate (1:1)
(Z)-2-butenedioic acid; 5-[[4-[2-[methyl(2-pyridinyl)amino]ethoxy]phenyl]methyl]thiazolidine-2,4-dione
(Z)-but-2-enedioic acid; 5-[[4-[2-[methyl(pyridin-2-yl)amino]ethoxy]phenyl]methyl]-1,3-thiazolidine-2,4-dione
(Z)-but-2-enedioic acid;5-[[4-[2-[methyl(pyridin-2-yl)amino]ethoxy]phenyl]methyl]-1,3-thiazolidine-2,4-dione
141R290
155141-29-0
2, 5-[[4-[2-(methyl-2-pyridinylamino) ethoxy]phenyl]methyl]-, (2Z)-2-butenedioate (1:1)
2,4-Thiazolidinedione, 5-((4-(2-(methyl-2-pyridinylamino)ethoxy)phenyl)methyl)-, (2Z)-2-butenedioate (1:1)
2,4-Thiazolidinedione,5-((4-(2-(methyl-2-pyridinylamino)ethoxy)phenyl)methyl)-,(2Z)-2-butenedioate
5-(4-(2-(methyl(pyridin-2-yl)amino)ethoxy)benzyl)thiazolidine-2,4-dione maleate
5-[(4-{2-[methyl(pyridin-2-yl)amino]ethoxy}phenyl)methyl]-1,3-thiazolidine-2,4-dione; but-2-enedioic acid
5-[4-[2-(N-methyl-N-(2-pyridyl)amino)ethoxy]benzyl]thiazolidine-2,4-dione maleate
5-[4-[2-[N-methyl-N-(2-pyridyl)amino)ethoxy]benzyl]thiazolidine-2,4-dione maleate
5-[4-[2-[N-methyl-N-(2-pyridyl)amino]ethoxy]phenyl methyl]thiazolidine-2,4-dione maleate
5-{[4-({2-[methyl(pyridin-2-yl)amino]ethyl}oxy)phenyl]methyl}-1,3-thiazolidine-2,4-dione (2Z)-but-2-enedioate
5-{P-[2-(METHYL-2-PYRIDYLAMINO)ETHOXY]BENZYL}-2,4-THIAZOLIDINEDIONE MALEATE
A809615
AB0073096
AC-737
AC1NQXYB
AK326241
AKOS015961534
AN-15585
Avandamet
Avandia
Avandia (TN)
Avandia administration for 6-12 weeks
BC207045
BRL 49653-C
BRL 49653C
BRL-49653-C
BRL-49653C
C18H19N3O3S.C4H4O4
CAS-155141-29-0
CCG-100943
CCG-208126
CHEBI:8892
CHEMBL843
CPD000471612
CS-1692
D00596
DSSTox_CID_3569
DSSTox_GSID_23569
DSSTox_RID_77086
DTXSID2023569
HMS2051B11
HMS2233I10
HY-14600
K-4902
KS-5027
LS-173475
maleic acid; 5-[[4-[2-[methyl(2-pyridyl)amino]ethoxy]phenyl]methyl]thiazolidine-2,4-dione
maleic acid; rosiglitazone
MLS001306472
MLS001401426
MolPort-003-850-205
NC00193
NCGC00255233-01
NSC-717764
NSC717764
Nyracta
Rosiglitazone (maleate)
Rosiglitazone maleate (JAN/USAN)
Rosiglitazone Maleate [USAN]
Rosiglitazone XR
s2505
SAM001246610
SB-206846
SB-210232
SCHEMBL19023
SMR000471612
SUFUKZSWUHZXAV-BTJKTKAUSA-N
SW197573-4
Tox21_302367
Venvia
Z-8295
Tentative approvals for ROSIGLITAZONE MALEATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up8MGTABLET; ORAL
➤ Sign Up➤ Sign Up4MGTABLET; ORAL
➤ Sign Up➤ Sign Up2MGTABLET; ORAL

US Patents and Regulatory Information for 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 AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Teva ROSIGLITAZONE MALEATE rosiglitazone maleate TABLET;ORAL 076747-002 Jan 25, 2013 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Teva ROSIGLITAZONE MALEATE rosiglitazone maleate TABLET;ORAL 076747-001 Jan 25, 2013 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva ROSIGLITAZONE MALEATE rosiglitazone maleate TABLET;ORAL 076747-003 Jan 25, 2013 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 rosiglitazone maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999 ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999 ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for rosiglitazone maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0306228 38/2000 Austria ➤ Sign Up PRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
0658161 01C0002 France ➤ Sign Up PRODUCT NAME: MALEATE DE ROSIGLITAZONE OU L UN DE SES ISOMERES OU UNE DE SES FORMES TAUTOMERES ET/OU UN DE SES SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/00/137/001 DU 20000711; REGISTRATION NO/DATE AT EEC: IKS Nø 55 176 DU 19990929
0306228 SPC/GB01/002 United Kingdom ➤ Sign Up PRODUCT NAME: 5-(4-(2-(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY) BENZYL)-2,4-THIAZOLIDINEDIONE, "ROSIGLITAZONE" ITS TAUTOMERS, PHARMACEUTICALLY ACCEPTABLE SALTS, SUCH AS THE MALEATE, AND PHARMACEUTICALLY ACCEPTABLE SOLVATES.; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
0658161 SPC/GB01/003 United Kingdom ➤ Sign Up PRODUCT NAME: N-(4-(2(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY)BENZYL)THIAZOLIDINE-2,4-DIONE MALEIC ACID, "ROSIGLITAZONE MALEATE", ITS TAUTOMERS AND PHARMACEUTICALLY ACCEPTABLE SOLVATES; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK 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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