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Healthtrust
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Generated: August 20, 2018

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Eltrombopag olamine - Generic Drug Details

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What are the generic sources for eltrombopag olamine and what is the scope of eltrombopag olamine patent protection?

Eltrombopag olamine is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in two NDAs. There are fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Eltrombopag olamine has one hundred and eighty-seven patent family members in forty countries.

There are three drug master file entries for eltrombopag olamine. Two suppliers are listed for this compound.

Summary for eltrombopag olamine
Synonyms for eltrombopag olamine
(1,1'-Biphenyl)-3-carboxylic acid, 3'-((2Z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene)hydrazino)-2'-hydroxy-
(1,1'-Biphenyl)-3-carboxylic acid, 3'-((2Z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene)hydrazino)-2'-hydroxy, compound with 2-Aminoethanol (1:2)
(E)-3'-(2-(2-(3,4-dimethylphenyl)-5-methyl-3-oxo-2,3-dihydro-1H-pyrazol-4-yl)hydrazono)-2'-oxo-2',3'-dihydro-[1,1'-biphenyl]-3-carboxylic acid
(E)-3\'-(2-(1-(3,4-Dimethylphenyl)-3-methyl-5-oxo-1H-pyrazol-4(5H)-ylidene)hydrazinyl)-2\'-hydroxybiphenyl-3-carboxylic acid
(Z)-3'-(2-(1-(3,4-Dimethylphenyl)-3-methyl-5-oxo-1H-pyrazol-4(5H)-ylidene)hydrazinyl)-2'-hydroxy-[1,
(Z)-3'-(2-(1-(3,4-Dimethylphenyl)-3-methyl-5-oxo-1H-pyrazol-4(5H)-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid
[1,1'-Biphenyl]-3-carboxylic acid, 3'-[(2Z)-[1-(3,4-dime
1807882-48-9
2-aminoethan-1-ol hemi((E)-3'-(2-(2-(3,4-dimethylphenyl)-5-methyl-3-oxo-2,3-dihydro-1H-pyrazol-4-yl)hydrazono)-2'-oxo-2',3'-dihydro-[1,1'-biphenyl]-3-carboxylate)
2-aminoethanol with (Z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1H-pyrazol-4(5H)-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylate (2:1)
3-[(5E)-5-[[2-(3,4-dimethylphenyl)-5-methyl-3-oxo-1H-pyrazol-4-yl]hydrazono]-6-oxo-cyclohexa-1,3-dien-1-yl]benzoic acid
3'-((2Z)-2-(1-(3,4-Dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene)diazanyl)-2'-hydroxybiphenyl-3-carboxylic acid compound with 2-aminoethanol (1:2)
3'-[2-[(2Z)-1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazinyl]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid
3'-{(2z)-2-(1-[3,4-dimethylphenyl]-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)diazanyl}-2'-hydroxybiphenyl-3-carboxylic acid
3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxybiphenyl-3-carboxylic acid
3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazinyl}-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid
3'-{N'-[1-(3,4-dimethyl-phenyl)-3-methyl-5-oxo-1,5-dihydropyrazol-4-ylidene]hydrazino}-2'-hydroxybiphenyl-3-carboxylic acid
3608AH
443130-00-5
496775-61-2
496775-62-3
4CA-0492
4U07F515LG
775E612
A25156
AB01274808_02
AB01274808-01
AB1008446
ABP000381
AC-26286
AK-72820
AK174001
AKOS015920246
AKOS025396658
AKOS030524935
AN-589
BC678699
BCP9000641
BCPP000243
BR-72820
C25H22N4O4.2C2H7NO
CHEBI:85010
CHEMBL3186485
CHEMBL461806
CS-1565
CS-1566
D00PEH
D03978
DB06210
Eltrombopag
Eltrombopag (Olamine)
Eltrombopag [INN]
EltroMbopag diethanolaMine salt
Eltrombopag olamine (JAN/USAN)
Eltrombopag olamine [USAN:JAN]
Eltrombopag/
EN002876
EX-7216
EX-A443
HSDB 8212
HY-15306
HY-15306A
MFCD21090400
MFCD22380664
MolPort-006-170-138
MolPort-006-393-918
MolPort-009-679-439
MolPort-028-745-010
MolPort-042-652-614
ppromacta
Promacta
Promacta (TN)
PubChem20546
Revolade
s4502
S56D65XJ9G
SB 497115
SB 497115GR
SB-497115
SB-497115-GR
SB497115
SC-27871
SCHEMBL16207741
SCHEMBL164270
SCHEMBL210183
SCHEMBL211081
SCHEMBL211082
SCHEMBL2236368
SCHEMBL2236372
ST2402915
Thylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-(9CI)
UNII-4U07F515LG
UNII-S56D65XJ9G
X5021
ZINC100794657

US Patents and Regulatory Information for eltrombopag olamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 RX 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

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Non-Orange Book US Patents for eltrombopag olamine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,335,649 Thrombopoietin mimetics ➤ Sign Up
7,439,342 Thrombopoietin mimetics ➤ Sign Up
7,648,971 Thrombopoietin mimetics ➤ Sign Up
7,674,887 Thrombopoietin mimetics ➤ Sign Up
6,211,200 Metal complexes ➤ Sign Up
6,413,952 Agonizing dimeric cell-surface receptors with a receptor binding moiety and chelating metal ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for eltrombopag olamine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010007 Lithuania ➤ Sign Up PRODUCT NAME: ELTROMBOPAGUM OLAMINUM; REGISTRATION NO/DATE: EU/1/10/612/001, 2010 03 11 EU/1/10/612/002, 2010 03 11 EU/1/10/612/003, 2010 03 11 EU/1/10/612/004, 2010 03 11 EU/1/10/612/005, 2010 03 11 EU/1/10/612/006 20100311
/2010 Austria ➤ Sign Up PRODUCT NAME: ELTROMBOPAG, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS UND SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
8 Finland ➤ Sign Up
3-2010 Slovakia ➤ Sign Up PRODUCT NAME: ELTROMBOPAG; FIRST REGISTRATION NO/DATE: EU/1/10/612/001, EU/1/10/612/002, EU/1/10/612/003, EU/1/10/612/004, EU/1/10/612/005, EU/1/10/612/006; 20100311
2010007,C1534390 Lithuania ➤ Sign Up PRODUCT NAME: ELTROMBOPAGUM OLAMINUM; REGISTRATION NO/DATE: EU/1/10/612/001, 2010-03-11 EU/1/10/612/002, 2010-03-11 EU/1/10/612/003, 2010-03-11 EU/1/10/612/004, 2010-03-11 EU/1/10/612/005, 2010-03-11 EU/1/10/612/006 20100311
2010 00017 Denmark ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Merck
Teva
Cipla
Colorcon
Federal Trade Commission
Fish and Richardson
Cantor Fitzgerald
Harvard Business School

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