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Generated: December 10, 2018

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PROMACTA Drug Profile

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Which patents cover Promacta, and what generic alternatives are available?

Promacta is a drug marketed by Novartis Pharms Corp and is included in two NDAs. There are fourteen patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eighty-seven patent family members in forty countries.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.

Drug patent expirations by year for PROMACTA
Synonyms for PROMACTA
(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
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 (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 PROMACTA

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 022291-003 Sep 8, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 022291-001 Nov 20, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ 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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Paragraph IV (Patent) Challenges for PROMACTA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 12.5 mg and 25 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 50 mg and 75 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for PROMACTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
8 Finland ➤ Sign Up
1294378/01 Switzerland ➤ Sign Up FORMER OWNER: GLAXOSMITHKLINE LLC, US
C020/2010 Ireland ➤ Sign Up SPC020/2010: 20110308, EXPIRES: 20250310
681 Luxembourg ➤ Sign Up 91681, EXPIRES: 20250311
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Daiichi Sankyo
McKesson
Cipla
Fish and Richardson
AstraZeneca
US Department of Justice
UBS
Chubb

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