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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Moodys
QuintilesIMS
Medtronic
Colorcon
Dow
Chubb
Queensland Health
Citi

Generated: August 15, 2018

DrugPatentWatch Database Preview

PROMACTA Drug Profile

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When do Promacta patents expire, 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
Generic Entry Opportunity Date for PROMACTA
Generic Entry Dates for PROMACTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SUSPENSION;ORAL
Generic Entry Dates for PROMACTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX 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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Paragraph IV (Patent) Challenges for PROMACTA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 50 mg and 75 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 12.5 mg and 25 mg ➤ Subscribe ➤ Try a Free Trial

Non-Orange Book US Patents for PROMACTA

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
7,674,887 Thrombopoietin mimetics ➤ Try a Free Trial
8,088,813 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) ➤ Try a Free Trial
6,211,200 Metal complexes ➤ Try a Free Trial
8,846,024 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) ➤ Try a Free Trial
7,335,649 Thrombopoietin mimetics ➤ Try a Free Trial
6,413,952 Agonizing dimeric cell-surface receptors with a receptor binding moiety and chelating metal ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for PROMACTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0034 France ➤ Try a Free Trial PRODUCT NAME: ELTROMBOPAG EVENTUELLEMENT SOUS LA FORME D'UN SEL OU D'UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (INCLUANT UN HYDRATE; REGISTRATION NO/DATE: EU/1/10/612/001 20100311
2010 00017 Denmark ➤ Try a Free Trial
2010007 Lithuania ➤ Try a Free Trial 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
681 Luxembourg ➤ Try a Free Trial 91681, EXPIRES: 20250311
1294378/01 Switzerland ➤ Try a Free Trial FORMER OWNER: GLAXOSMITHKLINE LLC, US
/2010 Austria ➤ Try a Free Trial PRODUCT NAME: ELTROMBOPAG, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS UND SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
US Department of Justice
Cerilliant
Express Scripts
Medtronic
Cipla
Merck
McKinsey
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.