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Chinese Patent Office
Medtronic
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Mallinckrodt
US Department of Justice
McKesson
Johnson and Johnson
Federal Trade Commission
Julphar

Generated: May 24, 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.
Summary for PROMACTA
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 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 022291-001 Nov 20, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes ➤ 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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Paragraph IV (Patent) Challenges for PROMACTA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 50 mg and 75 mg ➤ Subscribe 2014-01-07
➤ Subscribe Tablets 12.5 mg and 25 mg ➤ Subscribe 2014-02-04

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
7,335,649 Thrombopoietin mimetics ➤ Sign Up
6,211,200 Metal complexes ➤ Sign Up
7,674,887 Thrombopoietin mimetics ➤ Sign Up
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) ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for PROMACTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
8 Finland ➤ Sign Up
C/GB10/026 United Kingdom ➤ Sign Up PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE); REGISTERED: UK EU1/10/612/001 20100311; UK EU1/10/612/002 20100311; UK EU1/10/612/003 20100311; UK EU1/10/612/004 20100311; UK EU1/10/612/005 20100311; UK EU1/10/612/006 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
2010000037 Germany ➤ Sign Up PRODUCT NAME: ELTROMBOPAG SOWIE PHARMAZEUTISCH ANNEHMBARE SALZE, HYDRATE UND SOLVATE DAVON; NAT. REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311; FIRST REGISTRATION: EU EU/1/10/612/001-/006 20100311
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Dow
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