DrugPatentWatch Database Preview
PROMACTA Drug Profile
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
International Patents: | 187 |
US Patents: | 14 |
Applicants: | 1 |
NDAs: | 2 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 76 |
Clinical Trials: | 26 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PROMACTA |
DailyMed Link: | PROMACTA at DailyMed |

Pharmacology 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 KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ 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 | |||
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 | 022291-002 | Nov 20, 2008 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | 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 |
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 |
International Patents for PROMACTA
Country | Document Number | Estimated Expiration |
---|---|---|
Japan | 2017137343 | ➤ Sign Up |
Malaysia | 136707 | ➤ Sign Up |
Denmark | 1864981 | ➤ Sign Up |
Luxembourg | 91681 | ➤ Sign Up |
China | 100423721 | ➤ Sign Up |
South Korea | 101090643 | ➤ Sign Up |
Spain | 2565179 | ➤ Sign Up |
Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for PROMACTA
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|
C020/2010 | Ireland | ➤ Sign Up | SPC020/2010: 20110308, EXPIRES: 20250310 |
681 | Luxembourg | ➤ Sign Up | 91681, EXPIRES: 20250311 |
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 |
1294378/01 | Switzerland | ➤ Sign Up | FORMER OWNER: GLAXOSMITHKLINE LLC, US |
2010 00017 | Denmark | ➤ Sign Up | |
C0034 | France | ➤ Sign Up | 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 |
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 |
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |