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Last Updated: November 22, 2024

ELTROMBOPAG OLAMINE - Generic Drug Details


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What are the generic sources for eltrombopag olamine and what is the scope of freedom to operate?

Eltrombopag olamine is the generic ingredient in three branded drugs marketed by Annora Pharma and Novartis, and is included in three NDAs. There are six 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 eight patent family members in forty countries.

There are three drug master file entries for eltrombopag olamine. One supplier is listed for this compound.

Summary for ELTROMBOPAG OLAMINE
Recent Clinical Trials for ELTROMBOPAG OLAMINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Taiwan University HospitalPhase 2
NovartisPhase 2
Cangzhou Central HospitalPhase 4

See all ELTROMBOPAG OLAMINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ELTROMBOPAG OLAMINE
Paragraph IV (Patent) Challenges for ELTROMBOPAG OLAMINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PROMACTA KIT For Oral Suspension eltrombopag olamine 12.5 mg/packet and 25 mg/packet 207027 1 2022-04-22
PROMACTA Tablets eltrombopag olamine 12.5 mg and 25 mg 022291 1 2014-02-04
PROMACTA Tablets eltrombopag olamine 50 mg and 75 mg 022291 1 2014-01-07

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 PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 AB 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

Expired US Patents for ELTROMBOPAG OLAMINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 ⤷  Sign Up ⤷  Sign Up
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 ⤷  Sign Up ⤷  Sign Up
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 ⤷  Sign Up ⤷  Sign Up
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 ⤷  Sign Up ⤷  Sign Up
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 ⤷  Sign Up ⤷  Sign Up
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 ⤷  Sign Up ⤷  Sign Up
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ELTROMBOPAG OLAMINE

Country Patent Number Title Estimated Expiration
Hong Kong 1136968 新穎的藥物組合物 (NOVEL PHARMACEUTICAL COMPOSITION) ⤷  Sign Up
Israel 238840 טבליות רוקחיות המכילות אלטרומבופאג אולמין, שיטות להכנתן ושימושן בהכנת תרופות לטיפול בתרומבוציטופניה (Pharmaceutical tablets containing eltrombopag olamine, methods for their preparation and use thereof in the preparation of medicaments for treating thrombocytopenia) ⤷  Sign Up
European Patent Office 2152237 NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION) ⤷  Sign Up
South Korea 101632851 ⤷  Sign Up
China 1652842 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 bis-(monoethanolamine) ⤷  Sign Up
Taiwan 201410240 Pharmaceutical tablets, solid oral pharmaceutical dosage forms, pharmaceutical capsules and pharmaceutical granules comprising 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carbox ⤷  Sign Up
Taiwan 200407128 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 bis-(monoethanolamine) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ELTROMBOPAG OLAMINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1294378 2010C/018 Belgium ⤷  Sign Up PRODUCT NAME: ELTROMBOPAG, OPTIONNELLEMENT SOUS FORME DE SEL OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS UN HYDRATE); AUTHORISATION NUMBER AND DATE: EU/1/10/612/001 20100315
1294378 SPC/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 20100315; UK EU1/10/612/002 20100315; UK EU1/10/612/003 20100315; UK EU1/10/612/004 20100315; UK EU1/10/612/005 20100315; UK EU1/10/612/006 20100315
1534390 C20100006 Estonia ⤷  Sign Up PRODUCT NAME: REVOLADE-ELTROMBOPAG; AUTHORISATIN NO.: EMA/CHMP/697489/2018; AUTHORISATION DATE: 20181019
1294378 300451 Netherlands ⤷  Sign Up PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT (MET INBEGRIP VAN EEN HYDRAAT), IN HET BIJZONDER ELTROMBOPAG OLAMINE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100315
1294378 23/2010 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-EU/1/10/612/006 (MITTEILUNG) 20100315
1294378 2010/020 Ireland ⤷  Sign Up PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE).; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
1534390 PA2010007 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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