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Last Updated: December 11, 2019

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ELTROMBOPAG OLAMINE - Generic Drug Details

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

Eltrombopag olamine is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are thirteen 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 ninety-six patent family members in forty-one 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
Case Comprehensive Cancer CenterPhase 2
Albert Einstein College of Medicine of Yeshiva UniversityPhase 2
National Cancer Institute (NCI)Phase 2

See all ELTROMBOPAG OLAMINE clinical trials

Paragraph IV (Patent) Challenges for ELTROMBOPAG OLAMINE
Tradename Dosage Ingredient NDA Submissiondate
PROMACTA TABLET;ORAL eltrombopag olamine 022291 2014-02-04
PROMACTA TABLET;ORAL eltrombopag olamine 022291 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   Start Trial   Start Trial Y   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No   Start Trial   Start Trial   Start Trial
>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 022291-005 Nov 16, 2012   Start Trial   Start Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ELTROMBOPAG OLAMINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1294378 300451 Netherlands   Start Trial 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 C300451 Netherlands   Start Trial PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
1534390 PA2010007 Lithuania   Start 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
1294378 23/2010 Austria   Start 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
1294378 2010C/018 Belgium   Start Trial 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 C01294378/01 Switzerland   Start Trial FORMER OWNER: GLAXOSMITHKLINE LLC, US
1534390 C 2010 013 Romania   Start Trial PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/612/001, RO EU/1/10/612/002, RO EU/1/10/612/003, RO EU/1/10/612/004, RO EU/1/10/612/005, RO EU/1/10/612/006; DATE OF NATIONAL AUTHORISATION: 20100311; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/612/001, EMEA EU/1/10/612/002, EMEA EU/1/10/612/003, EMEA EU/1/10/612/004, EMEA EU/1/10/612/005, EMEA EU/1/10/612/006; DATE OF FIRST AUTHORISATION IN EEA: 20100311
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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