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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

ELTROMBOPAG OLAMINE - Generic Drug Details

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What are the generic drug sources for eltrombopag olamine and what is the scope of patent protection?

Eltrombopag olamine is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are twelve 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 seventy-eight patent family members in forty-two countries.

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

Summary for ELTROMBOPAG OLAMINE
International Patents:178
US Patents:12
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 56
Clinical Trials: 14
Patent Applications: 54
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in ELTROMBOPAG OLAMINE?ELTROMBOPAG OLAMINE excipients list
DailyMed Link:ELTROMBOPAG OLAMINE at DailyMed
Recent Clinical Trials for ELTROMBOPAG OLAMINE

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

SponsorPhase
Case Comprehensive Cancer CenterPhase 2
Novartis PharmaceuticalsPhase 2
M.D. Anderson Cancer CenterPhase 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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 022291-001 Nov 20, 2008 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 ⤷  Free Forever Trial ⤷  Free Forever 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 SPC020/2010 Ireland ⤷  Free Forever Trial SPC020/2010: 20110308, EXPIRES: 20250310
1534390 C20100006 Estonia ⤷  Free Forever Trial PRODUCT NAME: REVOLADE-ELTROMBOPAG; AUTHORISATIN NO.: EMA/CHMP/697489/2018; AUTHORISATION DATE: 20181019
1294378 388 Finland ⤷  Free Forever Trial
1534390 C 2010 013 Romania ⤷  Free Forever 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
1294378 91681 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: ELTROMBOPAG, EVENTUELLEMENT SOUS FORME D'UN SEL OU D'UN SOLVATE (Y COMPRIS SOUS FORME D'UN HYDRATE) PHARMACEUTIQUEMENT ACCEPTABLE (REVOLADE ); AUTHORISATION NUMBER AND DATE: EU/1/10/612/001-006 - REVOLADE-ELTROMBOPAG 20100315
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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