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Last Updated: September 23, 2021

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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 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: 12
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
Albert Einstein College of Medicine of Yeshiva UniversityPhase 2
National Cancer Institute (NCI)Phase 2

See all eltrombopag olamine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for eltrombopag olamine
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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 022291-004 Oct 20, 2011 ⤷  Try it Free ⤷  Try it Free
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 ⤷  Try it Free ⤷  Try it Free
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 ⤷  Try it Free ⤷  Try it Free
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 ⤷  Try it Free ⤷  Try it Free
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 ⤷  Try it Free ⤷  Try it Free
>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
1534390 C20100006 Estonia ⤷  Try it Free PRODUCT NAME: REVOLADE-ELTROMBOPAG; AUTHORISATIN NO.: EMA/CHMP/697489/2018; AUTHORISATION DATE: 20181019
1294378 CA 2010 00017 Denmark ⤷  Try it Free
1294378 300451 Netherlands ⤷  Try it Free 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 10C0034 France ⤷  Try it Free 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 20100315
1294378 SPC/GB10/026 United Kingdom ⤷  Try it Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
Boehringer Ingelheim
Express Scripts
AstraZeneca
Johnson and Johnson

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