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Last Updated: June 4, 2020

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PROMACTA KIT Drug Profile


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Which patents cover Promacta Kit, and what generic alternatives are available?

Promacta Kit is a drug marketed by Novartis and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and fourteen patent family members in thirty-one countries.

The generic ingredient in PROMACTA KIT is eltrombopag olamine. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eltrombopag olamine profile page.

US ANDA Litigation and Generic Entry Outlook for Promacta Kit

Indicators of Generic Entry

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Summary for PROMACTA KIT
International Patents:114
US Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 27
Formulation / Manufacturing:see details
DailyMed Link:PROMACTA KIT at DailyMed
Drug patent expirations by year for PROMACTA KIT
Recent Clinical Trials for PROMACTA KIT

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SponsorPhase
Shenzhen Second People's HospitalPhase 3
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 4
Wei ZhaoPhase 4

See all PROMACTA KIT clinical trials

US Patents and Regulatory Information for PROMACTA KIT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes   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

Supplementary Protection Certificates for PROMACTA KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1294378 388 Finland   Start Trial
1294378 C01294378/01 Switzerland   Start Trial FORMER OWNER: GLAXOSMITHKLINE LLC, US
1294378 SPC/GB10/026 United Kingdom   Start Trial 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 PA2010007,C1534390 Lithuania   Start Trial PRODUCT NAME: ELTROMBOPAGO OLAMINAS; 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 C201000022 Spain   Start Trial PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: EU/1/10/612/001-006; DATE OF AUTHORISATION: 20100315; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/10/612/001-006; DATE OF FIRST AUTHORISATION IN EEA: 20100315
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Medtronic
Boehringer Ingelheim
Dow
Baxter

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