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Last Updated: January 28, 2020

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PROMACTA KIT Drug Profile

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When do Promacta Kit patents expire, and what generic alternatives are available?

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

This drug has one hundred and thirty-five 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

Promacta Kit was eligible for patent challenges on December 31, 1968.

Indicators of Generic Entry

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Summary for PROMACTA KIT
International Patents:135
US Patents:8
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
Wei ZhaoPhase 4
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 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
>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 10C0034 France   Start Trial 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 91681 Luxembourg   Start 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
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 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 20100311; UK EU1/10/612/002 20100311; UK EU1/10/612/003 20100311; UK EU1/10/612/004 20100311; UK EU1/10/612/005 20100311; UK EU1/10/612/006 20100311
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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