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Last Updated: July 12, 2020

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PROMACTA Drug Profile


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When do Promacta patents expire, and when can generic versions of Promacta launch?

Promacta is a drug marketed by Novartis and is included in two NDAs. There are twelve patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and seventy-four patent family members in forty-one countries.

The generic ingredient in PROMACTA 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

Promacta was eligible for patent challenges on November 20, 2012.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for PROMACTA
Drug Prices for PROMACTA

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Recent Clinical Trials for PROMACTA

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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 clinical trials

Paragraph IV (Patent) Challenges for PROMACTA
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 PROMACTA

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 eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 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   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 022291-003 Sep 8, 2009 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

Expired US Patents for PROMACTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011   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 022291-001 Nov 20, 2008   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PROMACTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1294378 CA 2010 00017 Denmark   Start Trial
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 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
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 2010/020 Ireland   Start Trial PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE).; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Baxter
Johnson and Johnson
Boehringer Ingelheim
Merck

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