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Last Updated: January 29, 2020

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PROMACTA Drug Profile

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

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

This drug has one hundred and ninety-three 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
Wei ZhaoPhase 4
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 4

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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 eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 DISCN 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 022291-001 Nov 20, 2008 RX Yes No   Start Trial   Start Trial   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 eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 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

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 C01294378/01 Switzerland   Start Trial FORMER OWNER: GLAXOSMITHKLINE LLC, US
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 C300451 Netherlands   Start Trial PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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