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Last Updated: November 18, 2019

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PROMACTA Drug Profile

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When do Promacta patents expire, 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-one patent family members in forty 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.

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 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 022291-005 Nov 16, 2012   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011   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 022291-002 Nov 20, 2008   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 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
1294378 91681 Luxembourg   Start Trial 91681, EXPIRES: 20250311
1294378 C01294378/01 Switzerland   Start Trial FORMER OWNER: GLAXOSMITHKLINE LLC, US
1534390 C20100006 00032 Estonia   Start Trial PRODUCT NAME: REVOLADE-ELTROMBOPAG; REG NO/DATE: C(2010)1662 11.03.2010
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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