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Generated: August 24, 2019

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Eltrombopag olamine - Generic Drug Details

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What are the generic sources for eltrombopag olamine and what is the scope of eltrombopag olamine patent protection?

Eltrombopag olamine is the generic ingredient in two branded drugs marketed by Novartis Pharms Corp and is included in two NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Eltrombopag olamine has one hundred and eighty-nine patent family members in forty countries.

There are three drug master file entries for eltrombopag olamine. One supplier is listed for this compound.

Summary for eltrombopag olamine

US Patents and Regulatory Information for eltrombopag olamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Expired US Patents for eltrombopag olamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 ➤ Sign Up ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Supplementary Protection Certificates for eltrombopag olamine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1294378 10C0034 France ➤ Sign Up 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 122010000037 Germany ➤ Sign Up PRODUCT NAME: ELTROMBOPAG SOWIE PHARMAZEUTISCH ANNEHMBARE SALZE, HYDRATE UND SOLVATE DAVON; NAT. REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311; FIRST REGISTRATION: EU EU/1/10/612/001-/006 20100311
1294378 C01294378/01 Switzerland ➤ Sign Up FORMER OWNER: GLAXOSMITHKLINE LLC, US
1534390 PA2010007 Lithuania ➤ Sign Up PRODUCT NAME: ELTROMBOPAGUM OLAMINUM; 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
1534390 C 2010 013 Romania ➤ Sign Up PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/612/001, RO EU/1/10/612/002, RO EU/1/10/612/003, RO EU/1/10/612/004, RO EU/1/10/612/005, RO EU/1/10/612/006; DATE OF NATIONAL AUTHORISATION: 20100311; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/612/001, EMEA EU/1/10/612/002, EMEA EU/1/10/612/003, EMEA EU/1/10/612/004, EMEA EU/1/10/612/005, EMEA EU/1/10/612/006; DATE OF FIRST AUTHORISATION IN EEA: 20100311
1294378 388 Finland ➤ Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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