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Last Updated: April 21, 2024

Eltrombopag olamine - Generic Drug Details


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What are the generic sources for eltrombopag olamine and what is the scope of freedom to operate?

Eltrombopag olamine is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are six 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 eight patent family members in forty countries.

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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for eltrombopag olamine
Generic Entry Dates for eltrombopag olamine*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION;ORAL
Generic Entry Dates for eltrombopag olamine*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for eltrombopag olamine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shenyang Sunshine Pharmaceutical Co., LTD.Phase 4
Yuncheng Central HospitalPhase 4
Second Affiliated Hospital of Guangzhou Medical UniversityPhase 4

See all eltrombopag olamine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for eltrombopag olamine
Paragraph IV (Patent) Challenges for ELTROMBOPAG OLAMINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PROMACTA KIT For Oral Suspension eltrombopag olamine 12. mg/packet and 25 mg/packet 207027 1 2022-04-22
PROMACTA Tablets eltrombopag olamine 12.5 mg and 25 mg 022291 1 2014-02-04
PROMACTA Tablets eltrombopag olamine 50 mg and 75 mg 022291 1 2014-01-07

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 PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 eltrombopag olamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for eltrombopag olamine

Country Patent Number Title Estimated Expiration
Malaysia 142390 3' - [(2Z)-[1-(3,4-DIMETHYLPHENYL)-1,5- DIHYDRO-3- METHYL-5-0XO-4H-PYRAZOL-4- YLIDENE]HYDRAZINO]-2' -HYDROXY -[1,1' -BIPHENYL]-3-CARBOXYLIC ACID BIS-(MONOETHANOLAMINE) ⤷  Try a Trial
Lithuania C1534390 ⤷  Try a Trial
Israel 199438 USE OF 3' -[(2Z) -[1-(3,4-DIMETHYLPHENYL)-1,5-DIHYDRO-3-METHYL-5-OXO-4H- PYRAZOL-4-YLIDENE] HYDRAZINE]-2'-HYDROXY-[1,1'-BIPHENYL]-3- CARBOXYLIC ACID BIS-(MONOETHANOLAMINE) IN THE PREPARATION OF MEDICAMENTS FOR TREATING THROMBOCYTOPENIA AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME ⤷  Try a Trial
China 102697745 Novel pharmaceutical composition ⤷  Try a Trial
Cyprus 1109912 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for eltrombopag olamine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534390 C 2010 013 Romania ⤷  Try a Trial 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 SPC/GB10/026 United Kingdom ⤷  Try a Trial PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE); REGISTERED: UK EU1/10/612/001 20100315; UK EU1/10/612/002 20100315; UK EU1/10/612/003 20100315; UK EU1/10/612/004 20100315; UK EU1/10/612/005 20100315; UK EU1/10/612/006 20100315
1534390 PA2010007 Lithuania ⤷  Try a Trial 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
1294378 2010C/018 Belgium ⤷  Try a 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
1534390 PA2010007,C1534390 Lithuania ⤷  Try a Trial PRODUCT NAME: ELTROMBOPAGO OLAMINAS; 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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