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 three branded drugs marketed by Annora Pharma and Novartis, and is included in three 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.

Summary for eltrombopag olamine

International Patents:	108
US Patents:	6
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	16
Patent Applications:	465
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for eltrombopag olamine
What excipients (inactive ingredients) are in eltrombopag olamine?	eltrombopag olamine excipients list
DailyMed Link:	eltrombopag olamine at DailyMed

Recent Clinical Trials for eltrombopag olamine

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

Sponsor	Phase
National Taiwan University Hospital	Phase 2
Novartis	Phase 2
Cangzhou Central Hospital	Phase 4

See all eltrombopag olamine clinical trials

Pharmacology for eltrombopag olamine

Drug Class	Thrombopoietin Receptor Agonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Thrombopoietin Receptor Agonists UGT1A1 Inhibitors UGT1A3 Inhibitors UGT1A4 Inhibitors UGT1A6 Inhibitors UGT1A9 Inhibitors UGT2B15 Inhibitors UGT2B7 Inhibitors
Physiological Effect	Increased Megakaryocyte Maturation Increased Platelet Production

Anatomical Therapeutic Chemical (ATC) Classes for eltrombopag olamine

B02BX	Other systemic hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for ELTROMBOPAG OLAMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROMACTA KIT	For Oral Suspension	eltrombopag olamine	12.5 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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Annora Pharma	ELTROMBOPAG OLAMINE	eltrombopag olamine	FOR SUSPENSION;ORAL	216620-001	Apr 18, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008	⤷ Sign Up	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012	⤷ Sign Up	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012	⤷ Sign Up	⤷ Sign Up
Novartis	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

International Patents for eltrombopag olamine

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Country	Patent Number	Title	Estimated Expiration
Peru	20080773	COMPOSICION FARMACEUTICA QUE COMPRENDE BIS-(MONOETANOLAMINA) DE ACIDO 3'-[(2Z)-[1-(3,4-DIMETILFENIL)-1,5-DIHIDRO-3-METIL-5-OXO-4H-PIRAZOL-4-ILIDENO]HIDRAZINO]-2'-HIDROXI-[1,1'-BIFENIL]-3-CARBOXILICO	⤷ Sign Up
China	101686930	Novel pharmaceutical composition	⤷ Sign Up
Chile	2007002242	FORMA DE DOSIFICACION FARMACEUTICA ORAL EN COMPRIMIDO, CAPSULA O GRANULO QUE COMPRENDE BIS-(MONOETANOLAMINA) DE ACIDO 3'-[(2Z)-[1-(3,4-DIMETILFENIL)-1,5-DIHIDRO-3-METIL-5-OXO-4H-PIRAZOL-4-ILIDENO]HIDRAZINO]-2'-HIDROXI[1-1'-BIFENIL]-3-CARBOXILICO; PRO	⤷ Sign Up
New Zealand	580888	Compositions of eltrombopag olamine substantially free from coordinating metals or reducing sugars	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for eltrombopag olamine

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1294378	C201000022	Spain	⤷ Sign Up	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	C300451	Netherlands	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
1534390	91 3-2010	Slovakia	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315
1294378	23/2010	Austria	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS UND SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/612/001-EU/1/10/612/006 (MITTEILUNG) 20100315
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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