ELTROMBOPAG OLAMINE - Generic Drug Details

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.

Summary for ELTROMBOPAG OLAMINE

International Patents:	108
US Patents:	6
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	15
Patent Applications:	564
Formulation / Manufacturing:	see details
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ELTROMBOPAG OLAMINE

Dosage:

FOR SUSPENSION;ORAL

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

Sponsor	Phase
Daqing Oil Field Hospital	Phase 4
The Affiliated Hospital of Inner Mongolia Medical University	Phase 4
Shaanxi Provincial People's 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

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	022291-001	Nov 20, 2008		RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012		DISCN	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008		RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011		RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008		RX	Yes	No					Y

Expired US Patents for ELTROMBOPAG OLAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011

International Patents for ELTROMBOPAG OLAMINE

Country	Patent Number	Title	Estimated Expiration
Cyprus	1109912
Lithuania	PA2010007
Russian Federation	2004137491	БИС-(МОНОЭТАНОЛАМИН) 3`-[(2Z)-[1-(3,4-ДИМЕТИЛФЕНИЛ)-1,5-ДИГИДРО-3-МЕТИЛ-5-ОКСО-4H-ПИРАЗОЛ-4- ИЛДЕН] ГИДРАЗИНО]-2`-ГИДРОКСИ-[1,1`-БИФЕНИЛ]-3-КАРБОНОВОЙ КИСЛОТЫ
Israel	164966
Iceland	2770

Supplementary Protection Certificates for ELTROMBOPAG OLAMINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534390	C 2010 013	Romania		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
1534390	PA2010007,C1534390	Lithuania		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
1294378	23/2010	Austria		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
1294378	122010000037	Germany		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	C201000022	Spain		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