PROMACTA KIT Drug Patent Profile

Which patents cover Promacta Kit, and what generic alternatives are available?

Promacta Kit is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifteen patent family members in thirty-one countries.

The generic ingredient in PROMACTA KIT 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.

DrugPatentWatch^® Generic Entry Outlook for Promacta Kit

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 13, 2026. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for PROMACTA KIT

International Patents:	115
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	31
Formulation / Manufacturing:	see details
DailyMed Link:	PROMACTA KIT at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for PROMACTA KIT

NDA:

207027

Dosage:

FOR SUSPENSION;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 PROMACTA KIT

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

Sponsor	Phase
Food and Drug Administration (FDA)	Phase 1
University of California, San Francisco	Phase 1
Anjali Pawar	Phase 1

See all PROMACTA KIT clinical trials

Pharmacology for PROMACTA KIT

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 PROMACTA KIT

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

Paragraph IV (Patent) Challenges for PROMACTA KIT

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

US Patents and Regulatory Information for PROMACTA KIT

PROMACTA KIT is protected by three US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PROMACTA KIT

FDA Regulatory Exclusivity protecting PROMACTA KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018		RX	Yes	No					Y
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015		RX	Yes	Yes					Y
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018		RX	Yes	No
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015		RX	Yes	Yes					Y
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018		RX	Yes	No					Y
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018		RX	Yes	No					Y

Expired US Patents for PROMACTA KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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 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 KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015

International Patents for PROMACTA KIT

See the table below for patents covering PROMACTA KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	1295299
Argentina	040083	COMPUESTO BIS-(MONOETANOLAMINA) DEL ACIDO 3'-[(2Z)-[1-(3,4-DIMETILFENIL) -1,5-DIHIDRO-3-METIL-5-OXO-4H-PIRAZOL-4-ILIDEN] HIDRAZINO] -2'-HIDROXI-[1,1'-BIFENIL]-3-CARBOXILICO, PROCEDIMIENTO PARA PREPARARLO, COMPOSICION FARMACEUTICA QUE LO COMPRENDE, PROCEDIMIENTO PARA PREPARAR DICHA COMPOSICION FARMAC
Mexico	PA02011621	MIMETICOS DE TROMBOPOYETINA. (THROMBOPOIETIN MIMETICS.)
Israel	152988	3' - {N' - [1 - (3,4 - DIMETHYLPHENYL) - 3 - METHYL - 5 - OXO - 1,5 - DIHYDROPYRAZOL - 4 - YLIDENE] HYDRAZINE} - 2' - HYDROXY - BIPHENYL - 3 - CARBOXYLIC ACID, 3' - {N' -[1- (3,4 - DIMETHYLPHENYL) - 3 - METHYL - 5 - OXO - 1,5 - DIHYDROPYRAZOL - 4 - YLIDENE] HYDRAZINE} - 2' - HYDROXY - 3' - (TETRAZOL - 5 - YL) - BIPHENYL COMPOUNDS AND THEIR DERIVATIVES AND THEIR USE IN THE PREPARATION OF PHARMACEUTICAL COMPOSITIONS FOR TREATMENT OF HEMATOPOIETIC DISORDERS
Australia	2001274938
Spain	2294000

Supplementary Protection Certificates for PROMACTA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1294378	CA 2010 00017	Denmark
1534390	91 3-2010	Slovakia		PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315
1294378	10C0034	France		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	388	Finland
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	C300451	Netherlands		PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311