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PROMACTA Drug Patent Profile

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When do Promacta patents expire, and when can generic versions of Promacta launch?

Promacta is a drug marketed by Novartis and is included in two NDAs. There are twelve patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and seventy-eight patent family members in forty-two countries.

The generic ingredient in PROMACTA 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

Promacta was eligible for patent challenges on November 20, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 1, 2028. This may change due to patent challenges or generic licensing.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for PROMACTA

International Patents:	178
US Patents:	12
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	178
Clinical Trials:	29
Patent Applications:	1,433
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PROMACTA
What excipients (inactive ingredients) are in PROMACTA?	PROMACTA excipients list
DailyMed Link:	PROMACTA at DailyMed

See drug prices for PROMACTA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for PROMACTA

NDA:

022291

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 PROMACTA

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

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

See all PROMACTA clinical trials

Pharmacology for PROMACTA

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

Anatomical Therapeutic Chemical (ATC) Classes for PROMACTA

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

Paragraph IV (Patent) Challenges for PROMACTA

Tradename	Dosage	Ingredient	NDA	Submissiondate
PROMACTA	TABLET;ORAL	eltrombopag olamine	022291	2014-02-04
PROMACTA	TABLET;ORAL	eltrombopag olamine	022291	2014-01-07

US Patents and Regulatory Information for PROMACTA

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

Expired US Patents for PROMACTA

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	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009

International Patents for PROMACTA

Country	Patent Number	Estimated Expiration
Hong Kong	1055561
Australia	7493801
European Patent Office	1864981
European Patent Office	1032387
Iceland	7573

Supplementary Protection Certificates for PROMACTA

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
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
1534390	91 3-2010	Slovakia		PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315
1534390	C20100006	Estonia		PRODUCT NAME: REVOLADE-ELTROMBOPAG; AUTHORISATIN NO.: EMA/CHMP/697489/2018; AUTHORISATION DATE: 20181019