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PROMACTA Drug 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-four patent family members in forty-one 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.

US ANDA Litigation and Generic Entry Outlook for Promacta

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

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:	174
US Patents:	12
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	146
Clinical Trials:	27
Patent Applications:	557
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PROMACTA
DailyMed Link:	PROMACTA at DailyMed

See drug prices for PROMACTA

Recent Clinical Trials for PROMACTA

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

Sponsor	Phase
Shenzhen Second People's Hospital	Phase 3
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Phase 4
Wei Zhao	Phase 4

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

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
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009		RX	Yes	Yes					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009		RX	Yes	Yes

Expired US Patents for PROMACTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-005	Nov 16, 2012
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009

International Patents for PROMACTA

Country	Patent Number	Estimated Expiration
Australia	1295299
Australia	7493801
Malaysia	158072
South Korea	20140049086
Japan	2019123747
Brazil	0111116

Supplementary Protection Certificates for PROMACTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1294378	CA 2010 00017	Denmark
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	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
1294378	300451	Netherlands		PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT (MET INBEGRIP VAN EEN HYDRAAT), IN HET BIJZONDER ELTROMBOPAG OLAMINE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100315
1294378	2010C/018	Belgium		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
1294378	2010/020	Ireland		PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE).; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311