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MULPLETA Drug Patent Profile

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

Mulpleta is a drug marketed by Vancocin Italia and is included in one NDA. There are four patents protecting this drug.

This drug has fifty-six patent family members in twenty countries.

The generic ingredient in MULPLETA is lusutrombopag. One supplier is listed for this compound. Additional details are available on the lusutrombopag profile page.

DrugPatentWatch^® Generic Entry Outlook for Mulpleta

Mulpleta was eligible for patent challenges on July 31, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 29, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MULPLETA

International Patents:	56
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Patent Applications:	24
Drug Prices:	Drug price information for MULPLETA
What excipients (inactive ingredients) are in MULPLETA?	MULPLETA excipients list
DailyMed Link:	MULPLETA at DailyMed

See drug prices for MULPLETA

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

NDA:

210923

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.

Anatomical Therapeutic Chemical (ATC) Classes for MULPLETA

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

US Patents and Regulatory Information for MULPLETA

MULPLETA is protected by four US patents.

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 MULPLETA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923-001	Jul 31, 2018		RX	Yes	Yes			Y	Y
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923-001	Jul 31, 2018		RX	Yes	Yes			Y	Y
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923-001	Jul 31, 2018		RX	Yes	Yes			Y
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923-001	Jul 31, 2018		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for MULPLETA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Shionogi B.V.	Mulpleo (previously Lusutrombopag Shionogi)	lusutrombopag	EMEA/H/C/004720 Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures	Authorised	no	no	no	2019-02-18

International Patents for MULPLETA

When does loss-of-exclusivity occur for MULPLETA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Brazil

Canada

China

European Patent Office

Japan

Russian Federation

South Korea

Spain

Taiwan

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

See the table below for additional patents covering MULPLETA around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	201216962	Formulation for solubility enhancement of poorly soluble drugs
South Korea	101849808
World Intellectual Property Organization (WIPO)	2012043709
China	103396313	Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity and intermediate thereof
Australia	2008283357	Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity and intermediate thereof
Brazil	PI0814891	Composição farmacêutica contendo composto oticamente ativo tendo atividade agonista de receptor de trombopoietina, e intermediário do mesmo.
Croatia	P20150062

Supplementary Protection Certificates for MULPLETA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2184279	SPC/GB19/049	United Kingdom		PRODUCT NAME: LUSUTROMBOPAG, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/18/1348(FOR NI) 20190220; UK PLGB 50999/0007 20190220
2184279	132019000000090	Italy		PRODUCT NAME: LUSUTROMBOPAG(LUSUTROMBOPAG SHIONOGI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1348, 20190220
2184279	300998	Netherlands		PRODUCT NAME: LUSUTROMBOPAG OF FARMACEUTISCH AANVAARDBARE ZOUTEN OF SOLVATEN DAARVAN; REGISTRATION NO/DATE: EU/1/18/1348 20190220
2184279	2019C/534	Belgium		PRODUCT NAME: LUSUTROMBOPAG OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1348 20190220
2184279	C201930048	Spain		PRODUCT NAME: LUSUTROMBOPAG; NATIONAL AUTHORISATION NUMBER: EU/01/18/1348; DATE OF AUTHORISATION: 20190218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/01/18/1348; DATE OF FIRST AUTHORISATION IN EEA: 20190218
2184279	CA 2019 00038	Denmark		PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1348 20190220
2184279	CR 2019 00038	Denmark		PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1348 20190220