LUSUTROMBOPAG - Generic Drug Details

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What are the generic drug sources for lusutrombopag and what is the scope of freedom to operate?

Lusutrombopag is the generic ingredient in one branded drug marketed by Vancocin Italia and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lusutrombopag has fifty-six patent family members in twenty countries.

One supplier is listed for this compound.

Summary for LUSUTROMBOPAG

International Patents:	56
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	3
Patent Applications:	45
What excipients (inactive ingredients) are in LUSUTROMBOPAG?	LUSUTROMBOPAG excipients list
DailyMed Link:	LUSUTROMBOPAG at DailyMed

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

Generic Entry Date for LUSUTROMBOPAG^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 LUSUTROMBOPAG

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

Sponsor	Phase
Shionogi	Phase 3
Shionogi	Phase 2

See all LUSUTROMBOPAG clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LUSUTROMBOPAG

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

US Patents and Regulatory Information for LUSUTROMBOPAG

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Glossary

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

Expired US Patents for LUSUTROMBOPAG

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923-001	Jul 31, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for LUSUTROMBOPAG

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for LUSUTROMBOPAG

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Country	Patent Number	Title	Estimated Expiration
South Korea	101849808		⤷ Sign Up
Mexico	2010001082	COMPOSICION FARMACEUTICA QUE CONTIENE COMPUESTO OPTICAMENTE ACTIVO QUE TIENE ACTIVIDAD AGONISTA DEL RECEPTOR DE TROMBOPOYETINA Y COMPUESTO INTERMEDIO PARA EL MISMO. (PHARMACEUTICAL COMPOSITION CONTAINING OPTICALLY ACTIVE COMPOUND HAVING THROMBOPOIETIN RECEPTOR AGONIST ACTIVITY AND INTERMEDIATE THEREOF.)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2012043709		⤷ Sign Up
Japan	2014141518	PREPARATION FOR IMPROVING SOLUBILITY OF POORLY SOLUBLE DRUG	⤷ Sign Up
Netherlands	300998		⤷ Sign Up
China	103393678	Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity and intermediate thereof	⤷ Sign Up
South Korea	20130115257	PREPARATION FOR IMPROVING SOLLUBILITY OF POORLY SOLUBLE DRUG	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LUSUTROMBOPAG

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2184279	SPC/GB19/049	United Kingdom	⤷ Sign Up	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	CA 2019 00038	Denmark	⤷ Sign Up	PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1348 20190220
2184279	C201930048	Spain	⤷ Sign Up	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	1990035-6	Sweden	⤷ Sign Up	PRODUCT NAME: LUSUTROMBOPAG; REG. NO/DATE: EU/1/18/1348 20190220
2184279	122019000065	Germany	⤷ Sign Up	PRODUCT NAME: LUSUTROMBOPAG; REGISTRATION NO/DATE: EU/1/18/1348 20190218
2184279	19C1043	France	⤷ Sign Up	PRODUCT NAME: LUSUTROMBOPAG, UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI OU UN SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/18/1348 20190220
2184279	2019C/534	Belgium	⤷ Sign Up	PRODUCT NAME: LUSUTROMBOPAG OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1348 20190220
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Summary for LUSUTROMBOPAG

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LUSUTROMBOPAG

Recent Clinical Trials for LUSUTROMBOPAG

Anatomical Therapeutic Chemical (ATC) Classes for LUSUTROMBOPAG

Make Better Decisions: Try a trial or see plans & pricing

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