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Last Updated: June 28, 2022

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 Shionogi Inc 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-four patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for lusutrombopag
International Patents:54
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 31
Clinical Trials: 3
Patent Applications: 58
What excipients (inactive ingredients) are in lusutrombopag?lusutrombopag excipients list
DailyMed Link:lusutrombopag at DailyMed
Recent Clinical Trials for lusutrombopag

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

SponsorPhase
ShionogiPhase 3
ShionogiPhase 2

See all lusutrombopag clinical trials

US Patents and Regulatory Information for lusutrombopag

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

EU/EMA Drug Approvals for lusutrombopag

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

Country Patent Number Title Estimated Expiration
Denmark 2184279 See Plans and Pricing
Japan 5794650 See Plans and Pricing
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.) See Plans and Pricing
South Korea 20130115257 PREPARATION FOR IMPROVING SOLLUBILITY OF POORLY SOLUBLE DRUG See Plans and Pricing
Canada 2694567 COMPOSITION PHARMACEUTIQUE CONTENANT UN COMPOSE ACTIF SUR LE PLAN OPTIQUE POSSEDANT UNE ACTIVITE D'AGONISTE DU RECEPTEUR DE LA THROMBOPOIETINE ET SON INTERMEDIAIRE (PHARMACEUTICAL COMPOSITION CONTAINING OPTICALLY ACTIVE COMPOUND HAVING THROMBOPOIETIN RECEPTOR AGONIST ACTIVITY AND INTERMEDIATE THEREOF) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lusutrombopag

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2184279 2019/039 Ireland See Plans and Pricing PRODUCT NAME: LUSUTROMBOPAG, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE THEREOF.; REGISTRATION NO/DATE: EU/1/18/1348 20190218
2184279 2019C/534 Belgium See Plans and Pricing PRODUCT NAME: LUSUTROMBOPAG OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1348 20190220
2184279 CA 2019 00038 Denmark See Plans and Pricing PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1348 20190220
2184279 122019000065 Germany See Plans and Pricing PRODUCT NAME: LUSUTROMBOPAG; REGISTRATION NO/DATE: EU/1/18/1348 20190218
2184279 CR 2019 00038 Denmark See Plans and Pricing PRODUCT NAME: LUSUTROMBOPAG OG FARMACEUTISK ACCEPTABLE SALTE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1348 20190220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Harvard Business School
McKesson
Express Scripts
Johnson and Johnson

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.