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Last Updated: September 30, 2022

MULPLETA Drug Patent Profile


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

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

This drug has fifty-four patent family members in nineteen 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

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Summary for MULPLETA
International Patents:54
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 32
Patent Applications: 35
Drug Prices: Drug price information for MULPLETA
What excipients (inactive ingredients) are in MULPLETA?MULPLETA excipients list
DailyMed Link:MULPLETA at DailyMed
Drug patent expirations by year for MULPLETA
Drug Prices for MULPLETA

See drug prices for MULPLETA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for MULPLETA
Generic Entry Date for MULPLETA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for MULPLETA

MULPLETA is protected by four US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MULPLETA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Compounds exhibiting thrombopoietin receptor agonism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC LIVER DISEASE WHO ARE SCHEDULED TO UNDERGO A PROCEDURE

Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Preparation for improving solubility of poorly soluble drug
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting MULPLETA

NEW CHEMICAL ENTITY
Exclusivity Expiration: 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
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
>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 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 2013007364
Estimated Expiration: See Plans and Pricing

Canada

Patent: 13147
Estimated Expiration: See Plans and Pricing

China

Patent: 3228277
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 23100
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2012043709
Estimated Expiration: See Plans and Pricing

Patent: 57146
Estimated Expiration: See Plans and Pricing

Patent: 94650
Estimated Expiration: See Plans and Pricing

Patent: 14141518
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 13119966
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1849808
Estimated Expiration: See Plans and Pricing

Patent: 130115257
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 64008
Estimated Expiration: See Plans and Pricing

Patent: 1216962
Estimated Expiration: See Plans and Pricing

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
China 103228277 Preparation for improving solubility of poorly soluble drug See Plans and Pricing
Japan 5557146 See Plans and Pricing
Japan 4106066 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MULPLETA

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 C201930048 Spain See Plans and Pricing 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 300998 Netherlands See Plans and Pricing PRODUCT NAME: LUSUTROMBOPAG OF FARMACEUTISCH AANVAARDBARE ZOUTEN OF SOLVATEN DAARVAN; REGISTRATION 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:

Express Scripts
AstraZeneca
Moodys
Baxter
Dow
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.