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 Vancocin Italia and is included in one NDA. There are three patents protecting this drug.
This drug has forty-one 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
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Questions you can ask:
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Summary for MULPLETA
International Patents: | 41 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 41 |
Patent Applications: | 16 |
Drug Prices: | Drug price information for MULPLETA |
What excipients (inactive ingredients) are in MULPLETA? | MULPLETA excipients list |
DailyMed Link: | MULPLETA at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MULPLETA is ⤷ Try for Free.
This potential generic entry date is based on patent 9,427,402.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 9,427,402 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Vancocin Italia | MULPLETA | lusutrombopag | TABLET;ORAL | 210923-001 | Jul 31, 2018 | RX | Yes | Yes | 8,889,722 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Vancocin Italia | MULPLETA | lusutrombopag | TABLET;ORAL | 210923-001 | Jul 31, 2018 | RX | Yes | Yes | 8,530,668 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
>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 MULPLETA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Vancocin Italia | MULPLETA | lusutrombopag | TABLET;ORAL | 210923-001 | Jul 31, 2018 | 7,601,746 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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
Patent: preparação para melhorar a solubilidade para um fármaco pouco solúvel
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 13147
Patent: PREPARATION POUR AMELIORER LA SOLUBILITE D'UN MEDICAMENT MEDIOCREMENT SOLUBLE (PREPARATION FOR IMPROVING SOLUBILITY OF POORLY SOLUBLE DRUG)
Estimated Expiration: ⤷ Try for Free
China
Patent: 3228277
Patent: Preparation for improving solubility of poorly soluble drug
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 23100
Patent: PRÉPARATION POUR AMÉLIORER LA SOLUBILITÉ D'UN MÉDICAMENT MÉDIOCREMENT SOLUBLE (PREPARATION FOR IMPROVING SOLUBILITY OF POORLY SOLUBLE DRUG)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 2012043709
Patent: 難溶性薬物の溶解性改善製剤
Estimated Expiration: ⤷ Try for Free
Patent: 57146
Estimated Expiration: ⤷ Try for Free
Patent: 94650
Estimated Expiration: ⤷ Try for Free
Patent: 14141518
Patent: PREPARATION FOR IMPROVING SOLUBILITY OF POORLY SOLUBLE DRUG
Estimated Expiration: ⤷ Try for Free
Russian Federation
Patent: 13119966
Patent: КОМПОЗИЦИЯ, УЛУЧШАЮЩАЯ РАСТВОРИМОСТЬ ПЛОХОРАСТВОРИМОГО ЛЕКАРСТВЕННОГО ПРЕПАРАТА
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 1849808
Estimated Expiration: ⤷ Try for Free
Patent: 130115257
Patent: PREPARATION FOR IMPROVING SOLLUBILITY OF POORLY SOLUBLE DRUG
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 49552
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 64008
Estimated Expiration: ⤷ Try for Free
Patent: 1216962
Patent: Formulation for solubility enhancement of poorly soluble drugs
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Denmark | 2184279 | ⤷ Try for Free | |
Japan | 2014141518 | PREPARATION FOR IMPROVING SOLUBILITY OF POORLY SOLUBLE DRUG | ⤷ Try for Free |
Portugal | 2184279 | ⤷ Try for Free | |
South Korea | 101849808 | ⤷ Try for Free | |
South Korea | 20100027243 | PHARMACEUTICAL COMPOSITION CONTAINING OPTICALLY ACTIVE COMPOUND HAVING THROMBOPOIETIN RECEPTOR AGONIST ACTIVITY AND INTERMEDIATE THEREOF | ⤷ Try for Free |
Taiwan | 200914000 | Pharmaceutical composition containing optically active compounds exhibiting thrombopoietin receptor agonism and their intermediates | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MULPLETA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2184279 | 122019000065 | Germany | ⤷ Try for Free | PRODUCT NAME: LUSUTROMBOPAG; REGISTRATION NO/DATE: EU/1/18/1348 20190218 |
2184279 | 1990035-6 | Sweden | ⤷ Try for Free | PRODUCT NAME: LUSUTROMBOPAG; REG. NO/DATE: EU/1/18/1348 20190220 |
2184279 | 19C1043 | France | ⤷ Try for Free | 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 | ⤷ Try for Free | PRODUCT NAME: LUSUTROMBOPAG OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1348 20190220 |
2184279 | C201930048 | Spain | ⤷ Try for Free | 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 | ⤷ Try for Free | 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 |
Market Dynamics and Financial Trajectory for MULPLETA
More… ↓