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Last Updated: December 3, 2020

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MULPLETA Drug 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-three patent family members in eighteen countries.

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

US ANDA Litigation and Generic Entry Outlook for Mulpleta

Mulpleta will be eligible for patent challenges on July 31, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:53
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 26
Patent Applications: 6
Drug Prices: Drug price information for MULPLETA
DailyMed Link:MULPLETA at DailyMed
Drug patent expirations by year for MULPLETA
Drug Prices for MULPLETA

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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

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

Supplementary Protection Certificates for MULPLETA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2184279 2019/039 Ireland   Start Trial PRODUCT NAME: LUSUTROMBOPAG, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE THEREOF.; REGISTRATION NO/DATE: EU/1/18/1348 20190218
2184279 1990035-6 Sweden   Start Trial PRODUCT NAME: LUSUTROMBOPAG; REG. NO/DATE: EU/1/18/1348 20190220
2184279 122019000065 Germany   Start Trial PRODUCT NAME: LUSUTROMBOPAG; REGISTRATION NO/DATE: EU/1/18/1348 20190218
>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.