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Last Updated: October 30, 2020

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VILTEPSO Drug Profile

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Which patents cover Viltepso, and when can generic versions of Viltepso launch?

Viltepso is a drug marketed by Nippon Shinyaku and is included in one NDA. There is one patent protecting this drug.

This drug has forty-three patent family members in twenty countries.

The generic ingredient in VILTEPSO is viltolarsen. Additional details are available on the viltolarsen profile page.

US ANDA Litigation and Generic Entry Outlook for Viltepso

Viltepso will be eligible for patent challenges on August 12, 2024. 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 August 31, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VILTEPSO
International Patents:43
US Patents:1
Applicants:1
NDAs:1
DailyMed Link:VILTEPSO at DailyMed
Drug patent expirations by year for VILTEPSO
Generic Entry Opportunity Date for VILTEPSO
Generic Entry Date for VILTEPSO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*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 VILTEPSO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nippon Shinyaku VILTEPSO viltolarsen SOLUTION;INTRAVENOUS 212154-001 Aug 12, 2020 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Nippon Shinyaku VILTEPSO viltolarsen SOLUTION;INTRAVENOUS 212154-001 Aug 12, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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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.