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Last Updated: May 29, 2024

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VILTEPSO Drug Patent 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 are two patents protecting this drug.

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

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

DrugPatentWatch® 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:53
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Drug Prices: Drug price information for VILTEPSO
What excipients (inactive ingredients) are in VILTEPSO?VILTEPSO excipients list
DailyMed Link:VILTEPSO at DailyMed
Drug patent expirations by year for VILTEPSO
Drug Prices for VILTEPSO

See drug prices for VILTEPSO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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

VILTEPSO is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VILTEPSO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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 VILTEPSO

Antisense nucleic acids
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING

Antisense nucleic acids
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting VILTEPSO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

INDICATED FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING
Exclusivity Expiration: ⤷  Sign Up

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

International Patents for VILTEPSO

When does loss-of-exclusivity occur for VILTEPSO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 11296882
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 09637
Estimated Expiration: ⤷  Sign Up

China

Patent: 3154245
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0160336
Estimated Expiration: ⤷  Sign Up

Patent: 0191770
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 17367
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 12917
Estimated Expiration: ⤷  Sign Up

Patent: 18211
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 12917
Estimated Expiration: ⤷  Sign Up

Patent: 18211
Estimated Expiration: ⤷  Sign Up

Patent: 43341
Estimated Expiration: ⤷  Sign Up

Patent: 81655
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 27321
Estimated Expiration: ⤷  Sign Up

Patent: 46364
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 2012029986
Estimated Expiration: ⤷  Sign Up

Patent: 63655
Estimated Expiration: ⤷  Sign Up

Patent: 41728
Estimated Expiration: ⤷  Sign Up

Patent: 93343
Estimated Expiration: ⤷  Sign Up

Patent: 65932
Estimated Expiration: ⤷  Sign Up

Patent: 47430
Estimated Expiration: ⤷  Sign Up

Patent: 67619
Estimated Expiration: ⤷  Sign Up

Patent: 67620
Estimated Expiration: ⤷  Sign Up

Patent: 67621
Estimated Expiration: ⤷  Sign Up

Patent: 67636
Estimated Expiration: ⤷  Sign Up

Patent: 14054250
Estimated Expiration: ⤷  Sign Up

Patent: 16104021
Estimated Expiration: ⤷  Sign Up

Patent: 18027083
Estimated Expiration: ⤷  Sign Up

Patent: 19062913
Estimated Expiration: ⤷  Sign Up

Patent: 20072724
Estimated Expiration: ⤷  Sign Up

Patent: 21072820
Estimated Expiration: ⤷  Sign Up

Patent: 21072821
Estimated Expiration: ⤷  Sign Up

Patent: 21072822
Estimated Expiration: ⤷  Sign Up

Patent: 21104037
Estimated Expiration: ⤷  Sign Up

Patent: 23036865
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 18211
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 12917
Estimated Expiration: ⤷  Sign Up

Patent: 18211
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 18211
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 67664
Estimated Expiration: ⤷  Sign Up

Patent: 13114396
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01600111
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 649
Estimated Expiration: ⤷  Sign Up

Patent: 361
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 12917
Estimated Expiration: ⤷  Sign Up

Patent: 18211
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1310569
Estimated Expiration: ⤷  Sign Up

Patent: 130069762
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 67411
Estimated Expiration: ⤷  Sign Up

Patent: 50748
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 41024
Estimated Expiration: ⤷  Sign Up

Patent: 1215408
Estimated Expiration: ⤷  Sign Up

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 VILTEPSO around the world.

Country Patent Number Title Estimated Expiration
Spain 2750748 ⤷  Sign Up
Cyprus 1122167 ⤷  Sign Up
Lithuania 3018211 ⤷  Sign Up
South Korea 101310569 ⤷  Sign Up
San Marino T201600111 ACIDI NUCLEICI ANTISENSO ⤷  Sign Up
Cyprus 1117367 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.