Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
Dow
Express Scripts
McKinsey
Moodys

Last Updated: February 7, 2023

VILTEPSO Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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-one 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

< Available with Subscription >

  Try it Free

Summary for VILTEPSO
International Patents:51
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in VILTEPSO?VILTEPSO excipients list
DailyMed Link:VILTEPSO at DailyMed
Drug patent expirations by year for VILTEPSO
DrugPatentWatch® Estimated 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

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 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 VILTEPSO

Antisense nucleic acids
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting VILTEPSO

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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: 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
Nippon Shinyaku VILTEPSO viltolarsen SOLUTION;INTRAVENOUS 212154-001 Aug 12, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Nippon Shinyaku VILTEPSO viltolarsen SOLUTION;INTRAVENOUS 212154-001 Aug 12, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nippon Shinyaku VILTEPSO viltolarsen SOLUTION;INTRAVENOUS 212154-001 Aug 12, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Nippon Shinyaku VILTEPSO viltolarsen SOLUTION;INTRAVENOUS 212154-001 Aug 12, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing 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

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: See Plans and Pricing

Canada

Patent: 09637
Estimated Expiration: See Plans and Pricing

China

Patent: 3154245
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0160336
Estimated Expiration: See Plans and Pricing

Patent: 0191770
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17367
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 12917
Estimated Expiration: See Plans and Pricing

Patent: 18211
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 12917
Estimated Expiration: See Plans and Pricing

Patent: 18211
Estimated Expiration: See Plans and Pricing

Patent: 43341
Estimated Expiration: See Plans and Pricing

Patent: 81655
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 27321
Estimated Expiration: See Plans and Pricing

Patent: 46364
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2012029986
Estimated Expiration: See Plans and Pricing

Patent: 63655
Estimated Expiration: See Plans and Pricing

Patent: 41728
Estimated Expiration: See Plans and Pricing

Patent: 93343
Estimated Expiration: See Plans and Pricing

Patent: 65932
Estimated Expiration: See Plans and Pricing

Patent: 47430
Estimated Expiration: See Plans and Pricing

Patent: 67619
Estimated Expiration: See Plans and Pricing

Patent: 67620
Estimated Expiration: See Plans and Pricing

Patent: 67621
Estimated Expiration: See Plans and Pricing

Patent: 67636
Estimated Expiration: See Plans and Pricing

Patent: 14054250
Estimated Expiration: See Plans and Pricing

Patent: 16104021
Estimated Expiration: See Plans and Pricing

Patent: 18027083
Estimated Expiration: See Plans and Pricing

Patent: 19062913
Estimated Expiration: See Plans and Pricing

Patent: 20072724
Estimated Expiration: See Plans and Pricing

Patent: 21072820
Estimated Expiration: See Plans and Pricing

Patent: 21072821
Estimated Expiration: See Plans and Pricing

Patent: 21072822
Estimated Expiration: See Plans and Pricing

Patent: 21104037
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 18211
Estimated Expiration: See Plans and Pricing

Poland

Patent: 12917
Estimated Expiration: See Plans and Pricing

Patent: 18211
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 18211
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 67664
Estimated Expiration: See Plans and Pricing

Patent: 13114396
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01600111
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 649
Estimated Expiration: See Plans and Pricing

Patent: 361
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 12917
Estimated Expiration: See Plans and Pricing

Patent: 18211
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1310569
Estimated Expiration: See Plans and Pricing

Patent: 130069762
Estimated Expiration: See Plans and Pricing

Spain

Patent: 67411
Estimated Expiration: See Plans and Pricing

Patent: 50748
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 41024
Estimated Expiration: See Plans and Pricing

Patent: 1215408
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 VILTEPSO around the world.

Country Patent Number Title Estimated Expiration
Japan 6141728 See Plans and Pricing
Japan 5363655 See Plans and Pricing
Japan 6867620 See Plans and Pricing
Japan 2021104037 アンチセンス核酸 (ANTISENSE NUCLEIC ACID) See Plans and Pricing
Japan 2019062913 アンチセンス核酸 (ANTISENSE NUCLEIC ACID) See Plans and Pricing
Japan 6867621 See Plans and Pricing
Taiwan 201215408 Antisense nucleic acid See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Moodys
Merck
Colorcon
McKesson

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.