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-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
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 |

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.
Anatomical Therapeutic Chemical (ATC) Classes for VILTEPSO
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 |