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-two 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: | 52 |
| 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 |
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.
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting VILTEPSO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Nippon Shinyaku | VILTEPSO | viltolarsen | SOLUTION;INTRAVENOUS | 212154-001 | Aug 12, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Nippon Shinyaku | VILTEPSO | viltolarsen | SOLUTION;INTRAVENOUS | 212154-001 | Aug 12, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Nippon Shinyaku | VILTEPSO | viltolarsen | SOLUTION;INTRAVENOUS | 212154-001 | Aug 12, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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: ⤷ Try a Trial
Canada
Patent: 09637
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3154245
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0160336
Estimated Expiration: ⤷ Try a Trial
Patent: 0191770
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 17367
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 12917
Estimated Expiration: ⤷ Try a Trial
Patent: 18211
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 12917
Estimated Expiration: ⤷ Try a Trial
Patent: 18211
Estimated Expiration: ⤷ Try a Trial
Patent: 43341
Estimated Expiration: ⤷ Try a Trial
Patent: 81655
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 27321
Estimated Expiration: ⤷ Try a Trial
Patent: 46364
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 2012029986
Estimated Expiration: ⤷ Try a Trial
Patent: 63655
Estimated Expiration: ⤷ Try a Trial
Patent: 41728
Estimated Expiration: ⤷ Try a Trial
Patent: 93343
Estimated Expiration: ⤷ Try a Trial
Patent: 65932
Estimated Expiration: ⤷ Try a Trial
Patent: 47430
Estimated Expiration: ⤷ Try a Trial
Patent: 67619
Estimated Expiration: ⤷ Try a Trial
Patent: 67620
Estimated Expiration: ⤷ Try a Trial
Patent: 67621
Estimated Expiration: ⤷ Try a Trial
Patent: 67636
Estimated Expiration: ⤷ Try a Trial
Patent: 14054250
Estimated Expiration: ⤷ Try a Trial
Patent: 16104021
Estimated Expiration: ⤷ Try a Trial
Patent: 18027083
Estimated Expiration: ⤷ Try a Trial
Patent: 19062913
Estimated Expiration: ⤷ Try a Trial
Patent: 20072724
Estimated Expiration: ⤷ Try a Trial
Patent: 21072820
Estimated Expiration: ⤷ Try a Trial
Patent: 21072821
Estimated Expiration: ⤷ Try a Trial
Patent: 21072822
Estimated Expiration: ⤷ Try a Trial
Patent: 21104037
Estimated Expiration: ⤷ Try a Trial
Patent: 23036865
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 18211
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 12917
Estimated Expiration: ⤷ Try a Trial
Patent: 18211
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 18211
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 67664
Estimated Expiration: ⤷ Try a Trial
Patent: 13114396
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 01600111
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 649
Estimated Expiration: ⤷ Try a Trial
Patent: 361
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 12917
Estimated Expiration: ⤷ Try a Trial
Patent: 18211
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1310569
Estimated Expiration: ⤷ Try a Trial
Patent: 130069762
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 67411
Estimated Expiration: ⤷ Try a Trial
Patent: 50748
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 41024
Estimated Expiration: ⤷ Try a Trial
Patent: 1215408
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2012029986 | ⤷ Try a Trial | |
| Japan | 6867619 | ⤷ Try a Trial | |
| Japan | 2021072822 | アンチセンス核酸 (ANTISENSE NUCLEIC ACID) | ⤷ Try a Trial |
| Japan | 2014054250 | ANTISENSE NUCLEIC ACIDS | ⤷ Try a Trial |
| Taiwan | I541024 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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