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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
Summary for VILTEPSO
| International Patents: | 43 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| DailyMed Link: | VILTEPSO at DailyMed |
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 |
International Patents for VILTEPSO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hungary | E027321 | Start Trial |
| Croatia | P20160336 | Start Trial |
| Canada | 2809637 | Start Trial |
| European Patent Office | 2612917 | Start Trial |
| Japan | 2014054250 | Start Trial |
| Hungary | E046364 | Start Trial |
| Serbia | 54649 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
