Details for New Drug Application (NDA): 212154
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NDA 212154 describes VILTEPSO, which is a drug marketed by Nippon Shinyaku and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VILTEPSO profile page.
The generic ingredient in VILTEPSO is viltolarsen. One supplier is listed for this compound. Additional details are available on the viltolarsen profile page.
The generic ingredient in VILTEPSO is viltolarsen. One supplier is listed for this compound. Additional details are available on the viltolarsen profile page.
Summary for 212154
| Tradename: | VILTEPSO |
| Applicant: | Nippon Shinyaku |
| Ingredient: | viltolarsen |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212154
Generic Entry Date for 212154*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 212154
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VILTEPSO | viltolarsen | SOLUTION;INTRAVENOUS | 212154 | NDA | NS Pharma, Inc. | 73292-011 | 73292-011-01 | 1 VIAL, GLASS in 1 CARTON (73292-011-01) / 1 INJECTION, SOLUTION in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 250MG/5ML (50MG/ML) | ||||
| Approval Date: | Aug 12, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 12, 2027 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Regulatory Exclusivity Expiration: | Aug 12, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,870,676 | Patent Expiration: | Aug 31, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| 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 | ||||||||
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