Details for New Drug Application (NDA): 212154
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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: | ⤷ Sign Up | 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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