Details for New Drug Application (NDA): 209531
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The generic ingredient in SPINRAZA is nusinersen sodium. One supplier is listed for this compound. Additional details are available on the nusinersen sodium profile page.
Summary for 209531
Tradename: | SPINRAZA |
Applicant: | Biogen Idec |
Ingredient: | nusinersen sodium |
Patents: | 9 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 209531
Generic Entry Date for 209531*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRATHECAL |
*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.
Pharmacology for NDA: 209531
Physiological Effect | Increased Protein Synthesis |
Suppliers and Packaging for NDA: 209531
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531 | NDA | Biogen | 64406-058 | 64406-058-01 | 1 VIAL, SINGLE-USE in 1 BOX (64406-058-01) / 5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRATHECAL | Strength | EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) | ||||
Approval Date: | Dec 23, 2016 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Dec 23, 2023 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF SPINAL MUSCULAR ATROPHY IN PEDIATRIC AND ADULT PATIENTS | ||||||||
Patent: | See Plans and Pricing | Patent Expiration: | Dec 5, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF SPINAL MUSCULAR ATROPHY | ||||||||
Patent: | See Plans and Pricing | Patent Expiration: | Dec 5, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA |
Expired US Patents for NDA 209531
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | See Plans and Pricing | See Plans and Pricing |
Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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