Details for New Drug Application (NDA): 209531
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NDA 209531 describes SPINRAZA, which is a drug marketed by Biogen and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the SPINRAZA profile page.
The generic ingredient in SPINRAZA is nusinersen sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nusinersen sodium profile page.
The generic ingredient in SPINRAZA is nusinersen sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nusinersen sodium profile page.
Summary for 209531
| Tradename: | SPINRAZA |
| Applicant: | Biogen |
| Ingredient: | nusinersen sodium |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209531
Generic Entry Date for 209531*:
Constraining patent/regulatory exclusivity:
NEW STRENGTH 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 Inc. | 64406-036 | 64406-036-01 | 1 VIAL, SINGLE-USE in 1 BOX (64406-036-01) / 5 mL in 1 VIAL, SINGLE-USE |
| SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531 | NDA | Biogen Inc. | 64406-037 | 64406-037-01 | 1 VIAL, SINGLE-USE in 1 BOX (64406-037-01) / 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 | |||||
| Patent: | 10,436,802 | Patent Expiration: | Sep 11, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY | ||||||||
| Patent: | 10,436,802 | Patent Expiration: | Sep 11, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SPINAL MUSCULAR ATROPHY | ||||||||
| Patent: | 10,436,802 | Patent Expiration: | Sep 11, 2035 | 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 | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | 10,266,822 | ⤷ Start Trial |
| Biogen | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | 7,101,993 | ⤷ Start Trial |
| Biogen | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | 6,210,892 | ⤷ Start Trial |
| Biogen | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | 8,110,560 | ⤷ Start Trial |
| Biogen | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | 6,166,197 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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