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Details for New Drug Application (NDA): 209531
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NDA 209531 describes SPINRAZA, which is a drug marketed by Biogen Idec and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the SPINRAZA profile page.
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.
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 |
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: | May 14, 2021 | ||||||||
| Regulatory Exclusivity Use: | CHANGES TO THE LABELING BASED ON RESULTS FROM A CONTROLLED CLINICAL TRIAL IN PATIENTS WITH LATER-ONSET SPINAL MUSCULAR ATROPHY | ||||||||
| Regulatory Exclusivity Expiration: | Dec 23, 2021 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Dec 23, 2023 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF SPINAL MUSCULAR ATROPHY IN PEDIATRIC AND ADULT PATIENTS | ||||||||
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 | Start Trial | Start Trial |
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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