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Generated: November 14, 2018

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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 eight 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.
Summary for 209531
Tradename:SPINRAZA
Applicant:Biogen Idec
Ingredient:nusinersen sodium
Patents:8
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
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:RXDosage:SOLUTION;INTRATHECALStrength12MG/5ML (2.4MG/ML)
Approval Date:Dec 23, 2016TE: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 ➤ Sign Up ➤ Sign Up
Biogen Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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