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^: ➤ Sign Up* Constraining patent/regulatory exclusivity: ➤ Sign Up 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

Ingredient-type	Oligonucleotides, Antisense
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	12MG/5ML (2.4MG/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

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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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