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.

Summary for 209531

Tradename:	SPINRAZA
Applicant:	Biogen Idec
Ingredient:	nusinersen sodium
Patents:	9

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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

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
Patent:	⤷ Sign Up	Patent Expiration:	Dec 5, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF SPINAL MUSCULAR ATROPHY
Patent:	⤷ Sign Up	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
Patent:	⤷ Sign Up	Patent Expiration:	Dec 5, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE

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
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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