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 Generic Entry Opportunity Date for 209531

Generic Entry Date for 209531^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing 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:	Dec 23, 2023
Regulatory Exclusivity Use:	TREATMENT OF SPINAL MUSCULAR ATROPHY IN PEDIATRIC AND ADULT PATIENTS
Patent:	See Plans and Pricing	Patent Expiration:	Dec 5, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF SPINAL MUSCULAR ATROPHY
Patent:	See Plans and Pricing	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

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	See Plans and Pricing	See Plans and Pricing
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.