Details for New Drug Application (NDA): 215887

NDA 215887 describes QALSODY, which is a drug marketed by Biogen Ma and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the QALSODY profile page.

The generic ingredient in QALSODY is tofersen. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tofersen profile page.

Summary for 215887

Tradename:	QALSODY
Applicant:	Biogen Ma
Ingredient:	tofersen
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 215887

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: 215887

Suppliers and Packaging for NDA: 215887

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
QALSODY	tofersen	SOLUTION;INTRATHECAL	215887	NDA	Biogen Inc.	64406-109	64406-109-01	1 VIAL, SINGLE-USE in 1 CARTON (64406-109-01) / 15 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRATHECAL			Strength	100MG/15ML (6.7MG/ML)
Approval Date:	Apr 25, 2023	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 25, 2028
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Apr 25, 2030
Regulatory Exclusivity Use:	TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE
Patent:		Patent Expiration:	Apr 1, 2035	Product Flag?	Y	Substance Flag?	Y	Delist Request?

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