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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 215887


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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. 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
Generic Entry Date for 215887*:
Constraining patent/regulatory exclusivity:
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE
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.

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:RXDosage:SOLUTION;INTRATHECALStrength100MG/15ML (6.7MG/ML)
Approval Date:Apr 25, 2023TE: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:⤷  Sign UpPatent Expiration:Apr 1, 2035Product Flag?YSubstance Flag?YDelist Request?

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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.