~ Buy the QALSODY (tofersen) Drug Profile, 2024 PDF Report in the Report Store ~

QALSODY Drug Patent Profile

✉ Email this page to a colleague

When do Qalsody patents expire, and when can generic versions of Qalsody launch?

Qalsody is a drug marketed by Biogen Ma and is included in one NDA. There are three patents protecting this drug.

This drug has sixty patent family members in twenty-six countries.

The generic ingredient in QALSODY is tofersen. One supplier is listed for this compound. Additional details are available on the tofersen profile page.

DrugPatentWatch^® Generic Entry Outlook for Qalsody

Qalsody will be eligible for patent challenges on April 25, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 25, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for QALSODY?
What are the global sales for QALSODY?
What is Average Wholesale Price for QALSODY?

Summary for QALSODY

International Patents:	60
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for QALSODY
What excipients (inactive ingredients) are in QALSODY?	QALSODY excipients list
DailyMed Link:	QALSODY at DailyMed

Drug patent expirations by year for QALSODY

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

Generic Entry Date for QALSODY^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE NDA: 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 QALSODY

Drug Class	Antisense Oligonucleotide

US Patents and Regulatory Information for QALSODY

QALSODY is protected by three US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QALSODY is ⤷ Sign Up.

This potential generic entry date is based on TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting QALSODY

Compositions for modulating SOD-1 expression
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Compositions for modulating SOD-1 expression
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE

FDA Regulatory Exclusivity protecting QALSODY

TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE
Exclusivity Expiration: ⤷ Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for QALSODY

See the table below for patents covering QALSODY around the world.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Canada	2942394		⤷ Sign Up
Japan	2019201664		⤷ Sign Up
Chile	2019002535	Composiciones para modular la expresión de sod-1.(divisional solicitud 201801897).	⤷ Sign Up
South Korea	20240111010	SOD-1 발현을 조절하기 위한 조성물 (SOD-1 COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)	⤷ Sign Up
Japan	2024105714	ＳＯＤ－１発現を調節するための組成物	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for QALSODY

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3126499	301293	Netherlands	⤷ Sign Up	PRODUCT NAME: TOFERSEN; REGISTRATION NO/DATE: EU/1/23/1783 20240603
3126499	CR 2024 00038	Denmark	⤷ Sign Up	PRODUCT NAME: TOFERSEN; REG. NO/DATE: EU/1/23/1783 20240603
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description