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QALSODY Drug Patent Profile

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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 fifty-six patent family members in twenty-five 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

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Summary for QALSODY

International Patents:	56
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^: ⤷ Try a Trial* 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.

Anatomical Therapeutic Chemical (ATC) Classes for QALSODY

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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 ⤷ Try a Trial.

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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Compositions for modulating SOD-1 expression
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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.

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Country	Patent Number	Title	Estimated Expiration
Singapore	11201608109T	COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION	⤷ Try a Trial
Malaysia	192634	COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2015153800		⤷ Try a Trial
Denmark	3126499		⤷ Try a Trial
Japan	2023027299	ＳＯＤ－１発現を調節するための組成物	⤷ Try a Trial
Serbia	63487	KOMPOZICIJE ZA MODULACIJU EKSPRESIJE SOD-1 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration