TOFERSEN - Generic Drug Details

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What are the generic sources for tofersen and what is the scope of patent protection?

Tofersen is the generic ingredient in one branded drug marketed by Biogen Ma and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tofersen has sixty patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for TOFERSEN

International Patents:	60
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
What excipients (inactive ingredients) are in TOFERSEN?	TOFERSEN excipients list
DailyMed Link:	TOFERSEN at DailyMed

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

Generic Entry Date for TOFERSEN^: ⤷ 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 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.

Recent Clinical Trials for TOFERSEN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Biogen	Phase 3
Ionis Pharmaceuticals, Inc.	Phase 3

See all TOFERSEN clinical trials

Pharmacology for TOFERSEN

Drug Class	Antisense Oligonucleotide

Anatomical Therapeutic Chemical (ATC) Classes for TOFERSEN

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

US Patents and Regulatory Information for TOFERSEN

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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	⤷ 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
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 TOFERSEN

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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 TOFERSEN

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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

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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.