QALSODY Drug Patent Profile

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 seventy-three patent family members in thirty 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 1, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for QALSODY

International Patents:	73
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for QALSODY
What excipients (inactive ingredients) are in QALSODY?	QALSODY excipients list
DailyMed Link:	QALSODY at DailyMed

See drug prices for QALSODY

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

Constraining patent/regulatory exclusivity:

10,385,341

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.

Recent Clinical Trials for QALSODY

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

Sponsor	Phase
Biogen	PHASE4

See all QALSODY clinical trials

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.

This potential generic entry date is based on patent 10,385,341.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	10,968,453
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	10,669,546

International Patents for QALSODY

When does loss-of-exclusivity occur for QALSODY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

France

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Netherlands

New Zealand

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Australia	2015240761
Australia	2019268063
Australia	2022200002

Supplementary Protection Certificates for QALSODY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3126499	CR 2024 00038	Denmark		PRODUCT NAME: TOFERSEN; REG. NO/DATE: EU/1/23/1783 20240603
3126499	301293	Netherlands		PRODUCT NAME: TOFERSEN; REGISTRATION NO/DATE: EU/1/23/1783 20240603
3126499	LUC00359	Luxembourg		PRODUCT NAME: TOFERSEN; AUTHORISATION NUMBER AND DATE: EU/1/23/1783 20240603

DrugChatter Q&A for QALSODY

Qalsody tofersen ema approval date?
Is Qalsody effective for SOD1-ALS?
What is the dosing for qalsody?
What are the side effects of Qalsody?