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tegsedi Drug Patent Profile

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

Tegsedi is a drug marketed by Akcea Theraps and is included in one NDA. There are four patents protecting this drug.

This drug has thirty-four patent family members in twenty-four countries.

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

DrugPatentWatch^® Generic Entry Outlook for Tegsedi

Tegsedi was eligible for patent challenges on October 5, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 29, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for tegsedi

International Patents:	34
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for tegsedi
What excipients (inactive ingredients) are in tegsedi?	tegsedi excipients list
DailyMed Link:	tegsedi at DailyMed

See drug prices for tegsedi

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

NDA:

211172

Dosage:

SOLUTION;SUBCUTANEOUS

^*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 tegsedi

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

Sponsor	Phase
Ionis Pharmaceuticals, Inc.	Phase 3
Akcea Therapeutics	Phase 3
Ionis Pharmaceuticals, Inc.	Phase 2/Phase 3

See all tegsedi clinical trials

Pharmacology for tegsedi

Drug Class	Antisense Oligonucleotide Transthyretin-directed RNA Interaction
Physiological Effect	Decreased RNA Integrity Increased Protein Breakdown

US Patents and Regulatory Information for tegsedi

tegsedi is protected by four US patents and one FDA Regulatory Exclusivity.

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 tegsedi

FDA Regulatory Exclusivity protecting tegsedi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No			Y
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No				Y
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No			Y	Y
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No

Expired US Patents for tegsedi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018

International Patents for tegsedi

When does loss-of-exclusivity occur for tegsedi?

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

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

Russian Federation

Serbia

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 tegsedi around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1004593
Finland	923707
Japan	2739769
European Patent Office	1036165
Australia	5167393

Supplementary Protection Certificates for tegsedi

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	CR 2019 00001	Denmark		PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
2563920	2019001	Norway		PRODUCT NAME: FORBINDELSE OMFATTENDE ET MODIFISERT OLIGONUKLEOTID SOM HAR EN NUKLEOBASESEKVENS BESTAENDE AV 20 KOBLEDE NUKLEOSIDER IFOELGE EP B1 2563920 KRAV 1 (SEQ ID NO: 80), HVOR DET MODIFISERTE OLIGONUKLEOTIDET OMFATTER: ET AVSTANDSSEGMENT BESTAENDE AV TI KOBLEDE DEOKSYNUKLEOSIDER; ET 5'- VINGESEGMENT BESTAENDE AV FEM KOBLEDE NUKLEOSIDER; OG ET 3'-VINGESEGMENT BESTAENDE AV FEM KOBLEDE NUKLEOSIDER; HVOR AVSTANDSSEGMENTET ER PLASSERT MELLOM 5'- VINGESEGMENTET OG 3'- VINGESEGMENTET, HVOR HVERT NUKLEOSID AV HVERT VINGESEGMENT OMFATTER ET 2'- 0-METOKSYETYLSUKKER; HVOR HVER CYTOSIN AV DET MODIFISERTE OLIGONUKLEOTID ER EN 5-METYLCYTOSIN, OG HVOR HVER INTERNUKLEOSID-BINDING AV DET MODIFISERTE OL
2563920	C20190002 00303	Estonia		PRODUCT NAME: INOTERSEEN;REG NO/DATE: EU/1/18/1296 10.07.2018
2563920	19C1000	France		PRODUCT NAME: INOTERSEN ET SES SELS; REGISTRATION NO/DATE: EU/1/18/1296 20180710
2563920	300963	Netherlands		PRODUCT NAME: INOTERSEN OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1296 20180710