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Last Updated: April 15, 2024

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TEGSEDI Drug Patent Profile


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When do Tegsedi patents expire, and what generic alternatives are available?

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-three 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

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Summary for TEGSEDI
International Patents:33
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
Drug patent expirations by year for TEGSEDI
Drug Prices for TEGSEDI

See drug prices for TEGSEDI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TEGSEDI
Generic Entry Date for TEGSEDI*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Ionis Pharmaceuticals, Inc.Phase 3
Akcea TherapeuticsPhase 3
Ionis Pharmaceuticals, Inc.Phase 2/Phase 3

See all TEGSEDI clinical trials

US Patents and Regulatory Information for TEGSEDI

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEGSEDI is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Modulation of transthyretin expression
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Diagnosis and treatment of disease
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulation of transthyretin expression
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulation of transthyretin expression
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN AMYLOIDOSIS

FDA Regulatory Exclusivity protecting TEGSEDI

INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Exclusivity Expiration: ⤷  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
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 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

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

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

Patent: 2012027547
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 97792
Estimated Expiration: ⤷  Try a Trial

Patent: 94063
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3038345
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0170737
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 19070
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 63920
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 63920
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 31909
Estimated Expiration: ⤷  Try a Trial

Patent: 900001
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2697
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 96175
Estimated Expiration: ⤷  Try a Trial

Patent: 13526860
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 563920
Estimated Expiration: ⤷  Try a Trial

Patent: 2019001
Estimated Expiration: ⤷  Try a Trial

Patent: 63920
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 0096
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 3559
Estimated Expiration: ⤷  Try a Trial

Patent: 12012624
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 0963
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 3339
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 19001
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 63920
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 63920
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 92669
Estimated Expiration: ⤷  Try a Trial

Patent: 12150394
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 011
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 63920
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1835386
Estimated Expiration: ⤷  Try a Trial

Patent: 130098162
Estimated Expiration: ⤷  Try a Trial

Patent: 180026798
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 25689
Estimated Expiration: ⤷  Try a Trial

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
Australia 2003251387 ⤷  Try a Trial
Japan 2726754 ⤷  Try a Trial
Japan 2732544 ⤷  Try a Trial
Germany 69133180 ⤷  Try a Trial
Spain 2104717 ⤷  Try a Trial
Japan 2732546 ⤷  Try a Trial
Canada 2443641 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TEGSEDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2563920 2019001 Norway ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: INOTERSEEN;REG NO/DATE: EU/1/18/1296 10.07.2018
2563920 2019C/001 Belgium ⤷  Try a Trial PRODUCT NAME: UN OLIGONUCLEOTIDE MODIFIE AYANT UNE SEQUENCE CONSTITUEE DE NUCLEOSIDES RELIES TELLE QUE DEFINIE AU BREVET EP-B1-2563920, ET SPECIFIQUEMENT L'INOTERSEN; ET SES DERIVES, TELS QUE SES SELS, EN CE COMPRIS LES SELS SODIQUES; AUTHORISATION NUMBER AND DATE: EU/1/18/1296 20180710
2563920 CR 2019 00001 Denmark ⤷  Try a Trial PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
2563920 1/2019 Austria ⤷  Try a Trial PRODUCT NAME: INOTERSEN; REGISTRATION NO/DATE: EU/1/18/1296 (MITTEILUNG) 20180710
2563920 300963 Netherlands ⤷  Try a Trial PRODUCT NAME: INOTERSEN OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1296 20180710
2563920 122019000001 Germany ⤷  Try a Trial PRODUCT NAME: VERBINDUNG, UMFASSEND EIN MODIFIZIERTES OLIGONUKLEOTID MIT EINER NUKLEOBASENSEQUENZ BESTEHEND AUS 20 VERKNUEPFTEN NUKLEOSIDEN GEMAESS EP B1 2563920, ANSPRUCH 1 (SEQ ID NO: 80), WOBEI DAS MODIFIZIERTE OLIGONUKLEOTID UMFASST: EIN LUECKENSEGMENT, DAS AUS ZEHN VERKNUEPFTEN DESOXYNUKLEOSIDEN BESTEHT ; EIN 5'-FLUEGELSEGMENT BESTEHEND AUS FUENF VERKNUEPFTEN NUKLEOSIDEN; UND EIN 3'-FLUEGELSEGMENT BESTEHEND AUS FUEN; REGISTRATION NO/DATE: EU/1/18/1296 20180706
>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.