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Last Updated: March 20, 2023

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 six patents protecting this drug.

This drug has five hundred and thirty-two patent family members in thirty 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:532
US Patents:6
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 Generic Entry Opportunity 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
Akcea TherapeuticsPhase 3
Ionis Pharmaceuticals, Inc.Phase 3
GlaxoSmithKlinePhase 2/Phase 3

See all TEGSEDI clinical trials

US Patents and Regulatory Information for TEGSEDI

TEGSEDI is protected by six US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEGSEDI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Gapped oligonucleotides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Oligonucleotides containing 2'-O-modified purines
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modulation of transthyretin expression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Diagnosis and treatment of disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modulation of transthyretin expression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modulation of transthyretin expression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN AMYLOIDOSIS

FDA Regulatory Exclusivity protecting TEGSEDI

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 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: See Plans and Pricing

Canada

Patent: 97792
Estimated Expiration: See Plans and Pricing

Patent: 94063
Estimated Expiration: See Plans and Pricing

China

Patent: 3038345
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0170737
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19070
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 63920
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 63920
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 31909
Estimated Expiration: See Plans and Pricing

Patent: 900001
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2697
Estimated Expiration: See Plans and Pricing

Japan

Patent: 96175
Estimated Expiration: See Plans and Pricing

Patent: 13526860
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 563920
Estimated Expiration: See Plans and Pricing

Patent: 2019001
Estimated Expiration: See Plans and Pricing

Patent: 63920
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0096
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 3559
Estimated Expiration: See Plans and Pricing

Patent: 12012624
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0963
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3339
Estimated Expiration: See Plans and Pricing

Norway

Patent: 19001
Estimated Expiration: See Plans and Pricing

Poland

Patent: 63920
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 63920
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 92669
Estimated Expiration: See Plans and Pricing

Patent: 12150394
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 011
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 63920
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1835386
Estimated Expiration: See Plans and Pricing

Patent: 130098162
Estimated Expiration: See Plans and Pricing

Patent: 180026798
Estimated Expiration: See Plans and Pricing

Spain

Patent: 25689
Estimated Expiration: See Plans and Pricing

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 1390536 See Plans and Pricing
European Patent Office 0728139 NUCLEOSIDES ET OLIGONUCLEOSIDES A FONCTION(S) AMINE (AMINE-DERIVATIZED NUCLEOSIDES AND OLIGONUCLEOSIDES) See Plans and Pricing
European Patent Office 1448585 See Plans and Pricing
European Patent Office 0692930 See Plans and Pricing
Japan 3349501 See Plans and Pricing
European Patent Office 0714449 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TEGSEDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2563920 1990001-8 Sweden See Plans and Pricing PRODUCT NAME: INOTERSEN AND SALTS THEREOF; REG. NO/DATE: EU/1/18/1296 20180710
2563920 C201930001 Spain See Plans and Pricing PRODUCT NAME: INOTERSEN Y SUS SALES FARMACEUTICAMENTE ACEPTABLES, EN PARTICULAR LA SAL SODICA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1296; DATE OF AUTHORISATION: 20180706; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1296; DATE OF FIRST AUTHORISATION IN EEA: 20180706
2563920 132019000000004 Italy See Plans and Pricing PRODUCT NAME: INOTERSEN(TEGSEDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1296, 20180710
2563920 354 1-2019 Slovakia See Plans and Pricing PRODUCT NAME: INOTERSEN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1296 20180710
2563920 CA 2019 00001 Denmark See Plans and Pricing PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710
2563920 19C1000 France See Plans and Pricing PRODUCT NAME: INOTERSEN ET SES SELS; REGISTRATION NO/DATE: EU/1/18/1296 20180710
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
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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.