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Last Updated: May 23, 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-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

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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
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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Diagnosis and treatment of disease
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modulation of transthyretin expression
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modulation of transthyretin expression
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Akcea Theraps TEGSEDI inotersen sodium SOLUTION;SUBCUTANEOUS 211172-001 Oct 5, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  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 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: ⤷  Sign Up

Canada

Patent: 97792
Estimated Expiration: ⤷  Sign Up

Patent: 94063
Estimated Expiration: ⤷  Sign Up

China

Patent: 3038345
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0170737
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 19070
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 63920
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 63920
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 31909
Estimated Expiration: ⤷  Sign Up

Patent: 900001
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 2697
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 96175
Estimated Expiration: ⤷  Sign Up

Patent: 13526860
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 563920
Estimated Expiration: ⤷  Sign Up

Patent: 2019001
Estimated Expiration: ⤷  Sign Up

Patent: 63920
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 0096
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 3559
Estimated Expiration: ⤷  Sign Up

Patent: 12012624
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 0963
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 3339
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 19001
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 63920
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 63920
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 92669
Estimated Expiration: ⤷  Sign Up

Patent: 12150394
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 011
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 63920
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1835386
Estimated Expiration: ⤷  Sign Up

Patent: 130098162
Estimated Expiration: ⤷  Sign Up

Patent: 180026798
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 25689
Estimated Expiration: ⤷  Sign Up

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 5788599 ⤷  Sign Up
Australia 2003243472 ⤷  Sign Up
Australia 762212 ⤷  Sign Up
Australia 673193 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TEGSEDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2563920 132019000000004 Italy ⤷  Sign Up PRODUCT NAME: INOTERSEN(TEGSEDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1296, 20180710
2563920 LUC00096 Luxembourg ⤷  Sign Up PRODUCT NAME: INOTERSEN AND SALTS THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1296 20180710
2563920 354 1-2019 Slovakia ⤷  Sign Up PRODUCT NAME: INOTERSEN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1296 20180710
2563920 PA2019001,C2563920 Lithuania ⤷  Sign Up PRODUCT NAME: INOTERSENAS IR JO DRUSKOS; 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.