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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for TEGSEDI?
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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 |


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
Sponsor | Phase |
---|---|
Ionis Pharmaceuticals, Inc. | Phase 3 |
Akcea Therapeutics | Phase 3 |
GlaxoSmithKline | Phase 2/Phase 3 |
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEGSEDI is ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>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 for Free | ⤷ Try for Free |
Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | ⤷ Try for Free | ⤷ Try for Free |
>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
Patent: composto compreendendo oligonucleotídeo, composição, e seus usos para prevenir tratar, melhorar ou retardar a progressão da amiloidose transtirretina ou para reduzir a expressão de mrna ou de proteína de transtirretina
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 97792
Patent: MODULATION DE L'EXPRESSION DE LA TRANSTHYRETINE (MODULATION OF TRANSTHYRETIN EXPRESSION)
Estimated Expiration: ⤷ Try for Free
Patent: 94063
Patent: MODULATION DE L'EXPRESSION DE LA TRANSTHYRETINE (MODULATION OF TRANSTHYRETIN EXPRESSION)
Estimated Expiration: ⤷ Try for Free
China
Patent: 3038345
Patent: Modulation of transthyretin expression
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0170737
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 19070
Estimated Expiration: ⤷ Try for Free
Patent: 19001
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 63920
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 63920
Patent: MODULATION DE L'EXPRESSION DE LA TRANSTHYRÉTINE (MODULATION OF TRANSTHYRETIN EXPRESSION)
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 31909
Estimated Expiration: ⤷ Try for Free
Patent: 900001
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 2697
Patent: איפנון הביטוי של טרנסתירטין (Modulation of transthyretin expression)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 96175
Estimated Expiration: ⤷ Try for Free
Patent: 13526860
Estimated Expiration: ⤷ Try for Free
Lithuania
Patent: 563920
Estimated Expiration: ⤷ Try for Free
Patent: 2019001
Estimated Expiration: ⤷ Try for Free
Patent: 63920
Estimated Expiration: ⤷ Try for Free
Luxembourg
Patent: 0096
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 3559
Patent: MODULACION DE LA EXPRESION DE TRANSTIRETINA. (MODULATION OF TRANSTHYRETIN EXPRESSION.)
Estimated Expiration: ⤷ Try for Free
Patent: 12012624
Patent: MODULACION DE LA EXPRESION DE TRANSTIRETINA. (MODULATION OF TRANSTHYRETIN EXPRESSION.)
Estimated Expiration: ⤷ Try for Free
Netherlands
Patent: 0963
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 3339
Patent: Modulation of transthyretin expression
Estimated Expiration: ⤷ Try for Free
Norway
Patent: 19001
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 63920
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 63920
Estimated Expiration: ⤷ Try for Free
Russian Federation
Patent: 92669
Patent: МОДУЛЯЦИЯ ЭКСПРЕССИИ ТРАНСТИРЕТИНА (MODULATION OF EXPRESSION OF TRANSTHYRETIN)
Estimated Expiration: ⤷ Try for Free
Patent: 12150394
Patent: МОДУЛЯЦИЯ ЭКСПРЕССИИ ТРАНСТИРЕТИНА
Estimated Expiration: ⤷ Try for Free
Serbia
Patent: 011
Patent: MODULACIJA EKSPRESIJE TRANSTIRETINA (MODULATION OF TRANSTHYRETIN EXPRESSION)
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 63920
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 1835386
Estimated Expiration: ⤷ Try for Free
Patent: 130098162
Patent: MODULATION OF TRANSTHYRETIN EXPRESSION
Estimated Expiration: ⤷ Try for Free
Patent: 180026798
Patent: 트랜스티레틴 발현의 조절 (MODULATION OF TRANSTHYRETIN EXPRESSION)
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 25689
Estimated Expiration: ⤷ Try for Free
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 | 4371296 | ⤷ Try for Free | |
Japan | 2635216 | ⤷ Try for Free | |
European Patent Office | 0586570 | ANALOGUES D'OLIGONUCLEOTIDES A SQUELETTE MODIFIE (BACKBONE MODIFIED OLIGONUCLEOTIDE ANALOGUES) | ⤷ Try for Free |
Australia | 4684099 | ⤷ Try for Free | |
Canada | 2491497 | ⤷ Try for Free | |
Austria | 294811 | ⤷ Try for Free | |
Australia | 4570699 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEGSEDI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2563920 | PA2019001,C2563920 | Lithuania | ⤷ Try for Free | PRODUCT NAME: INOTERSENAS IR JO DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1296 20180706 |
2563920 | 2019C/001 | Belgium | ⤷ Try for Free | 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 | 300963 | Netherlands | ⤷ Try for Free | PRODUCT NAME: INOTERSEN OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1296 20180710 |
2563920 | C201930001 | Spain | ⤷ Try for Free | 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 | 687 | Finland | ⤷ Try for Free | |
2563920 | 1990001-8 | Sweden | ⤷ Try for Free | PRODUCT NAME: INOTERSEN AND SALTS THEREOF; REG. NO/DATE: EU/1/18/1296 20180710 |
2563920 | 132019000000004 | Italy | ⤷ Try for Free | PRODUCT NAME: INOTERSEN(TEGSEDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1296, 20180710 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
TEGSEDI: Market Dynamics and Financial Trajectory
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