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Last Updated: February 10, 2025

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
GlaxoSmithKlinePhase 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 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

Introduction to TEGSEDI

TEGSEDI (inotersen) is a groundbreaking drug developed by Ionis Pharmaceuticals, Inc. and Akcea Therapeutics, Inc. for the treatment of polyneuropathy of hereditary transthyretin amyloidosis (hATTR) in adult patients. Here, we delve into the market dynamics and financial trajectory of TEGSEDI.

Market Approval and Launch

TEGSEDI received significant regulatory approvals in 2018. In July 2018, it was granted marketing authorization by the European Commission for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis[4].

Market Size and Growth

The global transthyretin amyloidosis treatment market, which includes TEGSEDI, is expected to witness robust growth. In 2018, the market size was valued at US$ 35.8 million and is projected to grow at a CAGR of 55.4% over the forecast period (2018-2026)[4].

Revenue Contribution

TEGSEDI has been a significant contributor to the revenue of Ionis Pharmaceuticals and Akcea Therapeutics. For instance, in 2022, TEGSEDI and WAYLIVRA revenue, net of distribution fees, was $7 million for the third quarter and $30 million for the full year[2].

Distribution Channels

The distribution of TEGSEDI is primarily through hospital pharmacies, which is a segment projected to grow at the highest CAGR over the forecast period. This indicates a strong institutional demand for the drug[1].

Regional Performance

North America dominates the market for transthyretin amyloidosis treatments, including TEGSEDI, due to the increasing prevalence of amyloidosis among adults and the older population. The presence of pharmaceutical giants like Pfizer and Merck in this region also supports market growth[1].

Competitive Landscape

The market for transthyretin amyloidosis treatments is competitive, with several players including Alnylam Pharmaceuticals, Eidos Therapeutics, and Ionis Pharmaceuticals. TEGSEDI competes with other approved drugs such as ONPATTRO (patisiran) and tafamidis. Strategic partnerships, such as the one between Alnylam and Orsini Healthcare, are common in this market to enhance distribution and market share[4].

Financial Performance of Ionis Pharmaceuticals

Ionis Pharmaceuticals, the developer of TEGSEDI, has shown significant financial strength. In 2018, the company reported total revenue of $408 million for the year-to-date, with commercial revenue from TEGSEDI contributing to this figure. The company's cash position has been substantial, enabling continued investment in commercial products and pipeline development[3].

Revenue Breakdown

  • Commercial Revenue: TEGSEDI and WAYLIVRA revenue, net of distribution fees, has been a part of Ionis' commercial revenue, which was $303 million in 2022[2].
  • Research and Development Revenue: While TEGSEDI itself is a commercial product, the revenue from collaborative agreements and joint development projects also supports the overall financial health of Ionis[2].

Challenges: High Costs and Adoption

Despite its therapeutic benefits, TEGSEDI faces challenges related to its high cost. The annual cost of TEGSEDI is around $450,000 before insurance, which can hinder adoption even in developed economies. This high cost is a significant factor that could restrain market growth[4].

Pipeline and Future Growth

The robust pipeline of transthyretin amyloidosis treatment drugs, including those from Ionis and its partners, is expected to boost market growth. For example, AKCEA-TTR-LRx, co-developed by Ionis and Akcea Therapeutics, is in clinical development and aims to inhibit the production of transthyretin, offering potential future growth opportunities[4].

Key Takeaways

  • Market Growth: The global transthyretin amyloidosis treatment market, including TEGSEDI, is expected to grow significantly with a CAGR of 55.4% over the forecast period.
  • Revenue Contribution: TEGSEDI contributes substantially to Ionis Pharmaceuticals' commercial revenue.
  • Distribution: Hospital pharmacies are the primary distribution channels for TEGSEDI.
  • Regional Dominance: North America leads the market due to high prevalence and presence of pharmaceutical giants.
  • Competitive Landscape: TEGSEDI competes with other approved drugs, and strategic partnerships are crucial.
  • Financial Strength: Ionis Pharmaceuticals maintains a strong financial position, enabling continued investment in pipeline development.
  • Challenges: High costs of TEGSEDI can hinder adoption.

FAQs

What is TEGSEDI used for?

TEGSEDI (inotersen) is used for the treatment of polyneuropathy of hereditary transthyretin amyloidosis (hATTR) in adult patients.

When was TEGSEDI approved?

TEGSEDI was granted marketing authorization by the European Commission in July 2018 for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis[4].

How much does TEGSEDI cost?

The annual cost of TEGSEDI is around $450,000 before insurance[4].

Who are the key players in the transthyretin amyloidosis treatment market?

Key players include Ionis Pharmaceuticals, Akcea Therapeutics, Alnylam Pharmaceuticals, and Eidos Therapeutics[4].

What are the main distribution channels for TEGSEDI?

The main distribution channels for TEGSEDI are hospital pharmacies, which are projected to grow at the highest CAGR over the forecast period[1].

Cited Sources:

  1. Global Transthyretin Amyloidosis Treatment Market–Analysis - GlobeNewswire
  2. Ionis reports fourth quarter and full year 2022 financial results - PR Newswire
  3. Ionis Reports Third Quarter 2018 Financial Results - Ionis Pharmaceuticals
  4. Transthyretin Amyloidosis Treatment Market Size & Share Analysis - Coherent Market Insights

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