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TEGSEDI Drug Patent Profile

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

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

See drug prices for TEGSEDI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TEGSEDI

NDA:

211172

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

See all TEGSEDI clinical trials

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.

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
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No			Y
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No				Y
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No			Y	Y

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
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018

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

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Korea

Spain

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
Germany	69232699
Russian Federation	2592669	МОДУЛЯЦИЯ ЭКСПРЕССИИ ТРАНСТИРЕТИНА (MODULATION OF EXPRESSION OF TRANSTHYRETIN)
Finland	951467
European Patent Office	0586570	ANALOGUES D'OLIGONUCLEOTIDES A SQUELETTE MODIFIE (BACKBONE MODIFIED OLIGONUCLEOTIDE ANALOGUES)

Supplementary Protection Certificates for TEGSEDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	LUC00096	Luxembourg		PRODUCT NAME: INOTERSEN AND SALTS THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1296 20180710
2563920	CR 2019 00001	Denmark		PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
2563920	PA2019001,C2563920	Lithuania		PRODUCT NAME: INOTERSENAS IR JO DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1296 20180706
2563920	CA 2019 00001	Denmark		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

TEGSEDI Market Analysis and Financial Projection Experimental

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