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-five patent family members in twenty-five 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:	35
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

Constraining patent/regulatory exclusivity:

8,697,860

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
Akcea Therapeutics	Phase 3
Ionis Pharmaceuticals, Inc.	Phase 3
Ionis Pharmaceuticals, Inc.	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.

This potential generic entry date is based on patent 8,697,860.

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	9,399,774
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No	8,697,860		Y
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No	9,061,044			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	7,015,315
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018	8,101,743
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018	7,101,993

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

San Marino

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
Japan	3131222
South Korea	20180026798	트랜스티레틴 발현의 조절 (MODULATION OF TRANSTHYRETIN EXPRESSION)
European Patent Office	1461461

Supplementary Protection Certificates for TEGSEDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	132019000000004	Italy		PRODUCT NAME: INOTERSEN(TEGSEDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1296, 20180710
2563920	C201930001	Spain		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	1/2019	Austria		PRODUCT NAME: INOTERSEN; REGISTRATION NO/DATE: EU/1/18/1296 (MITTEILUNG) 20180710

Market Dynamics and Financial Trajectory for TEGSEDI (Inotersen)

Last updated: July 30, 2025

Executive Summary

TEGSEDI (inotersen) is a groundbreaking antisense oligonucleotide (ASO) developed by Ionis Pharmaceuticals, approved for the treatment of hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN). Since its FDA approval in 2018, TEGSEDI's market landscape has evolved amid the complex interplay of clinical efficacy, safety profile, pricing parameters, competitive elements, and regulatory developments. This article evaluates the key market forces and projective financial trajectories shaping TEGSEDI's trajectory, providing crucial insights for stakeholders.

Market Landscape and Therapeutic Context

Disease Area and Unmet Needs

Hereditary transthyretin amyloidosis (hATTR-A) is a progressive, rare, life-threatening disorder characterized by amyloid deposits formed from misfolded transthyretin proteins, leading to multi-organ failure, predominantly affecting the peripheral nerves and cardiac tissue. The disease's rarity contributes to significant unmet therapeutic needs for patients suffering from hATTR-PN, which manifests as sensory, motor, and autonomic nerve damage.

Therapeutic Options

Prior to TEGSEDI, treatment options were limited. Liver transplantation served as an option for select patients, but it was invasive and only offered temporary relief. The advent of disease-modifying therapies like TEGSEDI and Patisiran (another FDA-approved siRNA-based therapy) introduced pharmacological options targeting the underlying protein misfolding mechanisms. This evolving therapeutic landscape has introduced both competition and opportunities for market expansion.

Market Dynamics Influencing TEGSEDI

Regulatory Milestones and Expanding Approvals

Following FDA approval in late 2018, TEGSEDI received accelerated approval based on positive clinical data demonstrating significant reduction in TTR protein levels and symptom stabilization. Subsequent regulatory pathways in Europe, Japan, and other territories have expanded access, boosting global market potential. The recent inclusion of TEGSEDI in the UK’s NHS formulary and its coverage by various insurance payers heightens its commercial prospects.

Clinical and Safety Profile

TEGSEDI's utility hinges on its balance of efficacy and safety. Key clinical trials demonstrated a 52% reduction in serum TTR levels and stabilization of neurological function. However, the drug's safety profile, notably risks of thrombocytopenia and glomerulonephritis, warrants careful patient monitoring. These safety concerns influence physician prescribing patterns and reimbursement negotiations, impacting market penetration.

Pricing Strategy and Reimbursement Environment

TEGSEDI's cost is approximately $450,000 annually per patient, reflecting its specialized nature and manufacturing complexity. Reimbursement negotiations often involve health technology assessment bodies, such as NICE in the UK and IQWiG in Germany, which influence market access. Price sensitivity and the rarity of hATTR-PN favor value-based negotiations, although the high treatment cost constrains widespread adoption.

Competitive Dynamics

Patisiran (developed by Alnylam) offers an alternative, delivering similar efficacy but via siRNA technology with different administration routes. The choice between TEGSEDI and Patisiran is influenced by administration preferences, safety profiles, and regional approvals. Additionally, increasing interest in gene editing (e.g., CRISPR-based therapies) could disrupt current treatments, though these are still in early development stages.

Market Adoption Challenges

• Limited Patient Pool: As a rare disease, the global diagnosed population likely remains under 10,000 individuals, constraining revenue potential.
• Administration Logistics: TEGSEDI requires subcutaneous injections administered weekly or bi-weekly, which can impact patient compliance.
• Monitoring Requirements: Stringent safety monitoring adds logistical and economic burdens, possibly limiting use in resource-constrained settings.

Financial Trajectory and Revenue Projections

Current Revenue Profile

Since launch, TEGSEDI's revenues have grown modestly, with estimates placing US sales in the low hundreds of millions annually. Growth is primarily driven by increased diagnosis rates, expanded geographic access, and partnership agreements. However, rapid expansion faces barriers such as the small patient population and treatment costs.

Future Revenue Growth Drivers

• Market Expansion: Growing awareness and improved diagnostics could expand diagnosed cases by approximately 20-30% over the next five years.
• Line Extensions and Combination Therapies: Potential development of combination regimens or modified formulations may enhance efficacy and adherence.
• Global Access: Entry into emerging markets, facilitated by licensing and pricing agreements, can diversify revenue streams.
• Regulatory Approvals: New indications, such as transthyretin cardiomyopathy, could unlock additional market segments.

Potential Revenue Scenarios

• Best-Case: With broader acceptance, enhanced diagnosis, and expanded indications, TEGSEDI could reach peak year sales exceeding $1 billion globally within a decade, particularly if new formulations or delivery methods improve compliance.
• Moderate Scenario: Continued growth in existing indications, with stabilized market share, might yield annual revenues around $500-700 million.
• Downside Risks: Regulatory delays, safety concerns, or market competition could limit upside potential, keeping revenues below $300 million annually.

Cost Considerations and Margins

High manufacturing costs for ASO compounds and comprehensive monitoring requirements compress profit margins. However, locked-in manufacturing efficiencies and economies of scale in commercial production are expected to improve margins over time.

Strategic Considerations

• Pricing Negotiations: Engaging with payers to justify premium pricing through robust clinical data remains critical.
• Patient Monitoring and Safety Management: Developing standardized protocols to mitigate safety risks enhances confidence among clinicians and payers.
• Partnerships: Collaborations with global pharma and biotech ecosystems can accelerate market access, especially in emerging regions.
• Pipeline Development: Investing in next-generation antisense oligonucleotides and gene editing therapies positions the company for future market leadership.

Key Takeaways

• TEGSEDI holds a unique position as a first-in-class antisense therapy for hATTR-PN, with sustained clinical efficacy and safety profile regulation.
• Market penetration remains constrained by the rare nature of the disease, high costs, and safety monitoring needs, but expanding diagnosis rates and geographic access offer growth avenues.
• Competitive pressure from Patisiran and emerging gene therapies necessitates continuous innovation and strategic partnerships.
• Revenue projections suggest a trajectory toward $500 million to over $1 billion globally, contingent on expanded indications, accessibility, and optimized pricing.
• Monitoring regulatory developments, safety protocols, and payer negotiations remains essential to maximize TEGSEDI's commercial potential.

FAQs

1. What is the primary mechanism of action of TEGSEDI?
TEGSEDI employs antisense oligonucleotides to reduce the production of transthyretin protein in the liver, slowing amyloid deposition in target tissues.

2. How does TEGSEDI differ from Patisiran?
TEGSEDI is administered via subcutaneous injection and primarily reduces TTR levels directly, while Patisiran is delivered intravenously via siRNA technology with similar target effects but differing dosing schedules and safety profiles.

3. What are the main safety concerns associated with TEGSEDI?
Risks include thrombocytopenia and glomerulonephritis, requiring routine blood and renal function monitoring during treatment.

4. Which regions represent the most significant growth opportunities for TEGSEDI?
Europe, Japan, and emerging markets with improving healthcare infrastructure offer substantial expansion potential, especially as regulatory approvals become clearer.

5. How might gene therapy impact TEGSEDI’s market?
Gene editing therapies, such as CRISPR-based treatments, could provide curative options and potentially reduce reliance on transient therapies like TEGSEDI, influencing long-term market dynamics.

References

[1] FDA Drug Approval Package for TEGSEDI (2018).
[2] Ionis Pharmaceuticals Official Website. TEGSEDI Product Profile.
[3] European Medicines Agency (EMA). TEGSEDI Approval Details.
[4] GlobalData. Hereditary Transthyretin Amyloidosis Market Analysis.
[5] NICE Guidance on Hereditary Transthyretin Amyloidosis Treatments.