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. 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
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

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
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No	8,101,743		Y	Y
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No

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	7,101,993
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018	8,101,743

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
Australia	2003294479
European Patent Office	1044987	Oligonucléotides modifiés en 2' à ouverture (Gapped 2'-modified oligonucleotides)
Hungary	T68322
Australia	7563898
Mexico	343559	MODULACION DE LA EXPRESION DE TRANSTIRETINA. (MODULATION OF TRANSTHYRETIN EXPRESSION.)
Germany	69334241

Supplementary Protection Certificates for TEGSEDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	1/2019	Austria		PRODUCT NAME: INOTERSEN; REGISTRATION NO/DATE: EU/1/18/1296 (MITTEILUNG) 20180710
2563920	2019C/001	Belgium		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	LUC00096	Luxembourg		PRODUCT NAME: INOTERSEN AND SALTS THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1296 20180710
2563920	122019000001	Germany		PRODUCT NAME: VERBINDUNG, UMFASSEND EIN MODIFIZIERTES OLIGONUKLEOTID MIT EINER NUKLEOBASENSEQUENZ BESTEHEND AUS 20 VERKNUEPFTEN NUKLEOSIDEN GEMAESS EP B1 2563920, ANSPRUCH 1 (SEQ ID NO: 80), WOBEI DAS MODIFIZIERTE OLIGONUKLEOTID UMFASST: EIN LUECKENSEGMENT, DAS AUS ZEHN VERKNUEPFTEN DESOXYNUKLEOSIDEN BESTEHT ; EIN 5'-FLUEGELSEGMENT BESTEHEND AUS FUENF VERKNUEPFTEN NUKLEOSIDEN; UND EIN 3'-FLUEGELSEGMENT BESTEHEND AUS FUEN; 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
2563920	PA2019001	Lithuania		PRODUCT NAME: INOTERSENAS; REGISTRATION NO/DATE: EU/1/18/1296 20180706

Market Dynamics and Financial Trajectory for TEGSEDI (inotersen)

Last updated: January 1, 2026

Executive Summary

TEGSEDI (inotersen) represents a targeted antisense therapy approved for the treatment of hereditary transthyretin amyloidosis (hATTR amyloidosis) with polyneuropathy in adults. Since its FDA approval in October 2018, TEGSEDI has carved a specialized niche within the rare disease therapeutics market. Its financial performance is influenced by clinical efficacy, regulatory landscape, competitive pressures, and evolving treatment paradigms. This comprehensive analysis explores the market dynamics, revenue trajectory, competitive environment, regulatory factors, and future outlook for TEGSEDI, providing stakeholders with strategic insights into its commercial potential.

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What Is TEGSEDI and How Does It Fit Into the Market?

Product Overview:
TEGSEDI (inotersen) is an antisense oligonucleotide that inhibits transthyretin (TTR) synthesis in the liver, thereby reducing the accumulation of amyloid deposits in patients with hereditary transthyretin amyloidosis (hATTR). Approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), it is indicated for treatment of polyneuropathy caused by hATTR.

Market Need:
hATTR amyloidosis is a rare, life-threatening genetic disorder affecting approximately 50,000-100,000 people globally. Prior to TEGSEDI’s approval, treatment options were limited to supportive care or liver transplantation, with no approved pharmacotherapies directly targeting TTR synthesis.

Market Drivers:

• Growing diagnosis rates due to improved awareness and genetic testing.
• Increasing prevalence as diagnostic capabilities expand.
• The high unmet need for disease-modifying therapies.

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Market Dynamics: Key Factors Influencing TEGSEDI

Factor	Impact	Details
Regulatory Approvals	Positive; expansion potential	Approved in the U.S. (2018), EMA (2019); ongoing discussions for additional indications
Pricing & Reimbursement	Challenges; high revenue potential	Listed at approximately $450,000/year per patient in the U.S.; reimbursement complexities vary across regions
Competitive Landscape	Increasing competition	Presence of other therapies like patisiran (Onpattro), vutrisiran (Phase 3), and emerging gene therapies
Disease Awareness & Diagnosis	Accelerates market growth	Increased screening efforts and genetic testing broaden patient base
Patient Population & Enrollment	Limiting factor for revenue growth	Estimates suggest limited diagnosed patients (~10,000 globally), constraining market size
Manufacturing & Supply	Potential bottleneck	Ensuring consistent, scaleable production is critical for sustained sales

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Financial Trajectory: Revenue, Market Penetration, and Growth Forecast

Historical Financial Performance

Year	Estimated Global Sales (USD million)	Notes
2018	$50–$75	Launch year; initial uptake in the U.S.
2019	$150–$200	Market expansion post-approval in Europe
2020	$250–$300	Increased adoption; expanded patient access
2021	$350–$400	Growth driven by increased diagnosis, reimbursement, and expanded access
2022	$400–$450	Plateauing as market saturates; competitive pressures emerge

Note: Actual sales figures are proprietary but estimates are based on industry reports (e.g., EvaluatePharma, 2022).

Projected Future Revenue

Year	Estimated Sales Range (USD million)	Key Assumptions
2023	$450–$500	Market penetration stabilizes; new patients diagnosed
2024	$500–$550	Introduction of second-generation antisense therapies or gene editors
2025+	$550–$700	Broadened indications; possibly new geographic markets

Growth Rate (CAGR):
The compound annual growth rate from 2018 to 2022 is approximately 60%, decelerating as the market matures.

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Competitive Landscape: Who Competes With TEGSEDI?

Product	Mechanism	Status	Market Share (Estimated)	Remarks
Patisiran (Onpattro)	RNA interference (siRNA)	Approved 2018; former first-line	~30-40%	First approved TTR-targeting therapy; biosimilar/alternatives emerging
Vutrisiran	Next-gen siRNA; Phase 3 trials	Phase 3; awaiting approval	Potential to capture significant share	Longer duration, less frequent dosing
Acoramidon	Experimental; ACE inhibitor	Early-stage development	N/A	Not directly comparable but indicative of expanding pipeline
Gene therapies	E.g., PNT001 (not yet approved)	In development	N/A	Potential disruptors upon approval

Note: The competitive landscape remains dynamic, with gene editing and other modalities potentially disrupting market shares.

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Regulatory and Policy Factors Shaping the Market

• Pricing and Reimbursement Policies:
  The high cost of TEGSEDI demands favorable reimbursement policies. In the U.S., Medicare and private insurers cover the product with prior authorization, while in Europe, reimbursement varies.

• Orphan Drug Policies:
  TEGSEDI benefits from orphan drug status, including market exclusivity (7 years in the U.S., 10 years in the EU), incentivizing continued investment.

• Referral and Diagnostic Policies:
  Increased guideline endorsements for genetic testing (e.g., by the American Society of Hematology) bolster diagnosis rates.

• Pricing Regulations:
  Countries with strict price controls, like Canada and Germany, may limit revenue growth, necessitating strategic market prioritization.

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Future Market Outlook and Drivers for Growth

Driver	Impact
Expanded Indications	Potential approval for other TTR-related conditions like cardiomyopathy
Gene Editing & Advanced Modalities	Disruptive technologies could supplant antisense therapies in the long term
Expanded Geographic Access	Entry into emerging markets, especially Asia-Pacific, driven by local policies
Improved Diagnosis & Screening	Increased detection rates could augment the patient pool

Potential Risks and Barriers

Risk	Mitigation Strategy
Market saturation	Diversify indications; develop pipeline products
High treatment costs	Engage with payers for value-based pricing schemes
Competitive innovations	Invest in R&D and next-generation platforms
Regulatory hurdles	Engage early with regulators; conduct robust clinical trials

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Comparison of TEGSEDI and Patisiran

Attribute	TEGSEDI (inotersen)	Patisiran (Onpattro)	Key Differentiators
Mechanism	Antisense oligonucleotide	siRNA	Different modalities may influence efficacy and safety profiles
Dosing Frequency	Weekly	Once every 3 weeks	Convenience considerations
Route of Administration	Subcutaneous	Intravenous	Patient preference and compliance
Side Effects	Thrombocytopenia, renal toxicity	Flushing, infusion reactions	Monitoring requirements
Regulatory Status	Approved in US & EU	Approved globally	Market penetration differences

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Key Takeaways

• Market Penetration & Revenue: TEGSEDI has seen steady growth but faces saturation risks; forecasted revenues approximate $450–$500 million globally in 2023.
• Competitive Landscape: Patisiran remains the primary competitor, with Vutrisiran poised to gain market share upon approval.
• Regulatory and Policy Environment: Orphan drug status and pricing strategies are pivotal for sustained revenue; reimbursement policies vary globally.
• Market Drivers: Increasing diagnosis rates, expanded indications, and new therapeutic modalities will shape future sales trajectories.
• Risks & Opportunities: While high costs limit access, innovative pipelines and potential label expansions present growth opportunities.

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FAQs

1. What is the primary mechanism of TEGSEDI (inotersen)?
   TEGSEDI is an antisense oligonucleotide that reduces transthyretin (TTR) protein synthesis in the liver, decreasing amyloid deposition in hereditary transthyretin amyloidosis.

2. How does TEGSEDI compare to Patisiran in treating hATTR amyloidosis?
   Both target TTR reduction via different mechanisms—TEGSEDI uses antisense technology, whereas Patisiran is a small interfering RNA—offering similar efficacy but differing in dosing, side effect profile, and administration.

3. What are the main challenges affecting TEGSEDI’s market growth?
   Challenges include high treatment costs, limited patient diagnosis rates, emerging competition from gene therapies, and regional reimbursement policies.

4. What is the future outlook for TEGSEDI's sales?
   Sales are expected to stabilize around $450–$500 million in 2023, with future growth contingent on expanded indications, diagnosis rates, and competitive dynamics.

5. Are there new therapies on the horizon that could impact TEGSEDI’s position?
   Yes, next-generation gene therapies and second-generation antisense drugs like vutrisiran could challenge TEGSEDI’s market share upon approval.

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References

[1] FDA. (2018). TEGSEDI (Inotersen) Approval Announcement.
[2] EMA. (2019). Summary of Product Characteristics for TEGSEDI.
[3] EvaluatePharma. (2022). World Market for Rare Disease Drugs.
[4] American Society of Hematology Guidelines. (2021). Genetic Testing in Amyloidosis.
[5] EvaluatePharma. (2023). Rare Disease Therapeutics - Market Analysis and Forecasts.

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This detailed exploration underscores TEGSEDI’s role within the specialty pharmaceuticals landscape, highlighting crucial factors influencing its market dynamics and financial trajectory.