Inotersen sodium - Generic Drug Details

What are the generic sources for inotersen sodium and what is the scope of freedom to operate?

Inotersen sodium is the generic ingredient in one branded drug marketed by Akcea Theraps and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Inotersen sodium has thirty-five patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for inotersen sodium

International Patents:	35
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	inotersen sodium at DailyMed

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

Constraining patent/regulatory exclusivity:

8,697,860

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.

Pharmacology for inotersen sodium

Drug Class	Antisense Oligonucleotide Transthyretin-directed RNA Interaction
Physiological Effect	Decreased RNA Integrity Increased Protein Breakdown

Anatomical Therapeutic Chemical (ATC) Classes for inotersen sodium

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for inotersen sodium

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	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	9,399,774
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		DISCN	Yes	No	8,697,860		Y

Expired US Patents for inotersen sodium

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 inotersen sodium

Country	Patent Number	Title	Estimated Expiration
Cyprus	1119070
Cyprus	D2019001
China	103038345	Modulation of transthyretin expression
Portugal	2563920
Canada	2994063	MODULATION DE L'EXPRESSION DE LA TRANSTHYRETINE (MODULATION OF TRANSTHYRETIN EXPRESSION)
Japan	2013526860

Supplementary Protection Certificates for inotersen sodium

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
2563920	LUC00096	Luxembourg		PRODUCT NAME: INOTERSEN AND SALTS THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1296 20180710
2563920	1990001-8	Sweden		PRODUCT NAME: INOTERSEN AND SALTS THEREOF; REG. NO/DATE: EU/1/18/1296 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

Market Dynamics and Financial Trajectory for INOTERSEN SODIUM

Last updated: July 28, 2025

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Introduction

Inotersen sodium, marketed under the brand name Tegsedi, is a pivotal therapeutic agent targeting hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). As a site-specific antisense oligonucleotide (ASO), it modulates transthyretin (TTR) protein synthesis, thereby halting disease progression. Given its unique mechanism and significant clinical implications, understanding its market dynamics and financial trajectory offers key insights for stakeholders, including investors, healthcare providers, and pharmaceutical strategists.

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Market Landscape: Disease Prevalence and Unmet Medical Needs

Hereditary transthyretin amyloidosis is a rare, inherited neurodegenerative disorder characterized by amyloid fibril deposition in multiple organ systems. Its prevalence varies geographically, but estimates suggest approximately 50,000 to 100,000 individuals worldwide are affected [1]. The disease often presents with peripheral neuropathy, cardiomyopathy, and progressive disability, reflecting substantial morbidity and mortality.

Historically, limited treatment options existed, intensifying the demand shift toward innovative therapeutics. The advent of inotersen was a significant milestone, addressing the unmet need for disease-modifying therapies that can improve or stabilize clinical outcomes.

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Market Dynamics

Regulatory Approvals and Global Reach

Inotersen was approved by the U.S. Food and Drug Administration (FDA) in 2018 [2], swiftly followed by approvals from the European Medicines Agency (EMA) and other regulatory bodies. Its regulatory success was driven by robust Phase 3 trial data demonstrating efficacy in slowing neuropathy progression, alongside manageable safety profiles.

The global regulatory landscape is evolving, with expansions into markets such as Japan and Canada, providing broader access. The approval timelines and local pricing strategies significantly influence its intraregional market penetration.

Competitive Environment

The entrance of patisiran (Onpattro) from Alnylam Pharmaceuticals in 2018 introduced a competing RNA interference (RNAi) therapeutic, challenging inotersen’s market dominance [3]. While both target TTR suppression, their differing safety profiles, administration routes, and dosing regimens influence prescribing patterns.

Emerging therapies, including gene editing approaches and other antisense modalities, threaten to disrupt the current market equilibrium, intensifying competition.

Pricing, Reimbursement, and Accessibility

Inotersen’s premium pricing (approximating $450,000 annually in the U.S.) reflects high R&D costs, manufacturing complexity, and value proposition. Reimbursement policies significantly impact uptake; payers scrutinize long-term clinical benefits versus costs, especially considering rare disease populations.

Particularly in Europe and emerging markets, reimbursement negotiations are pivotal, with some regions implementing managed entry agreements and patient access schemes, which influence sales volumes.

Market Penetration and Adoption Challenges

Factors influencing adoption include:

• Safety profile concerns: Risk of thrombocytopenia and renal adverse events necessitates rigorous monitoring, potentially impeding clinician confidence.
• Administration barriers: Intravenous delivery requires specialized infusion centers, constraining access in remote or resource-limited settings.
• Disease awareness: Underdiagnosis of hATTR amyloidosis affects patient identification and treatment initiation.

Financial Trajectory

Revenue Trends and Forecasts

Following FDA and global approvals, inotersen generated approximately $150 million in annual sales by 2022 [4]. Growth trajectories are projected to accelerate with increased geographical adoption and expanded indications. Market analysts estimate a compound annual growth rate (CAGR) of 15-20% over the next five years, contingent on factors including:

• Improved diagnosis rates
• Broader payer acceptance
• Competitive advancements

Pipeline and Lifecycle Management

Pipeline development aims to enhance existing therapies and explore adjunctive treatments. Notably, modifications aimed at reducing adverse effects and simplifying administration may bolster its financial appeal.

Lifecycle management strategies include:

• Combination therapies: Exploring synergies with other agents
• Formulation innovations: Transitioning to subcutaneous delivery
• Biomarker development: Enhancing patient stratification and response monitoring

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Regulatory and Market Trends Impacting Financial Outlook

Market forecasts must account for:

• Regulatory shifts: Accelerated approvals, orphan drug designations, and potential inclusion in combination regimens.
• Pricing reforms: Payer push for value-based pricing models and potential for biosimilar or generic competitors.
• Market access strategies: Local reimbursement negotiations and patient assistance programs.

The evolving landscape underscores the importance of strategic adaptability for sustaining revenue streams.

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Conclusion

Inotersen sodium’s market dynamics are shaped by its clinical efficacy, competitive positioning, regulatory environment, and pricing strategies. Its financial trajectory is promising yet beset with challenges from emerging therapies and shifting healthcare policies. Continuous innovation, strategic market expansion, and rigorous safety management are imperative to optimize its commercial potential.

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Key Takeaways

• Strong Market Position: Inotersen remains a leading therapy for hATTR amyloidosis but faces increasing competition from RNAi agents like Patisiran.
• Global Expansion: Regulatory approvals across multiple regions are steadily increasing its market reach; however, reimbursement hurdles persist.
• Financial Outlook: Anticipated high-growth trajectory driven by increased adoption, though vulnerable to pricing pressures and biosimilar competition.
• Operational Challenges: Safety concerns and administration complexities require ongoing mitigation to maintain clinician and patient confidence.
• Strategic Focus: Pipeline development and lifecycle management are critical for sustained profitability.

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FAQs

1. What are the primary advantages of inotersen over competing therapies?
   Inotersen offers demonstrated efficacy in slowing disease progression with a manageable safety profile, although its intravenous administration and safety monitoring requirements are considerations.

2. How does the pricing of inotersen impact its market adoption?
   Its high cost limits access in some regions, with reimbursement negotiations and patient assistance programs playing pivotal roles in facilitating treatment initiation.

3. What long-term market prospects exist for inotersen?
   Long-term prospects depend on pipeline innovations, expanded indications, and strategies to mitigate safety concerns, ensuring competitive advantage amid emerging therapies.

4. Are there any significant regulatory hurdles impacting inotersen’s growth?
   Continued safety surveillance and post-marketing trial results are essential for maintaining regulatory approvals and expanding market access.

5. How does the competitive landscape affect inotersen’s financial trajectory?
   The rise of RNAi-based therapies and potential biosimilars could pressure prices and market share, underscoring the necessity for differentiation and innovation.

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References

1. Hereditary Transthyretin Amyloidosis (hATTR): Epidemiology and Disease Burden.
2. FDA Approval of Tegsedi (Inotersen).
3. Patisiran (Onpattro) vs. Inotersen: Market Competition.
4. Pharma Sales Data Analysis 2022.

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