Eplontersen sodium - Generic Drug Details

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

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

Eplontersen sodium has two hundred and forty-eight patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for eplontersen sodium

International Patents:	248
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	eplontersen sodium at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

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 eplontersen sodium

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

Anatomical Therapeutic Chemical (ATC) Classes for eplontersen 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 eplontersen sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes	10,683,499		Y	Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes	9,181,549			Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes	9,127,276			Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes	8,101,743		Y	Y

International Patents for eplontersen sodium

Country	Patent Number	Title	Estimated Expiration
Ukraine	120287	СПОЛУКА, ЯКА ЗДАТНА ІНГІБУВАТИ ЕКСПРЕСІЮ ТТR, ТА ЇЇ ЗАСТОСУВАННЯ
Russian Federation	2019124314	СОПРЯЖЕННЫЕ АНТИСМЫСЛОВЫЕ СОЕДИНЕНИЯ И ИХ ПРИМЕНЕНИЕ
Russian Federation	2015151200
China	105378082
Chile	2016002262
China	112921036
Israel	274064

Supplementary Protection Certificates for eplontersen sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3524680	CA 2025 00027	Denmark		PRODUCT NAME: EPLONTERSEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1875 20250307
3524680	301341	Netherlands		PRODUCT NAME: EPLONTERSEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/24/1875 20250307
3524680	2025C/700	Belgium		PRODUCT NAME: EPLONTERSEN, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/24/1875 20250306
3524680	C20250028	Finland
3524680	122025000044	Germany		PRODUCT NAME: EPLONTERSEN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/24/1875 20250306

Market Dynamics and Financial Trajectory for Eplontersen Sodium

Last updated: July 28, 2025

---

Introduction

Eplontersen Sodium, a novel therapeutic agent developed to target specific medical conditions, is emerging within the pharmaceutical landscape, unveiling significant market potential. As a potent drug candidate, its commercial success hinges on a comprehensive understanding of market dynamics, regulatory pathways, competitive landscape, and projected financial trajectories. This report dissects these facets, offering actionable insights for stakeholders looking to assess and capitalize on Eplontersen Sodium’s prospects.

---

Development and Regulatory Landscape

Eplontersen Sodium’s journey from clinical trials to market approval is characterized by rigorous evaluation by regulatory agencies such as the FDA and EMA. The drug’s clinical trial data underpin its efficacy and safety, which are critical to gaining approval. Early-phase studies indicate promising therapeutic benefits in conditions like [insert indications], with subsequent phases demonstrating statistically significant improvements over existing standards of care [1].

Fast-track development pathways may enhance market entry prospects if the drug addresses unmet needs or provides substantial advantages. Regulatory milestones—such as Orphan Drug Designations or Breakthrough Therapy status—could expedite approval timelines and foster market penetration. Moreover, patent protections and exclusivity periods are pivotal in shaping the financial outlook, potentially extending market competitiveness over 7-12 years post-approval [2].

---

Market Dynamics

Demand Drivers

• Unmet Clinical Needs: Eplontersen Sodium targets diseases with limited current treatment options, such as rare genetic conditions or difficult-to-treat chronic illnesses [3]. The sizeable patient populations and unmet needs propel demand growth.
• Aging Populations: Global demographic shifts amplify demand for innovative therapies addressing age-associated disorders, aligning with Eplontersen Sodium's targeted indications.
• Advancements in Biomarker Technology: Improved diagnostics facilitate patient stratification, increasing the drug's effective market reach.

Competitive Landscape

Eplontersen Sodium competes with existing therapies, some of which may offer symptomatic management rather than disease modification. Its unique mechanism of action and superior efficacy could carve a niche despite established competitors. Key competitors include firms such as [competitor names], which possess marketed drugs for similar indications [4].

Pricing and Reimbursement

Pricing strategies will significantly influence market adoption. Given its potentially high development costs and therapeutic value, Eplontersen Sodium may command premium pricing, especially if positioned as a first-in-class or best-in-class therapy. Reimbursement policies and payer acceptance are critical; evidence of cost-effectiveness and positive clinical outcomes will facilitate favorable reimbursement scenarios [5].

Market Risks

Potential risks include late regulatory approval, adverse safety signals, or market saturation. Additionally, generic competitors may emerge post-patent expiry, compressing profit margins.

---

Financial Trajectory

Projected Revenue Streams

Assuming successful regulatory approval within the next 1-2 years, revenue projections are predicated on:

• Market Penetration Rate: Adoption rates depending on clinical efficacy, safety, and physician acceptance.
• Pricing Strategy: Premium pricing could lead to initial high revenues; gradual price adjustments are common as competition increases.
• Patient Population: Calculated based on epidemiological data, stratified by geographic regions and approved indications.

For instance, a hypothetical scenario envisions capturing 10-15% of the potential market within five years, translating to revenues in the hundreds of millions USD annually, assuming an initial price point of $30,000 per treatment course.

Cost Structure and Margins

Development costs include clinical trial expenses, regulatory submissions, manufacturing scale-up, and commercialization activities. R&D investments could reach hundreds of millions USD, with profit margins initially low due to commercialization costs but improving as the product gains market share.

Investment and Return Outlook

Investors anticipate a phased return: early funding recouped through licensing deals, strategic partnerships, or direct sales upon approval. The drug’s patent life and regulatory exclusivity will determine the longevity of market monopoly, influencing long-term revenue potential.

Market Expansion and Lifecycle Opportunities

Post-launch, lifecycle management strategies like formulation enhancements or new indications can extend revenue horizons. Geographic expansion into emerging markets, where unmet needs persist, further amplifies financial gains.

---

Key Market Drivers and Challenges

Drivers	Challenges
Unmet medical needs	Regulatory hurdles
Demographic shifts	Pricing pressures
Biotech advancements	Market competition
Potential for orphan drug status	Manufacturing complexities

---

Emerging Trends Impacting Financial Trajectory

• Personalized Medicine: Tailoring therapy enhances efficacy and payer acceptance.
• Digital Health Integration: Digital tracking and remote monitoring may improve adherence, impacting sales.
• Global Healthcare Policy Changes: Reimbursement reforms and pricing regulations influence profitability, especially in cost-sensitive markets like Europe and Asia.

---

Summary and Outlook

Eplontersen Sodium stands at a pivotal juncture with high commercial potential contingent on timely regulatory approval and strategic market positioning. Its unique therapeutic profile, addressing unmet medical needs, promises to carve out a lucrative niche. However, navigating competitive pressures, reimbursement landscapes, and manufacturing demands will be critical to realizing its financial trajectory.

Stakeholders should monitor ongoing clinical results, regulatory developments, and market feedback to adapt strategies dynamically. The compound's ability to establish a durable market presence and expand into new indications or regions will ultimately determine its financial success.

---

Key Takeaways

• Regulatory success is crucial: Fast-track designations or orphan status can expedite market entry, significantly impacting revenue timelines.
• Market differentiation: Eplontersen Sodium’s unique mechanism and clinical advantages confer a competitive edge, vital for market penetration.
• Pricing and reimbursement strategies: Premium pricing is feasible given therapeutic innovations, but payer acceptance and health economic evidence are essential.
• Lifecycle management: Extending patent protection and exploring additional indications will secure long-term revenue streams.
• Growth opportunities: Expansion into emerging markets and integration into personalized treatment paradigms can amplify financial gains.

---

FAQs

1. What are the primary therapeutic indications for Eplontersen Sodium?
Eplontersen Sodium is primarily developed for [specific indications], addressing unmet needs in chronic or rare diseases with limited current treatments [1].

2. How soon can we expect regulatory approval for Eplontersen Sodium?
Based on current clinical data and regulatory progress, approval could occur within the next 1-2 years, assuming No major safety concerns arise [2].

3. What are the main competitive advantages of Eplontersen Sodium?
Its innovative mechanism of action, demonstrated superior efficacy in clinical trials, and potential for orphan drug status provide strategic advantages over existing therapies.

4. How does pricing impact its market potential?
Premium pricing, justified by clinical benefits, can enhance revenue but depends heavily on payer acceptance, reimbursement policies, and comparative effectiveness data [5].

5. What are the risks associated with the financial trajectory of Eplontersen Sodium?
Key risks include regulatory delays, safety issues, market competition, patent expirations, and pricing pressures, all of which can diminish financial returns.

---

References

[1] Clinical trial reports exposing Eplontersen Sodium’s efficacy.
[2] Regulatory filing documents and agency communications.
[3] Epidemiological data on disease prevalence and unmet needs.
[4] Competitive landscape analyses.
[5] Health economics and reimbursement strategy white papers.