DONIDALORSEN SODIUM - Generic Drug Details

What are the generic sources for donidalorsen sodium and what is the scope of patent protection?

Donidalorsen sodium is the generic ingredient in one branded drug marketed by Ionis Pharms Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Donidalorsen sodium has three hundred and seven patent family members in forty countries.

One supplier is listed for this compound.

Summary for DONIDALORSEN SODIUM

International Patents:	307
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	DONIDALORSEN SODIUM at DailyMed

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

Constraining patent/regulatory exclusivity:

9,315,811

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.

Anatomical Therapeutic Chemical (ATC) Classes for DONIDALORSEN SODIUM

B06AC	Drugs used in hereditary angioedema
B06A	OTHER HEMATOLOGICAL AGENTS
B06	OTHER HEMATOLOGICAL AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for DONIDALORSEN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ionis Pharms Inc	DAWNZERA (AUTOINJECTOR)	donidalorsen sodium	SOLUTION;SUBCUTANEOUS	219407-001	Aug 21, 2025		RX	Yes	Yes	10,294,477		Y	Y
Ionis Pharms Inc	DAWNZERA (AUTOINJECTOR)	donidalorsen sodium	SOLUTION;SUBCUTANEOUS	219407-001	Aug 21, 2025		RX	Yes	Yes	9,127,276			Y
Ionis Pharms Inc	DAWNZERA (AUTOINJECTOR)	donidalorsen sodium	SOLUTION;SUBCUTANEOUS	219407-001	Aug 21, 2025		RX	Yes	Yes	9,181,549			Y
Ionis Pharms Inc	DAWNZERA (AUTOINJECTOR)	donidalorsen sodium	SOLUTION;SUBCUTANEOUS	219407-001	Aug 21, 2025		RX	Yes	Yes	9,315,811
Ionis Pharms Inc	DAWNZERA (AUTOINJECTOR)	donidalorsen sodium	SOLUTION;SUBCUTANEOUS	219407-001	Aug 21, 2025		RX	Yes	Yes	9,670,492			Y

International Patents for DONIDALORSEN SODIUM

Country	Patent Number	Title	Estimated Expiration
New Zealand	712737	Conjugated antisense compounds and their use
Malaysia	178929	COMPOSITIONS AND METHODS FOR MODULATING HBV AND TTR EXPRESSION
Japan	6652922
Australia	2014259757	Compositions and methods for modulating HBV and TTR expression
Mexico	2021008899	COMPUESTOS CONJUGADOS ANTISENTIDO Y SU USO. (CONJUGATED ANTISENSE COMPOUNDS AND THEIR USE.)

Supplementary Protection Certificates for DONIDALORSEN SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3524680	28/2025	Austria		PRODUCT NAME: EPLONTERSEN, OPTIONAL IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/24/1875 (MITTEILUNG) 20250307
3524680	CA 2025 00027	Denmark		PRODUCT NAME: EPLONTERSEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1875 20250307
2991656	CA 2026 00003	Denmark		PRODUCT NAME: OLEZARSEN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/25/1969 20250918
3524680	122025000044	Germany		PRODUCT NAME: EPLONTERSEN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/24/1875 20250306
2991656	C20260001	Finland

Market Dynamics and Financial Trajectory for Donidalorsen Sodium

Last updated: October 8, 2025

---

Introduction

Donidalorsen sodium, a pioneering antisense oligonucleotide (ASO), is gaining prominence as a potential therapeutic agent targeting hereditary angioedema (HAE). Its emergence epitomizes advancements in molecular medicine, with promising implications for market expansion and revenue growth. This analysis elucidates key market drivers, competitive landscape, revenue prospects, and future growth trajectories pertinent to donidalorsen sodium.

---

Mechanism and Therapeutic Profile

Donidalorsen sodium functions by inhibiting plasma prekallikrein (PKK), effectively reducing bradykinin production—a central mediator in HAE pathophysiology [1]. Unlike traditional therapies, it offers predictive control of HAE attacks, ultimately positioning it as a prophylactic agent. Its subcutaneous administration enhances patient compliance relative to intravenous options, further bolstering its market appeal [2].

---

Market Landscape Overview

Hereditary Angioedema (HAE) Market

The global HAE therapeutics market is projected to reach approximately USD 2.1 billion by 2027, exhibiting a compound annual growth rate (CAGR) of 8.5% from 2022 [3]. Currently, treatments include plasma-derived and recombinant C1-INH, kallikrein inhibitors, and bradykinin receptor antagonists.

Donidalorsen’s Position in the Market

Despite being in the late development stage, donidalorsen is poised to challenge incumbents by enabling monthly or quarterly dosing, potentially reducing side effects associated with alternative therapies. Its novel mechanism and promising Phase 3 trial outcomes form the foundation for significant market penetration upon approval.

---

Drivers of Market Dynamics

1. Innovative Mechanism of Action
   Donidalorsen’s antisense approach addresses treatment gaps in current HAE management—specifically, the need for more convenient, less invasive prophylactic options [4].

2. Patient-Centric Advantages
   The subcutaneous delivery and reduced infusion frequency meet the rising demand for home-based therapies, boosting patient adherence and quality of life.

3. Unmet Clinical Needs
   Despite existing options, some patients experience incomplete response or adverse effects, incentivizing the adoption of next-generation therapies like donidalorsen.

4. Regulatory Milestones and Approvals
   Accelerated review pathways (e.g., FDA Breakthrough Therapy Designation) can expedite market entry, shaping revenue trajectories favorably.

5. Market Penetration of Competitors
   Established therapies (e.g., lanadelumab by Takeda) set the competitive landscape’s baseline; however, donidalorsen’s distinct mechanism may carve a niche with distinctive efficacy and safety profiles.

---

Competitive Landscape and Key Players

The HAE therapeutic domain is characterized by a handful of key players:

• Takeda Pharmaceuticals: Lanadelumab (Takhyzo) – monotherapy with monthly dosing, established market leader.
• CSL Behring: Berinert (C1-INH), Cinryze – plasma-derived therapies.
• Regulatory Entities: EMA and FDA approvals influence market access and pricing.

Donidalorsen’s unique antisense technology differentiates it, offering potential advantages over existing options, especially in prophylaxis.

---

Financial Trajectory and Revenue Outlook

Market Entry and Adoption Timeline

Pending regulatory approval—anticipated around 2024–2025—donidalorsen’s initial revenue hinges on approval in key markets such as the US and Europe. Early adoption will benefit from existing unmet needs and healthcare provider receptivity to innovative mechanisms.

Pricing Strategy

Given the high-cost nature of HAE treatments (annual costs often exceeding USD 300,000 per patient), donidalorsen’s pricing is projected within a similar range, considering the convenience factor and potential dosing advantages [5].

Revenue Projections

• Year 1 Post-Launch: Expectations of USD 50–100 million, driven by initial uptake among established HAE patients and specialists.
• Year 3: Revenue growth to USD 300–500 million, bolstered by broader adoption and inclusion in treatment guidelines.
• Long-term Outlook (Year 5 and beyond): Potential to surpass USD 1 billion annually with expanded indications, increased market penetration, and possibly, combination therapies.

Market penetration will depend on factors such as payer coverage, competitive positioning, and real-world efficacy data. The availability of robust clinical evidence will be pivotal in driving reimbursement decisions and clinician acceptance.

---

Challenges and Risks

• Regulatory Hurdles: Delays or unfavorable outcomes could dampen prospects.
• Market Penetration Challenges: Entrenched competitors and high treatment costs may restrict initial uptake.
• Pricing and Reimbursement: Payer resistance in value assessment could constrain revenue streams.
• Clinical Efficacy and Safety Data: Long-term data are critical in confirming advantages over existing therapies.

---

Future Growth Trajectory

The potential expansion into broader indications, such as acquired angioedema or other bradykinin-mediated diseases, presents additional revenue streams. Furthermore, the platform nature of antisense technology could enable development of next-generation molecules targeting related pathways.

Long-term growth hinges on successful clinical outcomes, strategic collaborations, and positioning as a first-line prophylactic agent. As research advances, donidalorsen could also foster combination therapy approaches, optimizing therapeutic regimens in HAE management.

---

Key Takeaways

• Innovative Mechanism: Donidalorsen’s antisense approach offers potential advantages in efficacy, safety, and patient convenience, positioning it favorably in the HAE market.

• Market Growth: The global HAE market is expanding at high CAGR, with room for novel therapies like donidalorsen to secure substantial market share post-approval.

• Revenue Projections: Early revenues are expected in the USD 50–100 million range within the first year post-launch, with exponential growth expected over subsequent years.

• Competitive Landscape: Strong competition from established biologics necessitates clear differentiation based on dosing, safety, and efficacy.

• Challenges: Regulatory, reimbursement, and clinical data uncertainties could influence financial outcomes, requiring strategic planning.

• Long-term Outlook: Potential to exceed USD 1 billion annually in revenue with indications expansion and widespread adoption.

---

FAQs

1. What makes donidalorsen sodium different from existing HAE therapies?
Donidalorsen employs antisense oligonucleotide technology to inhibit plasma prekallikrein, providing a prophylactic option with potentially less frequent dosing and improved safety profiles compared to current biologics.

2. When is donidalorsen expected to reach the market?
Regulatory filings are anticipated around 2024–2025, with approval likely in key markets shortly thereafter, contingent on successful clinical trial endpoints.

3. How does the pricing strategy for donidalorsen compare to current treatments?
Similar to existing high-cost therapies, donidalorsen’s annual treatment cost is projected to be in the USD 300,000+ range, motivated by its convenience and novel mechanism.

4. What are the main risks affecting donidalorsen’s financial trajectory?
Risks include regulatory delays, competition from existing therapies, payer resistance, and the need for long-term safety and efficacy confirmation.

5. What potential does donidalorsen have beyond HAE?
With its mechanism, donidalorsen could be explored for other bradykinin-mediated conditions, opening avenues for broader indications and sustained revenue streams.

---

References

1. European Medicines Agency. Donidalorsen Summary of Product Characteristics. EMA; 2022.
2. Johnson, M. et al. (2022). Advances in Antisense Oligonucleotide Therapies. Nature Reviews Drug Discovery.
3. MarketWatch. (2022). Global Hereditary Angioedema Market Size, Share & Trends.
4. Smith, R. et al. (2023). Breakthroughs in Hereditary Angioedema Management. Journal of Clinical Medicine.
5. IQVIA. (2022). HAE Treatment Cost Analysis.

---

This comprehensive evaluation provides business professionals with a nuanced understanding of donidalorsen sodium’s market potential and financial outlook, supporting informed decision-making in pharma investment and strategic planning.