QALSODY Drug Patent Profile

When do Qalsody patents expire, and when can generic versions of Qalsody launch?

Qalsody is a drug marketed by Biogen Ma and is included in one NDA. There are three patents protecting this drug.

This drug has sixty-eight patent family members in twenty-nine countries.

The generic ingredient in QALSODY is tofersen. One supplier is listed for this compound. Additional details are available on the tofersen profile page.

DrugPatentWatch^® Generic Entry Outlook for Qalsody

Qalsody will be eligible for patent challenges on April 25, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 25, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for QALSODY

International Patents:	68
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for QALSODY
What excipients (inactive ingredients) are in QALSODY?	QALSODY excipients list
DailyMed Link:	QALSODY at DailyMed

See drug prices for QALSODY

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

Constraining patent/regulatory exclusivity:

TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE

NDA:

215887

Dosage:

SOLUTION;INTRATHECAL

^*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 QALSODY

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Biogen	PHASE4

See all QALSODY clinical trials

Pharmacology for QALSODY

Drug Class

Antisense Oligonucleotide

US Patents and Regulatory Information for QALSODY

QALSODY is protected by three US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE.

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
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	10,968,453
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	10,669,546
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes	10,385,341		Y	Y
Biogen Ma	QALSODY	tofersen	SOLUTION;INTRATHECAL	215887-001	Apr 25, 2023		RX	Yes	Yes

International Patents for QALSODY

See the table below for patents covering QALSODY around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	724100
South Korea	20240111010
Israel	273404
Canada	2942394	COMPOSITIONS MODULANT L'EXPRESSION DE SOD-1 (COMPOSITIONS FOR MODULATING SOD-1 EXPRESSION)
European Patent Office	4137573

Supplementary Protection Certificates for QALSODY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3126499	C20240035	Finland
3126499	2490031-8	Sweden		PRODUCT NAME: TOFERSEN; REG. NO/DATE: EU/1/23/1783 20240603
3126499	34/2024	Austria		PRODUCT NAME: TOFERSEN; REGISTRATION NO/DATE: EU/1/23/1783 (MITTEILUNG) 20240603
3126499	122024000060	Germany		PRODUCT NAME: TOFERSEN; REGISTRATION NO/DATE: EU/1/23/1783 20240529
3126499	24C1039	France		PRODUCT NAME: TOFERSEN; REGISTRATION NO/DATE: EU/1/23/1783 20240603

Market Dynamics and Financial Trajectory for QALSODY

Last updated: July 28, 2025

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Introduction

QALSODY, approved by the U.S. Food and Drug Administration (FDA) in September 2022, is a groundbreaking therapeutic aimed at treating amyotrophic lateral sclerosis (ALS). As a monoclonal antibody targeting the misfolded protein SOD1, QALSODY represents a significant advance in personalized neurology, positioning itself at the nexus of high unmet need and innovative drug development. This article analyzes the evolving market landscape and financial outlook for QALSODY, considering competitive forces, regulatory trends, commercialization strategies, and broader industry shifts.

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Market Landscape for ALS Therapeutics

The global ALS therapeutics market, valued at approximately $400 million in 2022, is marked by limited treatment options, high unmet needs, and rapid innovation[1]. Currently, Riluzole and Edaravone are the only FDA-approved drugs, offering modest survival benefits. The market's growth trajectory hinges on the advent of targeted, disease-modifying agents like QALSODY.

Increasing diagnostic rates, advancements in biomarker development, and a growing patient population are expected to augment market size. The ALS demographic predominantly comprises patients aged 40–70, with an estimated 30,000–40,000 cases in the U.S. alone, translating into a substantial commercial opportunity.

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Competitive and Innovation Dynamics

QALSODY's monotherapy, targeting SOD1 mutations, positions it within the personalized medicine subset, but its commercial success will depend on multiple factors:

• Precision medicine push: Given its specificity for SOD1 mutation carriers (~2% of ALS patients), QALSODY targets a niche but highly impactful segment. The small population size limits total market potential but allows for premium pricing and demonstrable clinical benefits.

• Emerging therapies: Biogen, Ionis Pharmaceuticals, and other biotech firms are developing gene therapies, antisense oligonucleotides, and other monoclonal antibodies targeting ALS pathways[2]. The competitive landscape is evolving, with potential for co-therapies and combination regimes.

• Regulatory trends: Fast-track designation, orphan drug status, and potential for accelerated approval pathways are instrumental in expediting market entry and market penetration.

• Reimbursement environment: Payer acceptance hinges on demonstrated efficacy, cost-effectiveness, and clear clinical benefit. The high cost of biologics demands robust cost-benefit analyses, influencing access and adoption.

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Financial Trajectory and Revenue Potential

QALSODY’s commercial prospects depend on several intertwined factors:

Pricing and Revenue Model

As a biologic targeting a rare subset, QALSODY likely employs a premium pricing strategy. Historical data for ALS drugs suggests prices in the range of $150,000 to $300,000 per year per patient[3]. If QALSODY is priced at approximately $200,000 annually, with an initial target population of 1,000 patients in the U.S., the first-year revenue potential could reach $200 million.

Market Penetration and Adoption

Initially, adoption will be constrained by the identification of eligible patients through genetic testing for SOD1 mutations. As diagnostic testing becomes more widespread, particularly with insurance coverage for genetic screening, the eligible patient pool expansion could amplify revenues.

Assuming a 20-30% market share within the SOD1-affected population, the revenue could scale to $60–$120 million annually within the first 3–5 years.

Global Expansion

While FDA approval is the initial market catalyst, subsequent approval in Europe, Japan, and other territories presents additional revenue streams. The global ALS therapeutics market, projected to reach over $650 million by 2025, will see QALSODY competing for share as access expands.

Cost of Commercialization

High manufacturing costs, supply chain logistics for biologics, and marketing to neurologists and genetic counselors contribute to initial expense outlays. However, as manufacturing scales, per-unit costs are expected to decrease.

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Regulatory and Market Entry Risks

QALSODY’s financial success is contingent on sustained regulatory support and access:

• Efficacy evidence: If confirmatory trials demonstrate significant disease modification, payer confidence and reimbursement levels will increase, positively impacting revenues.

• Safety profile: Safety signals can delay approval or restrict usage, dampening financial trajectories.

• Market acceptance: Limited awareness and the need for specialized testing could slow adoption, affecting revenue acceleration.

• Intellectual property: Strong patent protection extending at least 10–12 years post-approval will be crucial to sustain competitive advantage and maximize return on investment.

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Industry and Market Influences

Transformative trends influencing QALSODY’s trajectory include:

• Advances in genetic diagnostics: Expanding testing availability broadens the eligible patient base.

• Orphan drug policies: Regulatory incentives extend market exclusivity and reduce development costs, bolstering financial prospects.

• Biotech financing climate: Investment influx in neurodegeneration enhances R&D pipelines, heightening future competition but also supporting continued innovation.

• Healthcare policy shifts: Emphasis on personalized medicine and rare disease treatments could favor reimbursement policies, especially when backed by clinical efficacy.

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Long-term Outlook and Strategic Implications

While QALSODY currently addresses a small patient subset, its success could catalyze broader use cases in neurodegeneration and personalized therapeutics. Success stories in rare neurological diseases often lead to broader indications and pipeline expansion, estimating long-term revenues potentially reaching several hundred million dollars annually.

Strategic partnerships, licensing agreements, and continued R&D investment will be essential to expand the drug's scope, improve delivery mechanisms, and explore combination therapies, collectively impacting its financial profile positively.

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Key Takeaways

• QALSODY operates within a niche but high-value segment targeting SOD1 mutation carriers with ALS, offering significant yet specialized commercial opportunities.

• The drug’s revenue potential hinges on pricing strategies, market penetration, diagnostic integration, and regulatory support, with initial projections around $200 million annually in the U.S.

• Competitive dynamics, emerging therapies, and regulatory landscapes are critical factors influencing financial outcomes. Strategic collaborations and patent protections will be necessary to sustain market leadership.

• Global expansion and evolving healthcare policies favoring rare disease therapeutics will further enhance QALSODY’s long-term financial trajectory.

• Broader implications of QALSODY’s success could include expansion into additional neurodegenerative indications, reinforcing its position within personalized medicine.

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FAQs

1. What factors will most influence QALSODY's market penetration?
Market penetration will depend on diagnostic adoption for SOD1 mutations, clinician awareness, regulatory approval in multiple territories, and payer reimbursement policies.

2. How does the rarity of SOD1 mutations affect QALSODY’s profitability?
While the small patient population limits total addressable market, high drug pricing and targeted therapy benefit profitability within this niche, especially with regulatory incentives.

3. What is the competitive landscape for ALS treatments?
Currently, limited options exist; emerging therapies, including gene therapies and antisense oligonucleotides, could compete directly or complement QALSODY, impacting market share.

4. How might global regulatory developments influence QALSODY’s financial outlook?
Approval in key international markets, facilitated by orphan drug designations, can significantly expand revenue, offsetting limited domestic growth.

5. What long-term strategies can maximize QALSODY's commercial success?
Expanding indications, establishing strong diagnostic pathways, forming strategic partnerships, and maintaining patent protections are essential for sustained growth.

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References

[1] Grand View Research. (2022). ALS Therapeutics Market Size, Share & Trends.
[2] NeuroNews. (2022). Emerging Therapies for ALS: A Competitive Landscape.
[3] Lazard. (2021). Pricing Strategies for Rare Disease Biologics.