SPINRAZA Drug Patent Profile

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

Spinraza is a drug marketed by Biogen Idec and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and five patent family members in twenty-eight countries.

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

DrugPatentWatch^® Generic Entry Outlook for Spinraza

Spinraza was eligible for patent challenges on December 23, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 23, 2030. This may change due to patent challenges or generic licensing.

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SPINRAZA

International Patents:	105
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	12
Patent Applications:	471
Drug Prices:	Drug price information for SPINRAZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPINRAZA
What excipients (inactive ingredients) are in SPINRAZA?	SPINRAZA excipients list
DailyMed Link:	SPINRAZA at DailyMed

See drug prices for SPINRAZA

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

NDA:

209531

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 SPINRAZA

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

Sponsor	Phase
Biogen	Phase 4
NYU Langone Health	Early Phase 1
Winthrop University Hospital	Early Phase 1

See all SPINRAZA clinical trials

Pharmacology for SPINRAZA

Drug Class	Antisense Oligonucleotide Survival Motor Neuron-2-directed RNA Interaction
Physiological Effect	Increased Protein Synthesis

US Patents and Regulatory Information for SPINRAZA

SPINRAZA is protected by twenty-six US patents.

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 Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes

Expired US Patents for SPINRAZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016

International Patents for SPINRAZA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1247103	調節SMN2剪接的組合物和方法 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING)
European Patent Office	1743901
Australia	9070401
Hungary	T63650
Austria	318273

Supplementary Protection Certificates for SPINRAZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2548560	2017C/048	Belgium		PRODUCT NAME: SPINRAZA - NUSINERSEN; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601
2548560	57/2017	Austria		PRODUCT NAME: NUSINERSEN UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/17/1188 MITTEILUNG 20170601
2548560	C 2017 045	Romania		PRODUCT NAME: NUSINERSEN SAU SARURI ALE ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1188; DATE OF NATIONAL AUTHORISATION: 20170530; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1188; DATE OF FIRST AUTHORISATION IN EEA: 20170530
1910395	2017/051	Ireland		PRODUCT NAME: NUSINERSEN OR SALTS THEREOF; REGISTRATION NO/DATE: EU/1/17/1188 20170530
2548560	797	Finland

Market Dynamics and Financial Trajectory for SPINRAZA (Nusinersen)

Last updated: November 8, 2025

Introduction

SPINRAZA (nusinersen) stands as a groundbreaking therapy in the treatment of spinal muscular atrophy (SMA), a rare genetic disorder characterized by progressive muscle degeneration leading to severe disability and mortality. Since its approval in December 2016 by the U.S. Food and Drug Administration (FDA), SPINRAZA has transformed the SMA treatment landscape, catalyzing notable shifts in market dynamics and demonstrating a compelling financial trajectory for its manufacturer, Biogen. This analysis explores the evolving market environment, competitive landscape, regulatory influences, and financial metrics shaping SPINRAZA’s trajectory.

Market Landscape and Epidemiological Drivers

Prevalence of Spinal Muscular Atrophy

SMA affects approximately 1 in 10,000 live births worldwide, with an estimated 350,000 to 400,000 individuals impacted globally. In the United States alone, the number of SMA patients ranges from 9,000 to 11,000, with a significant subset classified as Type I (severe form diagnosed early), Type II, or Type III. The advent of gene-targeted therapies has expanded the treatment landscape, but SPINRAZA remains a front-runner due to its early market entry and extensive clinical validation.

Market Penetration and Patient Access

Initially, SPINRAZA's market penetration was constrained by high costs, administration complexities (intrathecal injections requiring specialized medical settings), and limited awareness. Over time, increased clinical familiarity, expanded payer coverage, and the development of administration protocols have improved access, particularly in developed economies.

Regulatory Milestones and Label Expansion

Initial Approval and Indications

FDA approval in 2016 authorized SPINRAZA for infantile-onset and later pediatric SMA. EMA approvals followed, with subsequent label expansions for broader age groups and disease severities, reflecting accumulating clinical evidence[1].

Global Approvals and Reimbursement Landscape

Biogen secured private and public reimbursement arrangements in key markets, including the U.S., EU, and Japan. However, high treatment costs—approximately $125,000 per dose—necessitated negotiation with payers, shaping the drug's financial model[2].

Competitive Dynamics

Emergence of Gene Therapies

The approval of therapies like Zolgensma (AVXS-101) by Novartis/Avexis in 2019 introduced a novel, potentially curative, gene replacement approach. While Zolgensma boasts advantages such as a single-dose regimen, its higher upfront costs and logistical challenges created a nuanced competitive landscape. SPINRAZA’s longer clinical track record and established safety profile sustain its relevance[3].

Other Pharmacological Agents

Nusinersen's competitors include risdiplam (Evrysdi, Roche), approved in 2020, offering oral administration. Risdiplam’s ease of use and competitive pricing have begun to erode some of SPINRAZA’s market share, particularly in pediatric populations[4].

Market Dynamics Influencing Financial Trajectory

Pricing Strategies and Revenue Generation

Biogen’s premium pricing model, coupled with expanding indications, initially drove robust revenues. In Q2 2022, SPINRAZA generated approximately $431 million globally, reflecting stable demand and ongoing payer negotiations[5].

Market Penetration and Uptake Trends

The drug’s growth aligns with increasing diagnosis rates, especially with newborn screening initiatives in several regions. In the U.S., the implementation of newborn screening for SMA has led to earlier diagnoses, enabling timely intervention with SPINRAZA, thereby enhancing market expansion prospects.

Manufacturing and Supply Chain Factors

Biogen has optimized manufacturing to meet global demand, yet supply chain disruptions—exacerbated by the COVID-19 pandemic—have momentarily impacted distribution. Ongoing capacity expansion aims to sustain revenue growth[6].

Pricing and Reimbursement Challenges

Payor pushback against high drug prices remains a concern. Biogen’s efforts to negotiate coverage, introduce risk-sharing agreements, and demonstrate cost-effectiveness have been critical to maintaining revenue streams[7].

Financial Outlook and Growth Projections

Revenue Projections

Analysts project SPINRAZA's global sales to approach $2 billion annually over the next three years, assuming stable market penetration, acceptance of new indications, and competitive positioning against emerging therapies[8].

Impact of Competitive and Market Forces

• Gene therapy competition: Zolgensma’s potential to replace multiple doses with a one-time treatment could diminish SPINRAZA’s long-term revenue unless Biogen enhances its value proposition through formulary inclusion and differentiated safety profile.

• Oral therapies: Risdiplam's market entry complicates payers' and clinicians' treatment choices, potentially impacting SPINRAZA's revenue share.

Regulatory and Clinical Developments

Additional label expansions, especially in adult SMA, could further boost sales. Conversely, safety concerns or adverse event reports may influence formularies.

Conclusion: Future Market and Financial Trajectory

SPINRAZA’s market trajectory remains favorable given the growing SMA diagnosis base, payer acceptance, and established clinical utility. However, competition from gene therapies and other molecular treatments necessitates continuous innovation, cost management, and strategic partnerships. Overall, BIogen’s ability to navigate regulatory, competitive, and reimbursement landscapes will determine its sustained financial performance.

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Key Takeaways

• Growing Overall Market: The increasing global diagnosis of SMA, driven by newborn screening programs, underpins sustained demand for SPINRAZA.

• Competitive Pressures: Gene therapies like Zolgensma and orally administered risdiplam challenge SPINRAZA’s market dominance, prompting a need for value differentiation.

• Pricing and Payer Dynamics: High treatment costs necessitate ongoing negotiations; innovative reimbursement models are critical for maintaining revenue flow.

• Innovation and Label Expansion: Broader indications and evolving clinical evidence will drive future sales, especially if approved for adult SMA.

• Financial Outlook: Despite competitive threats, stable demand and a solid clinical profile position SPINRAZA as a key revenue generator for Biogen, with projections indicating steady growth in the short to medium term.

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FAQs

1. How does SPINRAZA compare with emerging SMA treatments in terms of efficacy and safety?
SPINRAZA has demonstrated significant efficacy in improving motor function and survival in SMA patients, with an extensive safety profile established over years of use. While gene therapies like Zolgensma aim for a complete cure, they are limited by their age restrictions and potential safety concerns. Risdiplam offers comparable efficacy with oral administration, providing a competitive alternative.

2. What are the key factors influencing payer acceptance of SPINRAZA?
Payer acceptance hinges on demonstrating clinical value, cost-effectiveness, and long-term health economic benefits. Biogen’s negotiations, risk-sharing arrangements, and evidence of improved patient outcomes have been instrumental in securing coverage.

3. What is the potential for SPINRAZA’s use in adult SMA populations?
Label expansions are underway, with ongoing clinical trials assessing efficacy in adults. Expanded indications could unlock new revenue streams, especially as diagnosis and awareness increase among adult patients.

4. How does the administration complexity affect SPINRAZA’s market penetration?
Intrathecal injections administered by specialists limit access in settings lacking infrastructure. Streamlining administration or developing alternative delivery modes could enhance uptake.

5. What strategies can Biogen employ to maintain SPINRAZA’s market share amid competition?
Continued clinical research, label extension, patient-centered programs, flexible pricing models, and investments in patient access initiatives are vital to sustaining relevance.

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References

[1] U.S. Food and Drug Administration. (2016). FDA Approves First Treatment for Spinal Muscular Atrophy.
[2] IQVIA. (2022). Biogen’s SPINRAZA Market Access and Pricing Dynamics.
[3] Novartis. (2019). Zolgensma (onasemnogene abeparvovec) approved for SMA.
[4] Roche. (2020). Risdiplam approval for SMA.
[5] Biogen Q2 2022 Earnings Report.
[6] Reuters. (2022). Supply chain disruptions impacting biologics manufacturing.
[7] Deloitte. (2021). Navigating Reimbursement Challenges in Rare Disease Therapies.
[8] EvaluatePharma. (2022). SMA Market Forecast and Sales Projections.