NUSINERSEN SODIUM - Generic Drug Details

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

Nusinersen sodium is the generic ingredient in one branded drug marketed by Biogen Idec and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nusinersen sodium has one hundred and six patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for NUSINERSEN SODIUM

International Patents:	106
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUSINERSEN SODIUM
DailyMed Link:	NUSINERSEN SODIUM at DailyMed

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

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.

Pharmacology for NUSINERSEN SODIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for NUSINERSEN SODIUM

M09AX	Other drugs for disorders of the musculo-skeletal system
M09A	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M09	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M	Musculo-skeletal system

US Patents and Regulatory Information for NUSINERSEN SODIUM

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

Expired US Patents for NUSINERSEN SODIUM

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 NUSINERSEN SODIUM

Country	Patent Number	Title	Estimated Expiration
Portugal	3308788
China	115227710
European Patent Office	3305302	COMPOSITIONS ET MÉTHODES POUR MODULER L'ÉPISSAGE DE SMN2 CHEZ UN SUJET (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING IN A SUBJECT)
Japan	6064139
Israel	245096	שימוש בתרכובת אנטיסנסית להכנת תרופה לשינוי שחבור של smn2 במטופל (Use of an antisense compound for the preparation of a medicament for modulation of smn2 splicing in a subject)
Russian Federation	2683772	КОМПОЗИЦИИ И СПОСОБЫ МОДУЛЯЦИИ SMN2 СПЛАЙСИНГА У СУБЪЕКТА (COMPOSITIONS AND METHODS OF SML2 SPLICING MODULATION IN SUBJECT)
Russian Federation	2683772

Supplementary Protection Certificates for NUSINERSEN SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2548560	PA2017037	Lithuania		PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530
2548560	PA2017037,C2548560	Lithuania		PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530
2548560	C20170038 00228	Estonia		PRODUCT NAME: NUSINERSEEN;REG NO/DATE: EU/1/17/1188 01.06.2017
2548560	57/2017	Austria		PRODUCT NAME: NUSINERSEN UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/17/1188 MITTEILUNG 20170601
1910395	300905	Netherlands		PRODUCT NAME: NUSINERSEN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1188 20170601
3449926	2020008	Norway		PRODUCT NAME: NUSINERSEN ELLER SALTER DERAV; REG. NO/DATE: EU/1/17/1188 20170608
2548560	797	Finland

Market Dynamics and Financial Trajectory for Nusinersen Sodium

Last updated: March 20, 2026

What is Nusinersen Sodium?

Nusinersen sodium is an antisense oligonucleotide therapy developed by Biogen for the treatment of spinal muscular atrophy (SMA). Approved by the FDA in December 2016, it is marketed as Spinraza. Nusinersen works by increasing the production of the survival motor neuron (SMN) protein, addressing underlying genetic deficiency.

Market Size and Growth Drivers

Global SMA Treatment Market

The SMA treatment market was valued at approximately $500 million in 2021 and is projected to reach around $2.8 billion by 2030, growing at a compound annual growth rate (CAGR) of 22% (Fortune Business Insights, 2022). Nusinersen's market share is estimated at 55% as of 2023, outpacing competitors such as risdiplam (Evrysdi) and onasemnogene abeparvovec (Zolgensma).

Key Adoption Factors

• Efficacy and Clinical Outcomes: Demonstrates significant improvements in motor function and survival rates.
• Regulatory Approvals: Approved in over 60 countries, expanding global access.
• Pricing and Reimbursement: List price set at approximately $125,000 per injection, with a typical treatment course involving four injections in the first year, totaling $500,000 annually.

Patient Population

The estimated SMA population worldwide is about 30,000. SMA Type I accounts for approximately 60% of cases, primarily affecting infants and young children, representing the core target demographic for Nusinersen.

Revenue and Financial Performance

Sales Performance

• 2020: $862 million (Biogen annual report)
• 2021: $1.05 billion, up 22% YoY
• 2022: $1.28 billion, up 22% YoY

Revenue Breakdown

Year	Total Revenue ($ millions)	Nusinersen Sales ($ millions)	Market Share (%)
2020	13,420	862	6.4%
2021	13,498	1,050	7.8%
2022	13,700	1,280	9.3%

Note: The figures mainly reflect U.S. and European markets, with emerging markets gaining traction.

Cost Structure and R&D

Biogen reports R&D expenditures of approximately $2.3 billion in 2022, with ongoing investment in next-generation antisense therapies and gene therapies targeting SMA.

Competitive Landscape

Major Competitors

• Risdiplam (Evrysdi): Oral administration, approved in 2019, accounts for roughly 30% of the SMA market.
• Onasemnogene Abeparvovec (Zolgensma): Gene therapy approved in 2019, with a one-time dose priced at $2.1 million, capturing approximately 15% of the market.

Market Position and Challenges

Nusinersen maintains the largest share due to early market entry and extensive clinical data. Challenges include competition from newer therapies, pricing pressures, and reimbursement hurdles.

Market Trends and Future Outlook

Patent and Regulatory Landscape

Biogen’s composition patent extends until 2031. Patent cliffs pose minimal short-term threat but necessitate pipeline development.

Pipeline and Lifecycle Management

Investments target gene therapies and RNA-based treatments for SMA and other neurodegenerative conditions. A combination approach could diversify revenue streams.

Pricing Dynamics

Reimbursement negotiations influence overall pricing strategies, with some payers negotiating discounts or expanded coverage for increased access.

Conclusion

Nusinersen sodium remains the dominant SMA treatment, with consistent annual revenue growth driven by expanding global access, new approvals, and increasing diagnosed patient populations. Market competition is intensifying, especially from gene therapies and oral options, requiring ongoing innovation and pricing strategy adjustments.

Key Takeaways

• Nusinersen’s global sales have grown annually, reaching over $1.28 billion in 2022.
• Its market share remains significant despite competition from gene therapies and oral treatments.
• Pricing and reimbursement strategies are critical to sustain revenue growth.
• The SMA treatment market is projected to expand at a CAGR of 22%, reaching nearly $2.8 billion by 2030.
• Biogen continues R&D investments, focusing on pipeline therapies to maintain long-term market relevance.

FAQs

1. What is the primary mechanism of action for Nusinersen?
   It is an antisense oligonucleotide that modulates splicing of the SMN2 gene to increase production of functional SMN protein.

2. How does Nusinersen compare price-wise to its competitors?
   Nusinersen’s list price is approximately $500,000 annually; in contrast, onasemnogene abeparvovec is a one-time $2.1 million therapy, while risdiplam costs about $340,000 annually.

3. What are the main challenges facing Nusinersen’s market growth?
   Competition from gene therapies and oral treatments, reimbursement complexities, and manufacturing costs.

4. Are there upcoming regulatory changes that could impact Nusinersen?
   Potential changes in health policy and pricing regulations in key markets could influence access and reimbursement but no immediate regulatory barriers are anticipated.

5. What is Biogen’s strategy to sustain Nusinersen’s market position?
   Investing in pipeline expansion, diversifying treatment modalities, and engaging reimbursement agencies to expand access.

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References

1. Fortune Business Insights. (2022). SMA Treatment Market Size, Share & Trends. Retrieved from https://www.fortunebusinessinsights.com/
2. Biogen Annual Report 2022. (2022). Retrieved from https://www.biogen.com/
3. U.S. Food and Drug Administration. (2016). FDA approves Spinraza for spinal muscular atrophy. Retrieved from https://www.fda.gov/
4. MarketLine. (2023). SMA therapeutics competitive landscape. Retrieved from https://www.marketline.com/
5. European Medicines Agency. (2017). Spinraza approval details. Retrieved from https://www.ema.europa.eu/