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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 two patent family members in twenty-seven 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.

Indicators of Generic Entry

Summary for SPINRAZA

International Patents:	102
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Drug Prices:	Drug price information 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

Constraining patent/regulatory exclusivity:

8,361,977

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
Winthrop University Hospital	Early Phase 1
NYU Langone Health	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.

This potential generic entry date is based on patent 8,361,977.

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	8,110,560
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	9,926,559
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	8,980,853
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	9,717,750
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	10,266,822
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	8,361,977		Y	Y

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	6,166,197
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016	7,101,993
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016	6,210,892

International Patents for SPINRAZA

When does loss-of-exclusivity occur for SPINRAZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Lithuania

Luxembourg

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Spain	2397113
Hungary	T63650
Hungary	T63430
Canada	2145664	OLIGONUCLEOTIDES AYANT UNE SEQUENCE CENTRALE G4 CONSERVEE (OLIGONUCLEOTIDES HAVING A CONSERVED G4 CORE SEQUENCE)
Hungary	T64474
European Patent Office	1080225

Supplementary Protection Certificates for SPINRAZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2548560	57/2017	Austria		PRODUCT NAME: NUSINERSEN UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/17/1188 MITTEILUNG 20170601
2548560	PA2017037,C2548560	Lithuania		PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530
2548560	PA2017037	Lithuania		PRODUCT NAME: NUSINERSENAS ARBA JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1188/001 20170530
2548560	17C1048	France		PRODUCT NAME: NUSINERSEN OU SES SELS; REGISTRATION NO/DATE: EU/1/17/1188 20170601
2548560	2017C/048	Belgium		PRODUCT NAME: SPINRAZA - NUSINERSEN; AUTHORISATION NUMBER AND DATE: EU/1/17/1188 20170601
2548560	C02548560/01	Switzerland		PRODUCT NAME: NUSINERSEN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66495 20.09.2017

SPINRAZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of SPINRAZA

Introduction to SPINRAZA

SPINRAZA, developed by Biogen and Ionis Pharmaceuticals, is a groundbreaking treatment for Spinal Muscular Atrophy (SMA), a genetic disorder that affects muscle strength and movement. Since its approval, SPINRAZA has been a pivotal player in the SMA treatment market, shaping the landscape with its innovative approach and significant financial impact.

First-Mover Advantage

SPINRAZA was the first FDA-approved treatment for SMA, launching in 2016. This first-mover advantage was crucial, as it generated $884 million in worldwide sales in its first year, a figure that grew to approximately $2.1 billion by 2019[1].

Revenue Performance

The drug's revenue performance has been impressive. As of the end of 2022, SPINRAZA had generated around $10 billion in revenue over its lifetime, making Biogen the revenue leader in the SMA market. This success led to a significant royalty deal, with Ionis receiving $240 million in SPINRAZA royalties in 2023, comparable to the previous year[5].

Quarterly and Annual Sales

In the fourth quarter of 2017, SPINRAZA revenues included $218 million in U.S. sales and $144 million in sales outside the U.S., with key markets being Germany, Turkey, and Japan[3]. This strong performance contributed to Biogen's record revenues for both the full year and the fourth quarter of 2017.

Market Expansion and Competition

The SMA market has expanded significantly with the introduction of new therapeutic modalities. Despite SPINRAZA's dominance, newer treatments like Zolgensma and Evrysdi have entered the market, offering different benefits such as better long-term efficacy and convenience of dosing. Zolgensma, despite its high cost and access challenges, has become a blockbuster, while Evrysdi has quickly gained market traction due to its ease of administration[1].

Market Growth

The total SMA market has grown substantially, increasing by nearly 50% in just two years from $3.0 billion in 2020 to $4.4 billion in 2022. This growth is attributed to the increased availability of treatments, allowing more patients to access care[1].

Financial Highlights

Ionis Pharmaceuticals' Financials

Ionis Pharmaceuticals, the partner in the development of SPINRAZA, has seen consistent revenue from royalties. In the second quarter of 2023, Ionis reported $61 million in SPINRAZA royalties, with a total of $111 million for the first half of the year. For the full year 2023, Ionis received $240 million from SPINRAZA royalties, which was comparable to the previous year[2][5].

Biogen's Financials

Biogen's financial performance has been significantly boosted by SPINRAZA. The drug's launch drove full-year revenue growth for Biogen in 2017. The company reported $363 million in SPINRAZA revenues for the full year 2017, with U.S. sales of $218 million and international sales of $144 million in the fourth quarter alone[3].

Challenges and Opportunities

Patient Access and Cost

Despite its success, SPINRAZA faces challenges related to patient access and high costs. However, favorable reimbursement policies have supported its widespread adoption. Newer treatments, while also expensive, offer different value propositions that are attracting patients and healthcare providers[1][4].

Emerging Therapeutic Modalities

The advancement of new therapeutic modalities is a double-edged sword. While it expands the market and offers more treatment options, it also introduces competition. Companies and investors must navigate this complex landscape by identifying new and better targets to pursue and understanding the context-dependent nature of market dynamics[1].

Future Outlook

Market Projections

The SMA market is expected to continue growing, driven by advancements in gene therapy and the increasing availability of targeted treatments. The market size is projected to reach $13.0 billion by 2034, exhibiting a CAGR of 14.28% during 2024-2034[4].

Competitive Landscape

The competitive landscape will remain dynamic, with new entrants and existing players vying for market share. The ease of administration, long-term efficacy, and cost will be key factors influencing market share. Companies must innovate and adapt to these changing market conditions to remain competitive[1].

Key Takeaways

• First-Mover Advantage: SPINRAZA's early market entry was crucial for its success.
• Revenue Performance: The drug has generated over $10 billion in revenue since its launch.
• Market Expansion: The SMA market has grown significantly with the introduction of new treatments.
• Competition: New treatments like Zolgensma and Evrysdi are gaining market share.
• Financial Impact: SPINRAZA has been a significant revenue driver for both Biogen and Ionis Pharmaceuticals.
• Future Outlook: The SMA market is expected to grow, driven by advancements in gene therapy and new treatments.

FAQs

What was the initial revenue generated by SPINRAZA in its first year?

SPINRAZA generated $884 million in worldwide sales in its first year after launch.

How much revenue has SPINRAZA generated over its lifetime as of 2022?

As of the end of 2022, SPINRAZA had generated approximately $10 billion in revenue over its lifetime.

What are the key factors influencing the market share of SMA treatments?

The key factors include ease of administration, long-term efficacy, and cost.

How is the SMA market expected to grow in the future?

The SMA market is projected to reach $13.0 billion by 2034, exhibiting a CAGR of 14.28% during 2024-2034.

What challenges does SPINRAZA face despite its success?

SPINRAZA faces challenges related to patient access and high costs, although favorable reimbursement policies have supported its adoption.

Sources

1. Outclassed: The Battle for Therapeutic Market Share - a16z.com
2. Ionis reports second quarter 2023 financial results - PR Newswire
3. Biogen Reports Record Revenues for Both the Full Year and Fourth Quarter - Biogen Investors
4. Spinal Muscular Atrophy Market Size to Reach US$ 13.0 Billion by 2034 - Biospace
5. Ionis reports fourth quarter and full year 2023 financial results - Ionis IR