EVRYSDI Drug Patent Profile

When do Evrysdi patents expire, and what generic alternatives are available?

Evrysdi is a drug marketed by Genentech Inc and is included in two NDAs. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-six patent family members in thirty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Evrysdi

Evrysdi was eligible for patent challenges on August 7, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 15, 2041. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for EVRYSDI

International Patents:	166
US Patents:	7
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	3
Patent Applications:	151
Drug Prices:	Drug price information for EVRYSDI
What excipients (inactive ingredients) are in EVRYSDI?	EVRYSDI excipients list
DailyMed Link:	EVRYSDI at DailyMed

See drug prices for EVRYSDI

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

Constraining patent/regulatory exclusivity:

12,122,789

NDA:

213535

Dosage:

FOR SOLUTION;ORAL

Constraining patent/regulatory exclusivity:

12,122,789

NDA:

219285

Dosage:

TABLET;ORAL

^*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 EVRYSDI

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

Sponsor	Phase
Hoffmann-La Roche	Phase 4
Genentech, Inc.	Phase 4
Hoffmann-La Roche	Phase 1

See all EVRYSDI clinical trials

Pharmacology for EVRYSDI

Drug Class	Survival of Motor Neuron 2 Splicing Modifier
Mechanism of Action	Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors Survival of Motor Neuron 2 Splicing Modifiers
Physiological Effect	Increased Protein Synthesis

Paragraph IV (Patent) Challenges for EVRYSDI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EVRYSDI	For Oral Solution	risdiplam	0.75 mg/mL	213535	2	2024-08-07

US Patents and Regulatory Information for EVRYSDI

EVRYSDI is protected by seven US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 12,122,789.

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
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535-001	Aug 7, 2020		RX	Yes	Yes	11,827,646
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535-001	Aug 7, 2020		RX	Yes	Yes	9,586,955		Y	Y
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535-001	Aug 7, 2020		RX	Yes	Yes	9,969,754		Y	Y
Genentech Inc	EVRYSDI	risdiplam	TABLET;ORAL	219285-001	Feb 11, 2025		RX	Yes	Yes	11,534,444

EU/EMA Drug Approvals for EVRYSDI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Evrysdi	risdiplam	EMEA/H/C/005145Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.	Authorised	no	no	no	2021-03-26

International Patents for EVRYSDI

When does loss-of-exclusivity occur for EVRYSDI?

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

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

South Korea

Taiwan

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 EVRYSDI around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112016026205
Brazil	112018009281
Canada	3078137
China	108299314	用于治疗脊髓性肌萎缩的化合物 (Compounds for treating spinal muscular atrophy)

Supplementary Protection Certificates for EVRYSDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3143025	CA 2021 00037	Denmark		PRODUCT NAME: RISDIPLAM ELLER FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/21/1531 20210329
3143025	C202130047	Spain		PRODUCT NAME: RISDIPLAM O SUS SALES FARMACEUTICAMENTE ACEPTABLES; NATIONAL AUTHORISATION NUMBER: EU/1/21/1531; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1531; DATE OF FIRST AUTHORISATION IN EEA: 20210326
3143025	C03143025/01	Switzerland		PRODUCT NAME: RISDIPLAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67251 06.05.2021
3143025	132021000000149	Italy		PRODUCT NAME: RISDIPLAM O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(EVRYSDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1531, 20210329

Market Dynamics and Financial Trajectory for Evrysdi

Last updated: February 19, 2026

What is Evrysdi and Its Approved Indications?

Evrysdi (risdiplam) is an oral splicing modifier approved by the U.S. Food and Drug Administration (FDA) in August 2020 for the treatment of spinal muscular atrophy (SMA) in patients two months and older.[1] It is developed by Roche and Genentech.

Market Size and Growth Drivers

SMA Market

The global SMA market was valued at approximately USD 1.2 billion in 2022 and is projected to reach USD 3.5 billion by 2028, growing at a compound annual growth rate (CAGR) of 19.5%.[2] Key factors include:

• Increased diagnosis rates due to improved genetic testing.
• Growing adoption of disease-modifying therapies.
• Expanding indications for existing treatments.

Competitor Landscape

Evrysdi competes primarily with:

• Spinraza (nusinersen): FDA-approved since 2016, administered via intrathecal injection.
• Zolgensma (onasemnogene abeparvovec): Gene therapy approved in 2019, administered as a one-time infusion.

In 2022, Spinraza generated USD 1.3 billion globally, Zolgensma about USD 1 billion, indicating high competition.[3]

Market Penetration and Adoption

Evrysdi's oral administration complements existing therapies, facilitating greater penetration:

• Easier to administer in infants and adults.
• Suitable for long-term treatment adherence.
• Significant uptake in North American and European markets, where SMA diagnosis and therapy access are established.

Revenue and Financial Performance

Sales Data

In Roche's 2022 annual report, Evrysdi revenue was USD 472 million, representing a 20% increase over 2021, reflecting early market adoption and expansion into new geographies.[4]

Cost Structure and Pricing

• Average wholesale price (AWP) per year ranges between USD 350,000 to USD 450,000, varying by country and patient weight.
• Payer negotiations impact net pricing; reimbursement processes influence market access.

R&D Investment

Roche and Genentech invested over USD 200 million in clinical development and commercialization efforts for Evrysdi by 2022.[5]

Regulatory and Market Expansion

Global Approvals

• Approved in over 50 countries, including Europe, Canada, and Japan.
• Ongoing applications in other emerging markets.

New Indications and Formulations

• Clinical trials for SMA type 0 and 1 are in advanced phases.
• Pediatric and adult indications are expanding, supporting ongoing revenue growth.

Challenges and Risks

• Pricing pressures: Managed access schemes and cost containment measures threaten margins.
• Market competition: Spinraza's long-term presence and Zolgensma's one-time dosing model sustain price competition.
• Manufacturing costs: Ensure supply chain efficiency to maintain profitability.
• Regulatory delays: Especially in emerging markets, can impede expansion.

Future Financial Trajectory

Revenue Projections

• Expected compound annual growth of 15-20% from 2023 to 2028, driven by expanding indications and geographies.[6]
• Potential for USD 1 billion revenue milestone by 2025.

Key Catalysts

• Regulatory approval in China.
• Positive results from ongoing clinical trials.
• Price negotiations leading to broader reimbursement.

Summary Table: Evrysdi Market Metrics (2022-2028)

Metric	2022	2025 (Projected)	2028 (Projected)
Global SMA Market Size (USD)	USD 1.2 billion	USD 2.3 billion	USD 3.5 billion
Evrysdi Revenue (USD)	USD 472 million	USD 700 million	USD 1 billion
CAGR of Revenue	20%	17%	15%
Market Share in SMA Market	Approx. 40% (by 2022)	50%	55%

---

Key Takeaways

• Evrysdi has established itself as a significant SMA therapy, with a growing revenue base driven by global approvals and expanding indications.
• The market remains highly competitive, with Spinraza and Zolgensma historically leading.
• High pricing, reimbursement negotiations, and market access will shape future financial performance.
• Revenue growth hinges on clinical trial results, regulatory approvals, and market expansion strategies.

FAQs

1. How does Evrysdi differ from Spinraza and Zolgensma?
Evrysdi is orally administered, unlike Spinraza (intrathecal injection) and Zolgensma (single-dose gene therapy). Its ease of use expands treatment accessibility, especially in home settings.

2. What factors influence Evrysdi’s pricing strategy?
Pricing is affected by manufacturing costs, competitive positioning, healthcare system reimbursement policies, and negotiated discounts.

3. What is the potential for Evrysdi in adult SMA patients?
Clinical trials show promise for broader adult indications, which could significantly expand the market but remain under regulatory review.

4. How might emerging markets impact Evrysdi’s revenues?
Market access in countries like China and India offers growth opportunities but depends on approval timelines and pricing negotiations.

5. What are the key risks for investors considering Evrysdi’s market outlook?
Regulatory delays, competitive pressure, pricing constraints, and manufacturing challenges pose risks to sustained revenue growth.

---

References

[1] FDA. (2020). FDA approves Evrysdi to treat spinal muscular atrophy in patients two months of age and older.
[2] MarketsandMarkets. (2023). SMA Market by Type, Treatment, and Geography.
[3] Roche. (2022). Annual Report.
[4] Roche. (2022). Financial Highlights.
[5] Roche. (2022). R&D Investment Details.
[6] Evaluate Pharma. (2023). SMA Drug Market Outlook.