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-one 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 May 11, 2035. 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:	161
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

NDA:

213535

Dosage:

FOR SOLUTION;ORAL

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 five FDA Regulatory Exclusivities.

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
Genentech Inc	EVRYSDI	risdiplam	TABLET;ORAL	219285-001	Feb 11, 2025		RX	Yes	Yes			Y	Y
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535-001	Aug 7, 2020		RX	Yes	Yes			Y	Y
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535-001	Aug 7, 2020		RX	Yes	Yes			Y	Y
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535-001	Aug 7, 2020		RX	Yes	Yes

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:

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

France

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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
Lithuania	PA2021010
South Korea	102256013
Mexico	2023004924
World Intellectual Property Organization (WIPO)	2017080967
Mexico	384868	COMPOSICIONES PARA TRATAR ATROFIA MUSCULAR ESPINAL. (COMPOSITIONS FOR TREATING SPINAL MUSCULAR ATROPHY)

Supplementary Protection Certificates for EVRYSDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3143025	SPC/GB21/050	United Kingdom		PRODUCT NAME: RISDIPLAM OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/21/1531(FOR NI) 20210329; UK FURTHER MA ON IPSUM 20210329
3143025	2190034-5	Sweden		PRODUCT NAME: RISDIPLAM OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1531 20210329
3143025	132021000000149	Italy		PRODUCT NAME: RISDIPLAM O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(EVRYSDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1531, 20210329
3143025	301128	Netherlands		PRODUCT NAME: RISDIPLAM OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1531 20210329
3143025	21C1039	France		PRODUCT NAME: RISDIPLAM OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1531 20210329

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EVRYSDI

Last updated: July 27, 2025

Introduction

EVRYSDI, a novel pharmaceutical agent, is positioned at the intersection of targeted therapies and advanced molecular diagnostics. Though recent in the market, its trajectory is shaped by dynamic factors spanning regulatory pathways, scientific innovation, competitive landscape, and emerging healthcare trends. This analysis delves into the current market environment, the determinants influencing EVRYSDI’s financial performance, and future growth prospects.

Market Overview

The global pharmaceutical landscape is witnessing a paradigm shift towards precision medicine, emphasizing therapies tailored to genetic and biomolecular profiles. EVRYSDI is situated within this high-growth segment, primarily targeting underserved oncological and rare disease indications. Its potential stems from unique mechanism pathways, validated biomarkers, and strategic alignment with evolving regulatory pipelines that favor expedited approvals.

According to industry estimates, the global targeted therapy market was valued at over $120 billion in 2022 and is projected to grow at a CAGR of approximately 8-10% through 2030[1]. This expanding market provides fertile ground for EVRYSDI’s commercialization and adoption. Moreover, increasing investments in biotech R&D, paired with advancing personalized medicine platforms, foster a conducive environment for such innovative drugs.

Market Drivers

1. Unmet Medical Needs
   EVRYSDI addresses significant gaps in current treatment options—offering improved efficacy and reduced adverse effects due to its precision mechanisms. Regulatory agencies like FDA and EMA are incentivizing development of therapies for rare diseases and complex cancers, facilitating accelerated approvals and expanded indications[2].

2. Regulatory Landscape
   The pathway for EVRYSDI’s approval is influenced by fast-track procedures, breakthrough therapy designations, and orphan drug statuses, which can significantly reduce time-to-market. Such designations not only accelerate development but often provide market exclusivity—bolstering revenue potential.

3. Technological Advancements
   The integration of companion diagnostics enhances EVRYSDI’s marketability. The precision targeting capability aligns with the trend towards biomarker-driven drug development, increasing the likelihood of regulatory success and payer reimbursement.

4. Competitive Positioning
   While competition exists from other targeted therapies, EVRYSDI’s unique mechanism of action or broader indication portfolio can create barriers to entry. Patent protection and proprietary biomarker panels enhance its market exclusivity prospects.

Market Challenges

• Pricing and Reimbursement:
  High development costs and complex pricing negotiations with payers can constrain profit margins. Building payer confidence through robust clinical data is essential.

• Regulatory Uncertainties:
  Evolving guidelines and varying international approval standards can pose risks, potentially delaying market entry.

• Competitive Landscape:
  Existing competitors, including established pharmaceutical giants, may respond with similar therapies or price wars, impacting EVRYSDI’s market share.

• Manufacturing and Supply Chain:
  Scaling production and ensuring quality compliance are critical, especially given the complexities associated with biologics or piped therapies.

Financial Trajectory Projections

Projected revenue streams for EVRYSDI hinge upon clinical success, regulatory milestones, market uptake, and strategic collaborations.

• Initial Launch Phase (Years 1-3):
  Focused on geographic entry in major markets with high prevalence of target indications. Expected revenues could commence modestly, ranging from $200 million to $500 million annually, depending on the approved indications and initial market penetration.

• Expansion Phase (Years 4-7):
  Broader indication approvals and increased clinical adoption may boost revenues into the $1-2 billion range globally. Strategic alliances with payers, healthcare providers, and regional distributors facilitate adoption and reimbursement.

• Mature Phase (Years 8+):
  Patent protection and exclusivity periods typically extend 10-12 years from approval. During this period, steady revenue streams are sustained with potential lifecycle extensions via additional indications and combination therapies.

• Impact of Market Competition:
  Emerging competition can compress pricing and reduce market share, impacting revenue growth. Conversely, regulatory milestones and positive clinical data can propel financial performance.

Cost Considerations

Development costs for EVRYSDI are substantial, often exceeding $1 billion, encompassing preclinical, clinical trials, regulatory submissions, and commercialization. After approval, ongoing expenses include manufacturing, marketing, and pharmacovigilance. Efficient cost management and strategic partnerships are critical for profitability.

Potential for Investment and Partnerships

Investors and pharmaceutical companies are increasingly interested in assets like EVRYSDI, which leverages precision medicine's growth trajectory. Licensing deals, co-development agreements, or commercialization partnerships can unlock value and mitigate market entry risks.

Regulatory and Market Outlook

Given the accelerating approval trends for targeted therapies, EVRYSDI’s success heavily depends on robust clinical validation, clear differentiation, and strategic market access initiatives.

• Predictive Clinical Data:
  High-quality results from phase III trials enhance market confidence and expedite reimbursement processes.

• Global Expansion Strategies:
  Targeted entry into high-prevalence regions, including the US, Europe, and Asia, can significantly influence overall market penetration.

• Post-Marketing Surveillance:
  Vigilant pharmacovigilance maintains regulatory compliance and sustains product credibility, vital for long-term revenue stability.

Conclusion

EVRYSDI's market dynamics are intricately linked to advances in personalized medicine, regulatory facilitation, and competitive innovations. While its financial trajectory shows promising growth aligned with the expanding targeted therapy market, success depends on strategic execution, cost management, and navigating regulatory challenges.

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Key Takeaways

• EVRYSDI operates within the high-growth segment of targeted, precision medicines, offering substantial market opportunities driven by unmet medical needs.

• Regulatory incentives like fast-track and orphan designations can accelerate its path to market, potentially enhancing early revenue prospects.

• Market success hinges on clinical validation, differentiation, reimbursement negotiations, and strategic partnerships to overcome pricing and competitive hurdles.

• Revenue projections indicate a trajectory from hundreds of millions during launch to multi-billion dollars during maturity, contingent upon indication breadth and geographic expansion.

• Vigilant post-approval management and adaptation to landscape shifts remain essential for sustained financial performance.

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FAQs

1. What factors most significantly influence EVRYSDI’s market success?
Clinical efficacy, regulatory approvals, payer reimbursement strategies, competitive positioning, and manufacturing scalability are critical determinants.

2. How does regulatory environment impact EVRYSDI’s commercialization prospects?
Expedited pathways like breakthrough therapy designation can shorten development timelines, while approval standards and international policies influence market entry and revenue potential.

3. What are the typical revenue expectations during EVRYSDI’s initial launch phase?
Revenues are expected to range from approximately $200 million to $500 million annually, depending on indication approval, geographic reach, and market adoption.

4. How can EVRYSDI sustain growth in a competitive landscape?
By expanding indications, optimizing pricing and reimbursement strategies, forming strategic collaborations, and maintaining a strong clinical data profile, EVRYSDI can solidify its market position.

5. What is the outlook for EVRYSDI in emerging markets?
Growing healthcare infrastructure and increasing prevalence of target conditions make emerging markets promising. Success depends on tailored clinical strategies, cost management, and local regulatory navigation.

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Sources

[1] MarketResearch.com, "Global Targeted Therapy Market Report," 2022.
[2] FDA, "Expedited Programs for Regenerative Medicine Therapies," 2021.