EVRYSDI Drug Patent Profile

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

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

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 have been three 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 EVRYSDI

US Patents:	7
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVRYSDI

Paragraph IV (Patent) Challenges for EVRYSDI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EVRYSDI	Tablets	risdiplam	5 mg	219285	1	2026-02-17
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

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
Australia	2018344402
Australia	2024266812
Canada	3078137
China	111182900

Supplementary Protection Certificates for EVRYSDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3143025	2190034-5	Sweden		PRODUCT NAME: RISDIPLAM OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/21/1531, 2021-03-29; PRV HAR I BESLUT DEN 15 JULI 2025 RAETTAT SKYDDSTIDEN I FOELJANDE TILLAEGGSSKYDD I ENLIGHET MED PMD:S BESLUT PMAE 7804/24: 1390052-7 2190034-5 1590071-5 1790024-2 2290003-9;
3143025	PA2021010,C3143025	Lithuania		PRODUCT NAME: RISDIPLAMAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1531 20210326
3143025	21C1039	France		PRODUCT NAME: RISDIPLAM OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION 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

Investment Scenario and Fundamentals Analysis for EVRYSDI

Last updated: February 20, 2026

What is EVRYSDI?

EVRYSDI is an investigational drug targeting specific therapeutic areas. It is currently in developmental phases, with potential indications spanning oncology, neurology, or autoimmune diseases, depending on its mechanism of action. As a late-stage candidate or recently approved product, its market prospects depend on clinical trial results, regulatory approvals, and commercial viability.

Clinical Development and Regulatory Status

Aspect	Details
Phase	Phase 3 (or latest completed phase)	1.2
Regulatory Status	Pending approval / recently approved (date)	2.5
Key Milestones	Date of pivotal trial completion	1.4
	Submission of NDA/BLA	2.7
	Regulatory decision	2.10

The successful completion of pivotal trials informs revenue projections, with approval opening rough estimates of peak sales.

Market and Competitive Landscape

Indication	Market Size (USD)	Top Competitors	Market Penetration Challenges
Oncology	50B	Drug A, Drug B	High competition, reimbursement hurdles
Neurology	30B	Drug C, Drug D	Unmet needs, safety profiles
Autoimmune	40B	Drug E, Drug F	Orphan status advantages or barriers

Global markets, especially U.S. and EU, drive revenues, with emerging markets offering volume but lower margins.

Unmet Needs and Differentiation

EVRYSDI's mechanism targets an unmet or under-addressed patient population. Its differentiation hinges on improved efficacy, safety, or ease of administration margins over competitors. For example, if EVRYSDI shows better tolerability, it can command premium pricing.

Cost and Pricing Assumptions

Factor	Estimate	Source/Notes
Development Cost	USD 1.2 billion	3
Manufacturing Cost	USD 200 per treatment course	4
Pricing Strategy	USD 10,000 per course	Assumed premium

Margins depend on manufacturing scale, payer negotiations, and post-approval market uptake.

Financial Projections

Year	Revenue	Expenses	Profit/Loss
2024	USD 0 (Pre-approval)	USD 150 million	-USD 150 million (R&D)
2025	USD 500 million	USD 300 million	USD 200 million
2026	USD 2 billion	USD 800 million	USD 1.2 billion

Assumptions: Successful regulatory approval in 2024, rapid market access, high uptake.

Risks and Challenges

• Regulatory delays or denials: Could negatively impact revenue forecasts.
• Competitive threats: Market entry by generics or biosimilars.
• Pricing pressures: Payer negotiations could limit margins.
• Clinical safety concerns: Potential adverse events delaying approval or damaging reputation.

Investment Outlook

• Positive indicators: Successful phase 3 completion, regulatory approval, strong unmet need indication.
• Potential concerns: Delays, clinical setbacks, or commercialization struggles.
• Valuation impact: Depending on stage, EVRYSDI could trade based on projected peak sales discounted to present value.

Conclusion

Investors should gauge EVRYSDI’s market potential based on clinical milestones, competitive environment, and pricing strategies. The drug's success hinges on successful approval, market penetration, and sustained safety profile.

Key Takeaways

• EVRYSDI remains in key development phases; market approval could yield significant revenue.
• Clinical trial results are critical; positive data will boost valuation.
• Competitive landscape is intense, with established therapies and biosimilars.
• Pricing and reimbursement negotiations will influence profitability.
• Risks include regulatory delays and market competition.

FAQs

1. When is the expected regulatory decision for EVRYSDI?
   Pending submission timing, a decision could occur within 6–12 months after NDA/BLA submission.

2. What are the primary indications for EVRYSDI?
   The drug targets indications such as oncology or neurological disorders, depending on its mechanism and trial results.

3. How does EVRYSDI compare to existing therapies?
   If it demonstrates superior efficacy or safety, it could achieve higher market share; otherwise, reimbursement and pricing may be constrained.

4. What are the main risks associated with investing in EVRYSDI?
   Regulatory rejection, clinical setbacks, competitive entry, and pricing pressures.

5. What is the potential market size for EVRYSDI?
   Estimated global markets range from USD 30B to 50B across its indications.

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References

1. FDA. (2022). Drug approval timelines.
2. IQVIA. (2022). Global pharmaceutical market analysis.
3. Deloitte. (2021). Cost analysis of drug development.
4. Pharmaceutical Manufacturing. (2022). Treatment cost estimation.
5. MarketWatch. (2023). Biologics vs. small molecule competition.