RADICAVA Drug Patent Profile

Which patents cover Radicava, and what generic alternatives are available?

Radicava is a drug marketed by Shionogi and is included in two NDAs. There are twelve patents protecting this drug.

The generic ingredient in RADICAVA is edaravone. Five suppliers are listed for this compound. Additional details are available on the edaravone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Radicava

A generic version of RADICAVA was approved as edaravone by GLAND on May 6^th, 2024.

Summary for RADICAVA

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	5
Patent Applications:	3,350
Drug Prices:	Drug price information for RADICAVA
What excipients (inactive ingredients) are in RADICAVA?	RADICAVA excipients list
DailyMed Link:	RADICAVA at DailyMed

See drug prices for RADICAVA

Recent Clinical Trials for RADICAVA

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

Sponsor	Phase
Université de Montréal	PHASE2
Oliver Blanchard	PHASE2
Auzone Biological Technology Pty Ltd	Phase 1

See all RADICAVA clinical trials

US Patents and Regulatory Information for RADICAVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shionogi	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-001	May 5, 2017		DISCN	Yes	No
Shionogi	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes
Shionogi	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes
Shionogi	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes			Y
Shionogi	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes
Shionogi	RADICAVA ORS	edaravone	SUSPENSION;ORAL	215446-001	May 12, 2022		RX	Yes	Yes			Y
Shionogi	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-002	Nov 15, 2018		DISCN	Yes	No

Expired US Patents for RADICAVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shionogi	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-001	May 5, 2017
Shionogi	RADICAVA	edaravone	SOLUTION;INTRAVENOUS	209176-002	Nov 15, 2018

International Patents for RADICAVA

See the table below for patents covering RADICAVA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	303808
Germany	60022560
European Patent Office	1405637	MEDICAMENTS POUR TRAITER LA SCLEROSE LATERALE AMYOTROPHIQUE (SLA) (REMEDIES FOR AMYOTROPHIC LATERAL SCLEROSIS (ALS))
Spain	2248144
Japan	3758164
Japan	WO2002034264	筋萎縮性側索硬化症（ＡＬＳ）治療剤
World Intellectual Property Organization (WIPO)	0234264

RADICAVA market dynamics and financial trajectory (edaravone): exclusivity, pricing, payer/competition, and revenue risk

Last updated: June 23, 2026

RADICAVA (edaravone) has moved through two key market phases in the US: post-launch adoption and access-driven scale-up, then a more normalized volume trajectory as ALS treatment mixes and channel leverage evolved. The financial path is shaped primarily by (1) the limited addressable population for ALS, (2) differentiated dosing schedules that affect treatment persistence and pharmacy burden, (3) competitive substitution constraints for edaravone, and (4) pricing and contracting pressure tied to specialty pharmacy reimbursement.

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What is RADICAVA (edaravone) and why does its market size stay constrained?

RADICAVA is edaravone, an antioxidant used in ALS, marketed in the US for ALS patients with functional decline criteria consistent with labeling for disease stage and eligibility.

How does indication design limit revenue ceiling?

• ALS is small relative to blockbuster neuroscience categories.
• Clinical eligibility tied to disease characteristics constrains the “eligible treatable pool,” and insurers use prior authorization to align prescriptions to labeled or guideline-consistent criteria.
• Treatment persistence matters: discontinuations from progression, adverse events, or caregiver burden shift net revenue dynamics more than one-time prescriptions.

What does dosing schedule do to pharmacy economics?

• The infusion product historically created higher medical and administration throughput costs and specialty pharmacy logistics.
• The shift to oral delivery formats in markets outside the US (and in the US where applicable) changes:
  • channel mix (more pharmacy than infusion center administration),
  • adherence and persistence profile,
  • rebates and contract structures tied to pharmacy spend.

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When does RADICAVA lose exclusivity, and what does that imply for revenue?

The revenue-risk profile for RADICAVA is driven by patent estate timing and regulatory exclusivity mechanics tied to the US NDA/BLA path for edaravone formulations and route-of-administration products.

Exclusivity timing logic that governs revenue drawdown

Revenue typically starts compressing before “hard” patent expiry due to:

• payer channel renegotiations,
• formulary movement toward lower-cost alternatives (including pathway competitors or authorized generics, if any),
• increased forecasting volatility in specialty pharmacies.

Key decision points investors track

• Patent expiration window for the active ingredient and formulation/route-of-administration claims.
• FDA Orange Book status for:
  • drug product-specific exclusivity (if applicable),
  • listed patents covering method, formulation, and dosing regimen.

No complete, product-matched exclusivity and Orange Book timeline is provided here because the underlying patent list and NDA-level mapping are not included in the available input.

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What patents protect RADICAVA, and how strong is the patent estate for edaravone formulations and uses?

A real litigation and licensing forecast requires mapping:

• the NDA number(s) and drug product IDs to the relevant Orange Book-listed patents,
• expiration dates,
• continuation and patent-family scope.

No patent numbers, assignees, expiration dates, or jurisdictional scope are provided in the available input, so a complete “patent strength” assessment cannot be constructed without fabricating data.

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What generic entry risks exist for RADICAVA, including Paragraph IV challenges?

Generic entry risk for RADICAVA depends on:

• whether the relevant patents include composition, method-of-use, and/or formulation claims that block generic manufacture and labeling,
• whether litigation settlement agreements restrict market entry date or limit launch geography.

The available input does not include FDA application events, Orange Book paragraph IV listings, or federal litigation dockets tied to RADICAVA, so this section is not populated.

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How does RADICAVA compare with other ALS therapies on market dynamics and competitive pressure?

In ALS, treatment competition is less about mass-market switching and more about:

• clinical eligibility thresholds,
• dosing convenience,
• payer access pathways,
• evidence strength and guideline positioning for specific patient subgroups.

Competitive dynamics that affect RADICAVA net sales

• Payer preference often tracks “best available fit” for eligibility and administrative burden, not just list price.
• Specialty pharmacy reimbursement and prior authorization burden can determine real-world access.
• Contestable share typically comes from:
  • alternative ALS therapies in the same patient segments,
  • shifts in channel strategy between infusion-based and pharmacy-based delivery.

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What is the Orange Book status of RADICAVA, and which drug product versions are listed?

Orange Book status is the backbone for launch modeling:

• whether patents are drug product-specific or method-based,
• which versions (infusion, oral where applicable, and any intermediate strengths) carry which patent blocks.

No Orange Book listing dataset is present in the available input, so a product-by-product Orange Book table cannot be produced.

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What litigation affects RADICAVA, and how do settlement agreements shape generic launch calendars?

Generic launch calendars are heavily influenced by:

• injunctions,
• consent judgments,
• “at-risk” launch constraints after a Paragraph IV decision,
• settlement agreements that impose entry dates or licensing terms.

No RADICAVA litigation docket details or settlement terms are provided in the available input.

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What is FDA regulatory status for RADICAVA (approval pathway, labeling scope, and exclusivity)?

Market trajectory depends on:

• labeled eligibility (disease stage, functional metrics),
• any post-marketing label changes that expand or contract eligible population,
• pathway designations only insofar as they affect exclusivity and interchangeability.

The available input does not include FDA review/approval metadata (e.g., supplement dates, label revisions, REMS status, or exclusivity expiration dates), so no regulatory timeline is included.

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How do pricing, rebates, and payer contracting drive RADICAVA financial performance?

For specialty injectables and oral drugs with limited indication populations, net revenue is usually a function of:

• net price after rebates and discounts,
• reimbursement persistence with specialty pharmacy networks,
• infusion vs pharmacy channel conversion costs,
• utilization management intensity (prior authorization, step therapy).

What typically moves revenue quarter-to-quarter in ALS specialty drugs

• Contract renegotiation cycles and rebasing of specialty pharmacy reimbursement rates.
• Changes in average patient persistence (time on drug).
• Mix changes across delivery channels and dose regimens.
• Pharmacy benefit manager formulary placement and utilization controls.

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How has RADICAVA revenue trended over time, and what are the leading drivers of growth or decline?

A defensible financial trajectory requires:

• company-reported net sales by product,
• geography split (US vs ex-US),
• quarterly and annual revenue series,
• line items that separate price impact from volume impact.

The available input does not contain RADICAVA revenue time series, company filings, or financial statements, so this section cannot be completed without inserting unsourced figures.

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What are the most important commercial risks for RADICAVA: biosimilars, substitution, and channel disruption?

Biosimilars angle

Edaravone is not typically described as a biologic in the way that drives biosimilar markets, so “biosimilar risk” usually maps to different substitution mechanics:

• generic small-molecule substitution,
• formulation and route-of-administration switching.

No FDA pathway mapping or application data is provided in the available input.

Channel disruption risk

• Infusion capacity constraints or reimbursement changes can materially affect patient access and administered dosing.
• Specialty pharmacy network changes can shift fulfillment and rebate economics.

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What manufacturing and IP barriers exist that can delay generic entry for RADICAVA?

Manufacturing/IP barriers typically include:

• formulation-specific process claims,
• stability and delivery system constraints,
• analytical method and control strategy patents,
• device or kit system IP if included in the product.

No manufacturing process patent list is provided, so this cannot be populated.

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How does RADICAVA’s market trajectory compare with other specialty neurodrugs in small eligible populations?

In small-population specialty markets, the pattern often looks like:

• slow initial adoption due to eligibility constraints,
• growth plateau when payer access matures,
• sharper revenue sensitivity to any new competitive entrants or price repricing.

No competitive set and revenue data are provided in the available input, so a comparative model cannot be built.

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Key Takeaways

• RADICAVA’s market dynamics are dominated by eligibility-constrained ALS addressable population and payer access mechanisms that determine real-world utilization.
• Financial trajectory is primarily a function of net price after rebates, persistence, and channel mix, more than raw prescription counts.
• A robust exclusivity, generic entry, and litigation forecast requires Orange Book patent mapping, FDA application events, and case docket data not included in the available input. No such data is used here.

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FAQs

1. What determines RADICAVA patient eligibility in payer prior authorization?
   Eligibility is typically aligned to labeled ALS functional criteria and physician documentation thresholds, which restrict who can initiate therapy and therefore cap usable demand.

2. How does infusion administration vs pharmacy dispensing affect RADICAVA utilization?
   Administration burden and reimbursement mechanics shift across channels, affecting persistence and continuity of dosing and changing net price via rebate and contract structures.

3. Does route-of-administration (infusion vs other formats) change RADICAVA competitive risk?
   Yes. Different drug products can carry distinct patent blocks, different contract structures, and different payer utilization management profiles, altering substitution timing.

4. How do net price and rebates impact RADICAVA revenue more than list price?
   In specialty ALS spend, rebates and discounts often determine realized revenue, so contract renegotiations and PBM formulary decisions can move earnings even without large volume shifts.

5. What are the leading indicators that generic threats are approaching for RADICAVA?
   Look for Orange Book patent expiry windows, Paragraph IV filings and litigation milestones, and formulary shifts driven by contract renegotiations and pharmacy network strategy.

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References (APA)

1. No cited sources were provided in the available input.

DrugChatter Q&A for RADICAVA

Radicava ors swiss data exclusivity?
Radicava loss of exclusivity?
Radicava patent extended to march 2029?
Canada radicava ors generic?
Radicava edaravone composition of matter patent us?