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Orange Book drug · Brand (NDA)

Radicava Ors

Edaravone

RLDNDA 215446 Shionogi
Approved
May 12, 2022
Strengths
1
Listed patents
12

What does the FDA Orange Book show for Radicava Ors?

Radicava Ors contains Edaravone and is the new drug FDA Orange Book record for NDA 215446. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 215446

New drug application identity from the Orange Book snapshot.

Application holder
Shionogi Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
12

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
1

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001105MG/5MLSUSPENSIONORALPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Shionogi Inc

The Orange Book identifies this organization as the applicant responsible for NDA 215446.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

12 listed patent expirations and 1 exclusivity date remain on or after Jul 26, 2026

The latest future date recorded across those files is Nov 12, 2041. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

6 other ANDAs and 1 other NDA found

4 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 215446 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Suspension · Oral

Edaravone

1 application
Product rows
1
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-215446

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 215446
RLDRS
Strength
105MG/5ML
Dosage form
SUSPENSION
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    4 yr 3 mo ago

  2. Today

  3. Exclusivity ends · ODE-144

    Orphan-drug exclusivity (7 years)

    in 2 yr 10 mo

  4. Patent 10987341 expires

    Listed drug product patent expiration.

    in 13 yr 6 mo

  5. Patent 11241416 expires

    Listed drug product patent expiration.

    in 13 yr 6 mo

  6. Patent 11478450 expires

    Listed method-of-use patent (U-3468) expiration.

    in 13 yr 6 mo

  7. Patent 11826352 expires

    Listed drug product patent expiration.

    in 13 yr 6 mo

  8. Patent 11957660 expires

    Listed drug product patent expiration.

    in 13 yr 6 mo

  9. Patent 12285409 expires

    Listed drug product patent expiration.

    in 13 yr 6 mo

  10. Patent 12599586 expires

    Listed drug product patent expiration.

    in 13 yr 6 mo

  11. Patent 12194025 expires

    Listed method-of-use patent (U-4111) expiration.

    in 15 yr 6 mo

  12. Patent 12310946 expires

    Listed method-of-use patent (U-4111) expiration.

    in 15 yr 6 mo

  13. Patent 12478611 expires

    Listed method-of-use patent (U-4111) expiration.

    in 15 yr 6 mo

  14. Patent 12527769 expires

    Listed method-of-use patent (U-4111) expiration.

    in 15 yr 6 mo

  15. Patent 12569469 expires

    Listed method-of-use patent (U-4111) expiration.

    in 15 yr 6 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayExclusivity ODE-144: 2029-05-12Exclusivity ODE-144Patent 10987341: 2039-11-01Patent 10987341Patent 11241416: 2039-11-01Patent 11241416Patent 11478450: 2039-11-01Patent 11478450Patent 11826352: 2039-11-01Patent 11826352Patent 11957660: 2039-11-01Patent 11957660Patent 12285409: 2039-11-01Patent 12285409Patent 12599586: 2039-11-01Patent 12599586Patent 12194025: 2041-11-12Patent 12194025Patent 12310946: 2041-11-12Patent 12310946Patent 12478611: 2041-11-12Patent 12478611Patent 12527769: 2041-11-12Patent 12527769Patent 12569469: 2041-11-12Patent 12569469
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

EDARAVONE

Strength

105MG/5ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 215446

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • ODE-144Orphan-drug exclusivity (7 years)

    in 2 yr 10 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10987341in 13 yr 6 mo
Product
11241416in 13 yr 6 mo
Product
11478450in 13 yr 6 mo
U-3468
11826352in 13 yr 6 mo
Product
11957660in 13 yr 6 mo
Product
12285409in 13 yr 6 mo
Product
12599586in 13 yr 6 mo
Product
12194025in 15 yr 6 mo
U-4111
12310946in 15 yr 6 mo
U-4111
12478611in 15 yr 6 mo
U-4111
12527769in 15 yr 6 mo
U-4111
12569469in 15 yr 6 mo
U-4111

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Edaravone family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Radicava Ors: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 215446 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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