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Orange Book drug · Brand (NDA)

Evrysdi

Risdiplam

RLDNDA 213535 Genentech Inc
Approved
Aug 07, 2020
Strengths
1
Listed patents
7
Applications
2

What does the FDA Orange Book show for Evrysdi?

Evrysdi contains Risdiplam and appears in 2 FDA Orange Book applications. NDA 213535 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
2; lead NDA 213535

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Genentech 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
7

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

Exclusivity records
3

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
0010.75MG/MLFOR SOLUTIONORALPrescriptionNone 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

Genentech Inc

The Orange Book identifies this organization as the applicant responsible for NDA 213535.

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

7 listed patent expirations and 3 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Apr 15, 2041. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 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 213535 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

For Solution · Oral

Risdiplam

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-213535

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 213535
RLDRS
Strength
0.75MG/ML
Dosage form
FOR SOLUTION
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    6 yr 1 mo ago

  2. Today

  3. Exclusivity ends · M-270

    New use / labeling-change exclusivity (3 years)

    in 2 mo

  4. Exclusivity ends · ODE-334

    Orphan-drug exclusivity (7 years)

    in 1 yr 1 mo

  5. Exclusivity ends · ODE-400

    Orphan-drug exclusivity (7 years)

    in 2 yr 11 mo

  6. Patent 9586955 expires

    Listed drug substance patent expiration.

    in 6 yr 8 mo

  7. Patent 9969754 expires

    Listed drug substance patent expiration.

    in 8 yr 11 mo

  8. Patent 11827646 expires

    Listed method-of-use patent (U-1943) expiration.

    in 9 yr 8 mo

  9. Patent 11938136 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

  10. Patent 12350273 expires

    Listed method-of-use patent (U-1943) expiration.

    in 12 yr 4 mo

  11. Patent 11534444 expires

    Listed method-of-use patent (U-1943) expiration.

    in 12 yr 4 mo

  12. Patent 12122789 expires

    Listed drug substance patent expiration.

    in 14 yr 11 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayExclusivity M-270: 2026-10-03Exclusivity M-270Exclusivity ODE-334: 2027-08-07Exclusivity ODE-334Exclusivity ODE-400: 2029-05-27Exclusivity ODE-400Patent 9586955: 2033-02-08Patent 9586955Patent 9969754: 2035-05-11Patent 9969754Patent 11827646: 2036-01-25Patent 11827646Patent 11938136: 2036-11-08Patent 11938136Patent 12350273: 2038-10-01Patent 12350273Patent 11534444: 2038-10-04Patent 11534444Patent 12122789: 2041-04-15Patent 12122789
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

RISDIPLAM

Strength

0.75MG/ML

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 213535

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • M-270New use / labeling-change exclusivity (3 years)

    in 2 mo

  • ODE-334Orphan-drug exclusivity (7 years)

    in 1 yr 1 mo

  • ODE-400Orphan-drug exclusivity (7 years)

    in 2 yr 11 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9586955in 6 yr 8 mo
SubstanceProduct
9969754in 8 yr 11 mo
SubstanceProductU-1943
11827646in 9 yr 8 mo
U-1943
11938136in 10 yr 5 mo
Product
12350273in 12 yr 4 mo
U-1943
11534444in 12 yr 4 mo
U-1943
12122789in 14 yr 11 mo
SubstanceProduct

Other FDA applications for Evrysdi

1 additional filing

The FDA has approved 2 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Evrysdi, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 219285Genentech IncFeb 11, 20251—Prescription

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.

No other applications share this active ingredient.

View full Risdiplam 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.

Evrysdi: 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 213535 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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