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Orange Book drug · Brand (NDA)

Spinraza

Nusinersen Sodium

RLDNDA 209531 3 strengths Biogen
Approved
Dec 23, 2016
Strengths
3
Listed patents
7

What does the FDA Orange Book show for Spinraza?

Spinraza contains Nusinersen Sodium and is the new drug FDA Orange Book record for NDA 209531. The application has 3 presentations 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 209531

New drug application identity from the Orange Book snapshot.

Application holder
Biogen Inc

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

Product presentations
3

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
0

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
001EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)SOLUTIONINTRATHECALPrescriptionNone posted
RLDRS
002EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)SOLUTIONINTRATHECALPrescriptionNone posted
RLDRS
003EQ 50MG BASE/5ML (EQ 10MG BASE/ML)SOLUTIONINTRATHECALPrescriptionNone 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

Biogen Inc

The Orange Book identifies this organization as the applicant responsible for NDA 209531.

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

3 presentations 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 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Mar 04, 2036. 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 209531 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Intrathecal

Nusinersen Sodium

1 application
Product rows
3
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-209531

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.

Strengths & dosage forms

3 approved presentations · NDA 209531
RLDRS
Strength
EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)
Dosage form
SOLUTION
Route
INTRATHECAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    9 yr 9 mo ago

  2. Today

  3. Patent 7838657 expires

    Listed drug substance patent expiration.

    in 1 yr

  4. Patent 9717750 expires

    Listed method-of-use patent (U-1942) expiration.

    in 3 yr 11 mo

  5. Patent 9717750 expires

    Listed method-of-use patent (U-2094) expiration.

    in 3 yr 11 mo

  6. Patent 9717750 expires

    Listed method-of-use patent (U-2093) expiration.

    in 3 yr 11 mo

  7. Patent 9717750 expires

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

    in 3 yr 11 mo

  8. Patent 8980853 expires

    Listed method-of-use patent (U-1941) expiration.

    in 4 yr 5 mo

  9. Patent 8361977 expires

    Listed drug substance patent expiration.

    in 4 yr 6 mo

  10. Patent 9926559 expires

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

    in 7 yr 7 mo

  11. Patent 10436802 expires

    Listed method-of-use patent (U-2094) expiration.

    in 9 yr 3 mo

  12. Patent 10436802 expires

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

    in 9 yr 3 mo

  13. Patent 10436802 expires

    Listed method-of-use patent (U-1941) expiration.

    in 9 yr 3 mo

  14. Patent 10436802 expires

    Listed method-of-use patent (U-2093) expiration.

    in 9 yr 3 mo

  15. Patent 10436802 expires

    Listed method-of-use patent (U-1944) expiration.

    in 9 yr 3 mo

  16. Patent 10436802 expires

    Listed method-of-use patent (U-1942) expiration.

    in 9 yr 3 mo

  17. Patent 12013403 expires

    Listed method-of-use patent (U-1941) expiration.

    in 9 yr 9 mo

  18. Patent 12013403 expires

    Listed method-of-use patent (U-1942) expiration.

    in 9 yr 9 mo

  19. Patent 12013403 expires

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

    in 9 yr 9 mo

  20. Patent 12013403 expires

    Listed method-of-use patent (U-1944) expiration.

    in 9 yr 9 mo

  21. Patent 12013403 expires

    Listed method-of-use patent (U-2093) expiration.

    in 9 yr 9 mo

  22. Patent 12013403 expires

    Listed method-of-use patent (U-2094) expiration.

    in 9 yr 9 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036TodayPatent 7838657: 2027-07-11Patent 7838657Patent 9717750: 2030-06-17Patent 9717750Patent 9717750: 2030-06-17Patent 9717750Patent 9717750: 2030-06-17Patent 9717750Patent 9717750: 2030-06-17Patent 9717750Patent 8980853: 2030-11-24Patent 8980853Patent 8361977: 2030-12-23Patent 8361977Patent 9926559: 2034-01-09Patent 9926559Patent 10436802: 2035-09-11Patent 10436802Patent 10436802: 2035-09-11Patent 10436802Patent 10436802: 2035-09-11Patent 10436802Patent 10436802: 2035-09-11Patent 10436802Patent 10436802: 2035-09-11Patent 10436802Patent 10436802: 2035-09-11Patent 10436802Patent 12013403: 2036-03-04Patent 12013403Patent 12013403: 2036-03-04Patent 12013403Patent 12013403: 2036-03-04Patent 12013403Patent 12013403: 2036-03-04Patent 12013403Patent 12013403: 2036-03-04Patent 12013403Patent 12013403: 2036-03-04Patent 12013403
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

NUSINERSEN SODIUM

Strength

EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)

Dosage form

SOLUTION

Route

INTRATHECAL

TE code

Not listed

Application

NDA 209531

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7838657in 1 yr
Substance
9717750in 3 yr 11 mo
U-1942
9717750in 3 yr 11 mo
U-2094
9717750in 3 yr 11 mo
U-2093
9717750in 3 yr 11 mo
U-1943
8980853in 4 yr 5 mo
U-1941
8361977in 4 yr 6 mo
SubstanceProduct
9926559in 7 yr 7 mo
U-1943
10436802in 9 yr 3 mo
U-2094
10436802in 9 yr 3 mo
U-1943
10436802in 9 yr 3 mo
U-1941
10436802in 9 yr 3 mo
U-2093
10436802in 9 yr 3 mo
U-1944
10436802in 9 yr 3 mo
U-1942
12013403in 9 yr 9 mo
U-1941
12013403in 9 yr 9 mo
U-1942
12013403in 9 yr 9 mo
U-1943
12013403in 9 yr 9 mo
U-1944
12013403in 9 yr 9 mo
U-2093
12013403in 9 yr 9 mo
U-2094

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 Nusinersen Sodium 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.

Spinraza: 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 209531 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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