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Orange Book drug · Brand (NDA)

Ztalmy

Ganaxolone

RLDNDA 215904 Immedica Pharma
Approved
Jun 01, 2022
Strengths
1
Listed patents
11

What does the FDA Orange Book show for Ztalmy?

Ztalmy contains Ganaxolone and is the new drug FDA Orange Book record for NDA 215904. 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 215904

New drug application identity from the Orange Book snapshot.

Application holder
Immedica Pharma Ab

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
11

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
00150MG/MLSUSPENSIONORALPrescriptionNone 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

Immedica Pharma Ab

The Orange Book identifies this organization as the applicant responsible for NDA 215904.

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

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

The latest future date recorded across those files is Sep 30, 2042. 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 215904 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

Ganaxolone

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-215904

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 215904
RLDRS
Strength
50MG/ML
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. Patent 7858609 expires

    Listed drug product patent expiration.

    in 4 mo

  4. Patent 8022054 expires

    Listed drug product patent expiration.

    in 4 mo

  5. Patent 8367651 expires

    Listed drug product patent expiration.

    in 4 mo

  6. Patent 8618087 expires

    Listed method-of-use patent (U-3374) expiration.

    in 4 mo

  7. Patent 9029355 expires

    Listed drug product patent expiration.

    in 4 mo

  8. Patent 9056116 expires

    Listed method-of-use patent (U-3374) expiration.

    in 4 mo

  9. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    in 10 mo

  10. Exclusivity ends · D-197

    New indication / change exclusivity (3 years)

    in 2 yr 3 mo

  11. Exclusivity ends · ODE-395

    Orphan-drug exclusivity (7 years)

    in 2 yr 11 mo

  12. Patent 8318714 expires

    Listed drug product patent expiration.

    in 5 yr 5 mo

  13. Patent 10603308 expires

    Listed method-of-use patent (U-3374) expiration.

    in 11 yr 2 mo

  14. Patent 12144801 expires

    Listed method-of-use patent (U-4034) expiration.

    in 11 yr 2 mo

  15. Patent 12115169 expires

    Listed method-of-use patent (U-3374) expiration.

    in 16 yr 5 mo

  16. Patent 12268696 expires

    Listed method-of-use patent (U-3374) expiration.

    in 16 yr 5 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayPatent 7858609: 2026-11-28Patent 7858609Patent 8022054: 2026-11-28Patent 8022054Patent 8367651: 2026-11-28Patent 8367651Patent 8618087: 2026-11-28Patent 8618087Patent 9029355: 2026-11-28Patent 9029355Patent 9056116: 2026-11-28Patent 9056116Exclusivity NCE: 2027-06-01Exclusivity NCEExclusivity D-197: 2028-10-16Exclusivity D-197Exclusivity ODE-395: 2029-06-01Exclusivity ODE-395Patent 8318714: 2031-11-28Patent 8318714Patent 10603308: 2037-08-10Patent 10603308Patent 12144801: 2037-08-10Patent 12144801Patent 12115169: 2042-09-30Patent 12115169Patent 12268696: 2042-09-30Patent 12268696
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

GANAXOLONE

Strength

50MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 215904

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • NCENew chemical entity exclusivity (5 years)

    in 10 mo

  • D-197New indication / change exclusivity (3 years)

    in 2 yr 3 mo

  • ODE-395Orphan-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
7858609in 4 mo
Product
8022054in 4 mo
Product
8367651in 4 mo
Product
8618087in 4 mo
U-3374
9029355in 4 mo
Product
9056116in 4 mo
U-3374
8318714in 5 yr 5 mo
Product
10603308in 11 yr 2 mo
U-3374
12144801in 11 yr 2 mo
U-4034
12115169in 16 yr 5 mo
U-3374
12268696in 16 yr 5 mo
U-3374

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 Ganaxolone 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.

Ztalmy: 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 215904 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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