Skip to content
Assyro AI
Orange Book drug · Brand (NDA)

Xyrem

Sodium Oxybate

RLDNDA 021196 Jazz Pharms
Approved
Jul 17, 2002
Strengths
1
Listed patents
13

What does the FDA Orange Book show for Xyrem?

Xyrem contains Sodium Oxybate and is the new drug FDA Orange Book record for NDA 021196. 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 021196

New drug application identity from the Orange Book snapshot.

Application holder
Jazz Pharmaceuticals 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
AA

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

Listed patents
13

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

Exclusivity records
2

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
0010.5GM/MLSOLUTIONORALPrescriptionAA
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

Jazz Pharmaceuticals Inc

The Orange Book identifies this organization as the applicant responsible for NDA 021196.

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

TE code AA across rated presentations

An AA code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

13 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Sep 15, 2033. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

3 other ANDAs and 1 other NDA found

2 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 021196 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-021196

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 021196
TE AARLDRS
Strength
0.5GM/ML
Dosage form
SOLUTION
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    24 yr 5 mo ago

  2. Exclusivity ends · ODE-231

    Orphan-drug exclusivity (7 years)

    9 mo ago

  3. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    3 mo ago

  4. Today

  5. Patent 10213400 expires

    Listed method-of-use patent (U-2499) expiration.

    in 6 yr 9 mo

  6. Patent 10864181 expires

    Listed method-of-use patent (U-1532) expiration.

    in 6 yr 9 mo

  7. Patent 11253494 expires

    Listed method-of-use patent (U-3323) expiration.

    in 6 yr 9 mo

  8. Patent 11253494 expires

    Listed method-of-use patent (U-3324) expiration.

    in 6 yr 9 mo

  9. Patent 11986446 expires

    Listed method-of-use patent (U-3324) expiration.

    in 6 yr 9 mo

  10. Patent 8772306 expires

    Listed method-of-use patent (U-1532) expiration.

    in 6 yr 9 mo

  11. Patent 9050302 expires

    Listed method-of-use patent (U-1532) expiration.

    in 6 yr 9 mo

  12. Patent 9486426 expires

    Listed method-of-use patent (U-1532) expiration.

    in 6 yr 9 mo

  13. Patent 10213400*PED expires

    Listed listed patent expiration.

    in 7 yr 3 mo

  14. Patent 10864181*PED expires

    Listed listed patent expiration.

    in 7 yr 3 mo

  15. Patent 11253494*PED expires

    Listed listed patent expiration.

    in 7 yr 3 mo

  16. Patent 8772306*PED expires

    Listed listed patent expiration.

    in 7 yr 3 mo

  17. Patent 9050302*PED expires

    Listed listed patent expiration.

    in 7 yr 3 mo

  18. Patent 9486426*PED expires

    Listed listed patent expiration.

    in 7 yr 3 mo

Patent & exclusivity timeline

Protection horizon
2025202620272028202920302031203220332034TodayExclusivity ODE-231: 2025-10-26Exclusivity ODE-231Exclusivity PED: 2026-04-26Exclusivity PEDPatent 10213400: 2033-03-15Patent 10213400Patent 10864181: 2033-03-15Patent 10864181Patent 11253494: 2033-03-15Patent 11253494Patent 11253494: 2033-03-15Patent 11253494Patent 11986446: 2033-03-15Patent 11986446Patent 8772306: 2033-03-15Patent 8772306Patent 9050302: 2033-03-15Patent 9050302Patent 9486426: 2033-03-15Patent 9486426Patent 10213400*PED: 2033-09-15Patent 10213400*PEDPatent 10864181*PED: 2033-09-15Patent 10864181*PEDPatent 11253494*PED: 2033-09-15Patent 11253494*PEDPatent 8772306*PED: 2033-09-15Patent 8772306*PEDPatent 9050302*PED: 2033-09-15Patent 9050302*PEDPatent 9486426*PED: 2033-09-15Patent 9486426*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

SODIUM OXYBATE

Strength

0.5GM/ML

Dosage form

SOLUTION

Route

ORAL

TE code

AA

Application

NDA 021196

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • ODE-231Orphan-drug exclusivity (7 years)

    9 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    3 mo ago

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10213400in 6 yr 9 mo
U-2499
10864181in 6 yr 9 mo
U-1532
11253494in 6 yr 9 mo
U-3323
11253494in 6 yr 9 mo
U-3324
11986446in 6 yr 9 mo
U-3324
8772306in 6 yr 9 mo
U-1532
9050302in 6 yr 9 mo
U-1532
9486426in 6 yr 9 mo
U-1532
10213400*PEDin 7 yr 3 mo
10864181*PEDin 7 yr 3 mo
11253494*PEDin 7 yr 3 mo
8772306*PEDin 7 yr 3 mo
9050302*PEDin 7 yr 3 mo
9486426*PEDin 7 yr 3 mo

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 Sodium Oxybate 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.

Xyrem: 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 021196 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo