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

Ravicti

Glycerol Phenylbutyrate

RLDNDA 203284 Horizon Therap US
Approved
Feb 01, 2013
Strengths
1
Listed patents
15

What does the FDA Orange Book show for Ravicti?

Ravicti contains Glycerol Phenylbutyrate and is the new drug FDA Orange Book record for NDA 203284. 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 203284

New drug application identity from the Orange Book snapshot.

Application holder
Horizon Therapeutics US Holding LLC

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
15

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
0011.1GM/MLLIQUIDORALPrescriptionAA
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

Horizon Therapeutics US Holding LLC

The Orange Book identifies this organization as the applicant responsible for NDA 203284.

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

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

The latest future date recorded across those files is Mar 09, 2032. 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 0 other NDAs found

6 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 203284 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-203284

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 203284
TE AARLDRS
Strength
1.1GM/ML
Dosage form
LIQUID
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    13 yr 8 mo ago

  2. Today

  3. Patent 10045958 expires

    Listed method-of-use patent (U-1816) expiration.

    in 4 yr 3 mo

  4. Patent 10045959 expires

    Listed method-of-use patent (U-1816) expiration.

    in 4 yr 3 mo

  5. Patent 10183002 expires

    Listed method-of-use patent (U-1816) expiration.

    in 4 yr 3 mo

  6. Patent 10183003 expires

    Listed method-of-use patent (U-1816) expiration.

    in 4 yr 3 mo

  7. Patent 10183004 expires

    Listed method-of-use patent (U-1816) expiration.

    in 4 yr 3 mo

  8. Patent 10183005 expires

    Listed method-of-use patent (U-1816) expiration.

    in 4 yr 3 mo

  9. Patent 10183006 expires

    Listed method-of-use patent (U-1816) expiration.

    in 4 yr 3 mo

  10. Patent 10668040 expires

    Listed method-of-use patent (U-1816) expiration.

    in 4 yr 3 mo

  11. Patent 8642012 expires

    Listed method-of-use patent (U-1383) expiration.

    in 4 yr 3 mo

  12. Patent 9254278 expires

    Listed method-of-use patent (U-1816) expiration.

    in 4 yr 3 mo

  13. Patent 9326966 expires

    Listed method-of-use patent (U-1816) expiration.

    in 4 yr 3 mo

  14. Patent 9561197 expires

    Listed method-of-use patent (U-1383) expiration.

    in 4 yr 3 mo

  15. Patent 9962359 expires

    Listed method-of-use patent (U-1816) expiration.

    in 4 yr 3 mo

  16. Patent 9999608 expires

    Listed method-of-use patent (U-1816) expiration.

    in 4 yr 3 mo

  17. Patent 8404215 expires

    Listed method-of-use patent (U-1383) expiration.

    in 5 yr 8 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033TodayPatent 10045958: 2030-09-22Patent 10045958Patent 10045959: 2030-09-22Patent 10045959Patent 10183002: 2030-09-22Patent 10183002Patent 10183003: 2030-09-22Patent 10183003Patent 10183004: 2030-09-22Patent 10183004Patent 10183005: 2030-09-22Patent 10183005Patent 10183006: 2030-09-22Patent 10183006Patent 10668040: 2030-09-22Patent 10668040Patent 8642012: 2030-09-22Patent 8642012Patent 9254278: 2030-09-22Patent 9254278Patent 9326966: 2030-09-22Patent 9326966Patent 9561197: 2030-09-22Patent 9561197Patent 9962359: 2030-09-22Patent 9962359Patent 9999608: 2030-09-22Patent 9999608Patent 8404215: 2032-03-09Patent 8404215
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

GLYCEROL PHENYLBUTYRATE

Strength

1.1GM/ML

Dosage form

LIQUID

Route

ORAL

TE code

AA

Application

NDA 203284

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
10045958in 4 yr 3 mo
U-1816
10045959in 4 yr 3 mo
U-1816
10183002in 4 yr 3 mo
U-1816
10183003in 4 yr 3 mo
U-1816
10183004in 4 yr 3 mo
U-1816
10183005in 4 yr 3 mo
U-1816
10183006in 4 yr 3 mo
U-1816
10668040in 4 yr 3 mo
U-1816
8642012in 4 yr 3 mo
U-1383
9254278in 4 yr 3 mo
U-1816
9326966in 4 yr 3 mo
U-1816
9561197in 4 yr 3 mo
U-1383
9962359in 4 yr 3 mo
U-1816
9999608in 4 yr 3 mo
U-1816
8404215in 5 yr 8 mo
U-1383Delisted

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 Glycerol Phenylbutyrate 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.

Ravicti: 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 203284 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