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Orange Book drug · Brand (NDA)

Procysbi

Cysteamine Bitartrate

RLDNDA 203389 2 strengths Horizon
Approved
Apr 30, 2013
Strengths
2
Listed patents
24
Applications
2

What does the FDA Orange Book show for Procysbi?

Procysbi contains Cysteamine Bitartrate and appears in 2 FDA Orange Book applications. NDA 203389 is the lead filing, with 2 presentations 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 203389

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

Lead application holder
Horizon Therapeutics USA Inc

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

Product presentations
2

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
24

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 25MG BASECAPSULE, DELAYED RELEASEORALPrescriptionNone posted
RLD
002EQ 75MG BASECAPSULE, DELAYED RELEASEORALPrescriptionNone 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

Horizon Therapeutics USA Inc

The Orange Book identifies this organization as the applicant responsible for NDA 203389.

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

2 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

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

The latest future date recorded across those files is Feb 16, 2037. 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 1 other NDA 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 203389 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Capsule, Delayed Release · Oral

Cysteamine Bitartrate

1 application
Product rows
2
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-203389

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

2 approved presentations · NDA 203389
RLD
Strength
EQ 25MG BASE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    13 yr 5 mo ago

  2. Today

  3. Patent 9192590 expires

    Listed method-of-use patent (U-1399) expiration.

    in 6 mo

  4. Patent 9198882 expires

    Listed method-of-use patent (U-1399) expiration.

    in 6 mo

  5. Patent 9925156 expires

    Listed drug substance patent expiration.

    in 6 mo

  6. Patent 9925157 expires

    Listed drug substance patent expiration.

    in 6 mo

  7. Patent 9925158 expires

    Listed drug substance patent expiration.

    in 6 mo

  8. Patent 9192590*PED expires

    Listed listed patent expiration.

    in 1 yr

  9. Patent 9198882*PED expires

    Listed listed patent expiration.

    in 1 yr

  10. Patent 9925156*PED expires

    Listed listed patent expiration.

    in 1 yr

  11. Patent 9925157*PED expires

    Listed listed patent expiration.

    in 1 yr

  12. Patent 9925158*PED expires

    Listed listed patent expiration.

    in 1 yr

  13. Patent 8026284 expires

    Listed method-of-use patent (U-1399) expiration.

    in 1 yr 2 mo

  14. Patent 8026284*PED expires

    Listed listed patent expiration.

    in 1 yr 8 mo

  15. Patent 9173851 expires

    Listed drug product patent expiration.

    in 8 yr

  16. Patent 9233077 expires

    Listed drug product patent expiration.

    in 8 yr

  17. Patent 9173851*PED expires

    Listed listed patent expiration.

    in 8 yr 6 mo

  18. Patent 9233077*PED expires

    Listed listed patent expiration.

    in 8 yr 6 mo

  19. Patent 10143665 expires

    Listed method-of-use patent (U-1399) expiration.

    in 10 yr 2 mo

  20. Patent 10328037 expires

    Listed method-of-use patent (U-1399) expiration.

    in 10 yr 2 mo

  21. Patent 10548859 expires

    Listed method-of-use patent (U-1399) expiration.

    in 10 yr 2 mo

  22. Patent 10905662 expires

    Listed method-of-use patent (U-1399) expiration.

    in 10 yr 2 mo

  23. Patent 10143665*PED expires

    Listed listed patent expiration.

    in 10 yr 9 mo

  24. Patent 10328037*PED expires

    Listed listed patent expiration.

    in 10 yr 9 mo

  25. Patent 10548859*PED expires

    Listed listed patent expiration.

    in 10 yr 9 mo

  26. Patent 10905662*PED expires

    Listed listed patent expiration.

    in 10 yr 9 mo

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038TodayPatent 9192590: 2027-01-26Patent 9192590Patent 9198882: 2027-01-26Patent 9198882Patent 9925156: 2027-01-26Patent 9925156Patent 9925157: 2027-01-26Patent 9925157Patent 9925158: 2027-01-26Patent 9925158Patent 9192590*PED: 2027-07-26Patent 9192590*PEDPatent 9198882*PED: 2027-07-26Patent 9198882*PEDPatent 9925156*PED: 2027-07-26Patent 9925156*PEDPatent 9925157*PED: 2027-07-26Patent 9925157*PEDPatent 9925158*PED: 2027-07-26Patent 9925158*PEDPatent 8026284: 2027-09-22Patent 8026284Patent 8026284*PED: 2028-03-22Patent 8026284*PEDPatent 9173851: 2034-06-17Patent 9173851Patent 9233077: 2034-06-17Patent 9233077Patent 9173851*PED: 2034-12-17Patent 9173851*PEDPatent 9233077*PED: 2034-12-17Patent 9233077*PEDPatent 10143665: 2036-08-16Patent 10143665Patent 10328037: 2036-08-16Patent 10328037Patent 10548859: 2036-08-16Patent 10548859Patent 10905662: 2036-08-16Patent 10905662Patent 10143665*PED: 2037-02-16Patent 10143665*PEDPatent 10328037*PED: 2037-02-16Patent 10328037*PEDPatent 10548859*PED: 2037-02-16Patent 10548859*PEDPatent 10905662*PED: 2037-02-16Patent 10905662*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

CYSTEAMINE BITARTRATE

Strength

EQ 25MG BASE

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 203389

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9192590in 6 mo
U-1399
9198882in 6 mo
U-1399
9925156in 6 mo
SubstanceProductU-1399
9925157in 6 mo
SubstanceProductU-1399
9925158in 6 mo
SubstanceProductU-1399
9192590*PEDin 1 yr
9198882*PEDin 1 yr
9925156*PEDin 1 yr
9925157*PEDin 1 yr
9925158*PEDin 1 yr
8026284in 1 yr 2 mo
U-1399
8026284*PEDin 1 yr 8 mo
9173851in 8 yr
Product
9233077in 8 yr
Product
9173851*PEDin 8 yr 6 mo
9233077*PEDin 8 yr 6 mo
10143665in 10 yr 2 mo
U-1399
10328037in 10 yr 2 mo
U-1399
10548859in 10 yr 2 mo
U-1399
10905662in 10 yr 2 mo
U-1399
10143665*PEDin 10 yr 9 mo
10328037*PEDin 10 yr 9 mo
10548859*PEDin 10 yr 9 mo
10905662*PEDin 10 yr 9 mo

Other FDA applications for Procysbi

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 Procysbi, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 213491HorizonFeb 14, 20202—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.

View full Cysteamine Bitartrate 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.

Procysbi: 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 203389 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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