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Orange Book drug · Brand (NDA)

Sephience

Sepiapterin

RLDNDA 219666 2 strengths Ptc Therap
Approved
Jul 28, 2025
Strengths
2
Listed patents
4

What does the FDA Orange Book show for Sephience?

Sephience contains Sepiapterin and is the new drug FDA Orange Book record for NDA 219666. The application has 2 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 219666

New drug application identity from the Orange Book snapshot.

Application holder
Ptc Therapeutics 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
4

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
001250MG/PACKETPOWDERORALPrescriptionNone posted
RLD
0021GM/PACKETPOWDERORALPrescriptionNone 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

Ptc Therapeutics Inc

The Orange Book identifies this organization as the applicant responsible for NDA 219666.

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

4 listed patent expirations and 2 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Mar 06, 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 219666 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Powder · Oral

Sepiapterin

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-219666

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 219666
RLD
Strength
250MG/PACKET
Dosage form
POWDER
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    1 yr ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    in 4 yr 1 mo

  4. Exclusivity ends · ODE-542

    Orphan-drug exclusivity (7 years)

    in 6 yr 1 mo

  5. Patent 11072614 expires

    Listed drug substance patent expiration.

    in 11 yr 11 mo

  6. Patent 11752154 expires

    Listed drug product patent expiration.

    in 12 yr 3 mo

  7. Patent 12213982 expires

    Listed method-of-use patent (U-4251) expiration.

    in 12 yr 3 mo

  8. Patent 12257252 expires

    Listed method-of-use patent (U-4250) expiration.

    in 15 yr 10 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayExclusivity NCE: 2030-07-28Exclusivity NCEExclusivity ODE-542: 2032-07-28Exclusivity ODE-542Patent 11072614: 2038-04-16Patent 11072614Patent 11752154: 2038-09-04Patent 11752154Patent 12213982: 2038-09-04Patent 12213982Patent 12257252: 2042-03-06Patent 12257252
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

SEPIAPTERIN

Strength

250MG/PACKET

Dosage form

POWDER

Route

ORAL

TE code

Not listed

Application

NDA 219666

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

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

    in 4 yr 1 mo

  • ODE-542Orphan-drug exclusivity (7 years)

    in 6 yr 1 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11072614in 11 yr 11 mo
SubstanceU-4251
11752154in 12 yr 3 mo
ProductU-4251
12213982in 12 yr 3 mo
U-4251
12257252in 15 yr 10 mo
U-4250

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 Sepiapterin 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.

Sephience: 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 219666 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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