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Orange Book drug · Brand (NDA)

Gavreto

Pralsetinib

RLDNDA 213721 Rigel Pharms
Approved
Sep 04, 2020
Strengths
1
Listed patents
6

What does the FDA Orange Book show for Gavreto?

Gavreto contains Pralsetinib and is the new drug FDA Orange Book record for NDA 213721. 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 213721

New drug application identity from the Orange Book snapshot.

Application holder
Rigel 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
None posted

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

Listed patents
6

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
001100MGCAPSULEORALPrescriptionNone 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

Rigel Pharmaceuticals Inc

The Orange Book identifies this organization as the applicant responsible for NDA 213721.

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

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

The latest future date recorded across those files is Jul 07, 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 213721 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 · Oral

Pralsetinib

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-213721

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 213721
RLDRS
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    6 yr ago

  2. Today

  3. Exclusivity ends · ODE-318

    Orphan-drug exclusivity (7 years)

    in 1 yr 2 mo

  4. Exclusivity ends · ODE-340

    Orphan-drug exclusivity (7 years)

    in 1 yr 4 mo

  5. Exclusivity ends · ODE-341

    Orphan-drug exclusivity (7 years)

    in 1 yr 4 mo

  6. Patent 10030005 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  7. Patent 10030005 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  8. Patent 11273160 expires

    Listed method-of-use patent (U-2952) expiration.

    in 12 yr 10 mo

  9. Patent 11872192 expires

    Listed method-of-use patent (U-2952) expiration.

    in 12 yr 10 mo

  10. Patent 11963958 expires

    Listed method-of-use patent (U-2828) expiration.

    in 12 yr 10 mo

  11. Patent 12539303 expires

    Listed method-of-use patent (U-2828) expiration.

    in 12 yr 10 mo

  12. Patent 12448366 expires

    Listed drug substance patent expiration.

    in 16 yr 2 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayExclusivity ODE-318: 2027-09-04Exclusivity ODE-318Exclusivity ODE-340: 2027-12-01Exclusivity ODE-340Exclusivity ODE-341: 2027-12-01Exclusivity ODE-341Patent 10030005: 2036-11-01Patent 10030005Patent 10030005: 2036-11-01Patent 10030005Patent 11273160: 2039-04-03Patent 11273160Patent 11872192: 2039-04-03Patent 11872192Patent 11963958: 2039-04-03Patent 11963958Patent 12539303: 2039-04-03Patent 12539303Patent 12448366: 2042-07-07Patent 12448366
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

PRALSETINIB

Strength

100MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 213721

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • ODE-318Orphan-drug exclusivity (7 years)

    in 1 yr 2 mo

  • ODE-340Orphan-drug exclusivity (7 years)

    in 1 yr 4 mo

  • ODE-341Orphan-drug exclusivity (7 years)

    in 1 yr 4 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10030005in 10 yr 5 mo
SubstanceProductU-2952
10030005in 10 yr 5 mo
SubstanceProductU-3002
11273160in 12 yr 10 mo
U-2952
11872192in 12 yr 10 mo
U-2952
11963958in 12 yr 10 mo
U-2828
12539303in 12 yr 10 mo
U-2828
12448366in 16 yr 2 mo
Substance

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 Pralsetinib 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.

Gavreto: 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 213721 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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