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Orange Book drug · Brand (NDA)

Ingrezza

Valbenazine Tosylate

RLDNDA 209241 3 strengths Neurocrine
Approved
Apr 11, 2017
Strengths
3
Listed patents
22

What does the FDA Orange Book show for Ingrezza?

Ingrezza contains Valbenazine Tosylate and is the new drug FDA Orange Book record for NDA 209241. The application has 3 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 209241

New drug application identity from the Orange Book snapshot.

Application holder
Neurocrine Biosciences Inc

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

Product presentations
3

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
AB

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

Listed patents
22

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
001EQ 40MG BASECAPSULEORALPrescriptionAB
RLD
002EQ 80MG BASECAPSULEORALPrescriptionAB
RLDRS
003EQ 60MG BASECAPSULEORALPrescriptionNone posted
RLD

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

Neurocrine Biosciences Inc

The Orange Book identifies this organization as the applicant responsible for NDA 209241.

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

3 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

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group. 1 presentation in the application has no posted TE code.

Patent & exclusivity record

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

The latest future date recorded across those files is Aug 10, 2040. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

2 other ANDAs and 1 other NDA found

1 of the related ANDA application is 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 209241 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-209241

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

3 approved presentations · NDA 209241
TE ABRLD
Strength
EQ 40MG BASE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    9 yr 5 mo ago

  2. Today

  3. Exclusivity ends · I-925

    New indication exclusivity (3 years)

    in 23 d

  4. Patent 8357697 expires

    Listed method-of-use patent (U-3055) expiration.

    in 1 yr 4 mo

  5. Patent 8357697 expires

    Listed method-of-use patent (U-1995) expiration.

    in 1 yr 4 mo

  6. Exclusivity ends · ODE-440

    Orphan-drug exclusivity (7 years)

    in 4 yr 1 mo

  7. Patent 8039627 expires

    Listed drug substance patent expiration.

    in 4 yr 9 mo

  8. Patent 10065952 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  9. Patent 10065952 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  10. Patent 10844058 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  11. Patent 10844058 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  12. Patent 10851103 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  13. Patent 10851103 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  14. Patent 10851104 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  15. Patent 10851104 expires

    Listed drug substance patent expiration.

    in 10 yr 5 mo

  16. Patent 10906902 expires

    Listed drug substance patent expiration.

    in 10 yr 7 mo

  17. Patent 10906903 expires

    Listed drug substance patent expiration.

    in 10 yr 7 mo

  18. Patent 10919892 expires

    Listed drug substance patent expiration.

    in 10 yr 7 mo

  19. Patent 10857137 expires

    Listed method-of-use patent (U-1995) expiration.

    in 11 yr 4 mo

  20. Patent 10857148 expires

    Listed method-of-use patent (U-1995) expiration.

    in 11 yr 4 mo

  21. Patent 10874648 expires

    Listed method-of-use patent (U-1995) expiration.

    in 11 yr 4 mo

  22. Patent 10874648 expires

    Listed method-of-use patent (U-3046) expiration.

    in 11 yr 4 mo

  23. Patent 10874648 expires

    Listed method-of-use patent (U-3055) expiration.

    in 11 yr 4 mo

  24. Patent 10912771 expires

    Listed method-of-use patent (U-3055) expiration.

    in 11 yr 4 mo

  25. Patent 10912771 expires

    Listed method-of-use patent (U-1995) expiration.

    in 11 yr 4 mo

  26. Patent 10912771 expires

    Listed method-of-use patent (U-3076) expiration.

    in 11 yr 4 mo

  27. Patent 10952997 expires

    Listed method-of-use patent (U-1995) expiration.

    in 11 yr 4 mo

  28. Patent 10993941 expires

    Listed method-of-use patent (U-1995) expiration.

    in 11 yr 4 mo

  29. Patent 11040029 expires

    Listed method-of-use patent (U-1995) expiration.

    in 11 yr 4 mo

  30. Patent 11439629 expires

    Listed method-of-use patent (U-3055) expiration.

    in 11 yr 4 mo

  31. Patent 11026939 expires

    Listed drug product patent expiration.

    in 12 yr 4 mo

  32. Patent 11026939 expires

    Listed drug product patent expiration.

    in 12 yr 4 mo

  33. Patent 11311532 expires

    Listed drug product patent expiration.

    in 12 yr 4 mo

  34. Patent 11311532 expires

    Listed drug product patent expiration.

    in 12 yr 4 mo

  35. Patent 11654142 expires

    Listed method-of-use patent (U-3055) expiration.

    in 12 yr 6 mo

  36. Patent 11026931 expires

    Listed method-of-use patent (U-1995) expiration.

    in 13 yr 3 mo

  37. Patent 10940141 expires

    Listed method-of-use patent (U-1995) expiration.

    in 14 yr 3 mo

Patent & exclusivity timeline

Protection horizon
20262028203020322034203620382040TodayExclusivity I-925: 2026-08-18Exclusivity I-925Patent 8357697: 2027-11-08Patent 8357697Patent 8357697: 2027-11-08Patent 8357697Exclusivity ODE-440: 2030-08-18Exclusivity ODE-440Patent 8039627: 2031-04-11Patent 8039627Patent 10065952: 2036-10-28Patent 10065952Patent 10065952: 2036-10-28Patent 10065952Patent 10844058: 2036-10-28Patent 10844058Patent 10844058: 2036-10-28Patent 10844058Patent 10851103: 2036-10-28Patent 10851103Patent 10851103: 2036-10-28Patent 10851103Patent 10851104: 2036-10-28Patent 10851104Patent 10851104: 2036-10-28Patent 10851104Patent 10906902: 2036-12-22Patent 10906902Patent 10906903: 2036-12-22Patent 10906903Patent 10919892: 2036-12-22Patent 10919892Patent 10857137: 2037-10-10Patent 10857137Patent 10857148: 2037-10-10Patent 10857148Patent 10874648: 2037-10-10Patent 10874648Patent 10874648: 2037-10-10Patent 10874648Patent 10874648: 2037-10-10Patent 10874648Patent 10912771: 2037-10-10Patent 10912771Patent 10912771: 2037-10-10Patent 10912771Patent 10912771: 2037-10-10Patent 10912771Patent 10952997: 2037-10-10Patent 10952997Patent 10993941: 2037-10-10Patent 10993941Patent 11040029: 2037-10-10Patent 11040029Patent 11439629: 2037-10-10Patent 11439629Patent 11026939: 2038-09-18Patent 11026939Patent 11026939: 2038-09-18Patent 11026939Patent 11311532: 2038-09-18Patent 11311532Patent 11311532: 2038-09-18Patent 11311532Patent 11654142: 2038-11-14Patent 11654142Patent 11026931: 2039-08-14Patent 11026931Patent 10940141: 2040-08-10Patent 10940141
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

VALBENAZINE TOSYLATE

Strength

EQ 40MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

NDA 209241

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • I-925New indication exclusivity (3 years)

    in 23 d

  • ODE-440Orphan-drug exclusivity (7 years)

    in 4 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
8357697in 1 yr 4 mo
U-3055
8357697in 1 yr 4 mo
U-1995
8039627in 4 yr 9 mo
SubstanceProduct
10065952in 10 yr 5 mo
SubstanceProductU-1995
10065952in 10 yr 5 mo
SubstanceProductU-3055
10844058in 10 yr 5 mo
SubstanceProductU-1995
10844058in 10 yr 5 mo
SubstanceProductU-3055
10851103in 10 yr 5 mo
SubstanceProductU-1995
10851103in 10 yr 5 mo
SubstanceProductU-3055
10851104in 10 yr 5 mo
SubstanceU-1995
10851104in 10 yr 5 mo
SubstanceU-3055
10906902in 10 yr 7 mo
SubstanceProduct
10906903in 10 yr 7 mo
SubstanceProduct
10919892in 10 yr 7 mo
SubstanceProduct
10857137in 11 yr 4 mo
U-1995
10857148in 11 yr 4 mo
U-1995
10874648in 11 yr 4 mo
U-1995
10874648in 11 yr 4 mo
U-3046
10874648in 11 yr 4 mo
U-3055
10912771in 11 yr 4 mo
U-3055
10912771in 11 yr 4 mo
U-1995
10912771in 11 yr 4 mo
U-3076
10952997in 11 yr 4 mo
U-1995
10993941in 11 yr 4 mo
U-1995
11040029in 11 yr 4 mo
U-1995
11439629in 11 yr 4 mo
U-3055
11026939in 12 yr 4 mo
ProductU-3055
11026939in 12 yr 4 mo
ProductU-1995
11311532in 12 yr 4 mo
ProductU-1995
11311532in 12 yr 4 mo
ProductU-3055
11654142in 12 yr 6 mo
U-3055
11026931in 13 yr 3 mo
U-1995
10940141in 14 yr 3 mo
U-1995

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 Valbenazine Tosylate 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.

Ingrezza: 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 209241 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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