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Orange Book drug · Brand (NDA)

Rexulti

Brexpiprazole

RLDNDA 205422 6 strengths Otsuka
Approved
Jul 10, 2015
Strengths
6
Listed patents
12

What does the FDA Orange Book show for Rexulti?

Rexulti contains Brexpiprazole and is the new drug FDA Orange Book record for NDA 205422. The application has 6 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 205422

New drug application identity from the Orange Book snapshot.

Application holder
Otsuka Pharmaceutical Co Ltd

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

Product presentations
6

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
12

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
5

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
0010.25MGTABLETORALPrescriptionAB
RLD
0020.5MGTABLETORALPrescriptionAB
RLD
0031MGTABLETORALPrescriptionAB
RLD
0042MGTABLETORALPrescriptionAB
RLDRS
0053MGTABLETORALPrescriptionAB
RLD
0064MGTABLETORALPrescriptionAB
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

Otsuka Pharmaceutical Co Ltd

The Orange Book identifies this organization as the applicant responsible for NDA 205422.

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

6 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.

Patent & exclusivity record

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

The latest future date recorded across those files is Apr 12, 2033. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

12 other ANDAs and 0 other NDAs 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 205422 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-205422

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

6 approved presentations · NDA 205422
TE ABRLD
Strength
0.25MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    11 yr 2 mo ago

  2. Patent 7888362 expires

    Listed drug substance patent expiration.

    4 mo ago

  3. Patent 8349840 expires

    Listed drug product patent expiration.

    4 mo ago

  4. Patent 8618109 expires

    Listed method-of-use patent (U-543) expiration.

    4 mo ago

  5. Patent 8618109 expires

    Listed method-of-use patent (U-3281) expiration.

    4 mo ago

  6. Patent 9839637 expires

    Listed drug product patent expiration.

    4 mo ago

  7. Patent 9839637 expires

    Listed drug product patent expiration.

    4 mo ago

  8. Patent 9839637 expires

    Listed drug product patent expiration.

    4 mo ago

  9. Exclusivity ends · I-913

    New indication exclusivity (3 years)

    3 mo ago

  10. Today

  11. Patent 7888362*PED expires

    Listed listed patent expiration.

    in 3 mo

  12. Patent 8349840*PED expires

    Listed listed patent expiration.

    in 3 mo

  13. Patent 8618109*PED expires

    Listed listed patent expiration.

    in 3 mo

  14. Patent 9839637*PED expires

    Listed listed patent expiration.

    in 3 mo

  15. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 4 mo

  16. Exclusivity ends · M-14

    New use / labeling-change exclusivity (3 years)

    in 10 mo

  17. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 1 yr 4 mo

  18. Exclusivity ends · M-315

    New use / labeling-change exclusivity (3 years)

    in 1 yr 10 mo

  19. Patent RE48059 expires

    Listed drug substance patent expiration.

    in 2 yr 5 mo

  20. Patent RE48059*PED expires

    Listed listed patent expiration.

    in 2 yr 11 mo

  21. Patent 10307419 expires

    Listed drug product patent expiration.

    in 6 yr 4 mo

  22. Patent 10307419*PED expires

    Listed listed patent expiration.

    in 6 yr 10 mo

Patent & exclusivity timeline

Protection horizon
202620272028202920302031203220332034TodayPatent 7888362: 2026-04-12Patent 7888362Patent 8349840: 2026-04-12Patent 8349840Patent 8618109: 2026-04-12Patent 8618109Patent 8618109: 2026-04-12Patent 8618109Patent 9839637: 2026-04-12Patent 9839637Patent 9839637: 2026-04-12Patent 9839637Patent 9839637: 2026-04-12Patent 9839637Exclusivity I-913: 2026-05-10Exclusivity I-913Patent 7888362*PED: 2026-10-12Patent 7888362*PEDPatent 8349840*PED: 2026-10-12Patent 8349840*PEDPatent 8618109*PED: 2026-10-12Patent 8618109*PEDPatent 9839637*PED: 2026-10-12Patent 9839637*PEDExclusivity PED: 2026-11-10Exclusivity PEDExclusivity M-14: 2027-05-08Exclusivity M-14Exclusivity PED: 2027-11-08Exclusivity PEDExclusivity M-315: 2028-05-09Exclusivity M-315Patent RE48059: 2028-12-23Patent RE48059Patent RE48059*PED: 2029-06-23Patent RE48059*PEDPatent 10307419: 2032-10-12Patent 10307419Patent 10307419*PED: 2033-04-12Patent 10307419*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

BREXPIPRAZOLE

Strength

0.25MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 205422

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • I-913New indication exclusivity (3 years)

    3 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    in 4 mo

  • M-14New use / labeling-change exclusivity (3 years)

    in 10 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 1 yr 4 mo

  • M-315New use / labeling-change exclusivity (3 years)

    in 1 yr 10 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
78883624 mo ago
SubstanceDelisted
83498404 mo ago
ProductU-1529
86181094 mo ago
U-543
86181094 mo ago
U-3281
98396374 mo ago
ProductU-1529
98396374 mo ago
ProductU-3281
98396374 mo ago
ProductU-543
7888362*PEDin 3 mo
8349840*PEDin 3 mo
8618109*PEDin 3 mo
9839637*PEDin 3 mo
RE48059in 2 yr 5 mo
Substance
RE48059*PEDin 2 yr 11 mo
10307419in 6 yr 4 mo
Product
10307419*PEDin 6 yr 10 mo

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 Brexpiprazole 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.

Rexulti: 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 205422 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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