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Rexulti

Brexpiprazole · Kit

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
Rexulti
Generic name
Brexpiprazole
Dosage form
Kit
Route
—
Marketing category
NDA · NDA
Labeler
Otsuka America Pharmaceutical, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
4

Regulatory status

Source: Drugs@FDANDC Directory
Application number
205422
Application type
NDA · New Drug Application
Approval date
July 10, 2015
Sponsor
OTSUKA
Products on application
6
Submissions recorded
13
Products approved under application 205422.
Product Trade name Form Strength Ingredient Status TE Flags
205422-001 REXULTI TABLET BREXPIPRAZOLE Prescription AB RLD
205422-002 REXULTI TABLET BREXPIPRAZOLE Prescription AB RLD
205422-003 REXULTI TABLET BREXPIPRAZOLE Prescription AB RLD
205422-004 REXULTI TABLET BREXPIPRAZOLE Prescription AB RLD RS
205422-005 REXULTI TABLET BREXPIPRAZOLE Prescription AB RLD
205422-006 REXULTI TABLET BREXPIPRAZOLE Prescription AB RLD

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9839637 April 12, 2026 001 No U-1529 January 9, 2018
8618109 April 12, 2026 001 No U-543 July 17, 2015
8349840 April 12, 2026 001 No U-1529 July 17, 2015
9839637 April 12, 2026 001 No U-3281 January 9, 2018
8618109 April 12, 2026 001 No U-3281 July 17, 2015
9839637 April 12, 2026 001 No U-543 January 9, 2018
8618109 April 12, 2026 002 No U-543 July 17, 2015
9839637 April 12, 2026 002 No U-543 January 9, 2018
8349840 April 12, 2026 002 No U-1529 July 17, 2015
9839637 April 12, 2026 002 No U-1529 January 9, 2018
9839637 April 12, 2026 002 No U-3281 January 9, 2018
8618109 April 12, 2026 002 No U-3281 July 17, 2015
9839637 April 12, 2026 003 No U-1529 January 9, 2018
9839637 April 12, 2026 003 No U-543 January 9, 2018
8349840 April 12, 2026 003 No U-1529 July 23, 2015
8618109 April 12, 2026 003 No U-543 July 23, 2015
9839637 April 12, 2026 003 No U-3281 January 9, 2018
8618109 April 12, 2026 003 No U-3281 July 23, 2015
8618109 April 12, 2026 004 No U-543 July 23, 2015
9839637 April 12, 2026 004 No U-1529 January 9, 2018
9839637 April 12, 2026 004 No U-543 January 9, 2018
9839637 April 12, 2026 004 No U-3281 January 9, 2018
8618109 April 12, 2026 004 No U-3281 July 23, 2015
8349840 April 12, 2026 004 No U-1529 July 23, 2015
9839637 April 12, 2026 005 No U-543 January 9, 2018
8349840 April 12, 2026 005 No U-1529 July 23, 2015
8618109 April 12, 2026 005 No U-543 July 23, 2015
9839637 April 12, 2026 005 No U-1529 January 9, 2018
9839637 April 12, 2026 005 No U-3281 January 9, 2018
8618109 April 12, 2026 005 No U-3281 July 23, 2015
8349840 April 12, 2026 006 No U-1529 July 23, 2015
9839637 April 12, 2026 006 No U-543 January 9, 2018
8618109 April 12, 2026 006 No U-543 July 23, 2015
9839637 April 12, 2026 006 No U-1529 January 9, 2018
9839637 April 12, 2026 006 No U-3281 January 9, 2018
8618109 April 12, 2026 006 No U-3281 July 23, 2015
9839637*PED October 12, 2026 001 No —
8618109*PED October 12, 2026 001 No —
8349840*PED October 12, 2026 001 No —
9839637*PED October 12, 2026 002 No —
8618109*PED October 12, 2026 002 No —
8349840*PED October 12, 2026 002 No —
9839637*PED October 12, 2026 003 No —
8618109*PED October 12, 2026 003 No —
8349840*PED October 12, 2026 003 No —
9839637*PED October 12, 2026 004 No —
8618109*PED October 12, 2026 004 No —
8349840*PED October 12, 2026 004 No —
9839637*PED October 12, 2026 005 No —
8618109*PED October 12, 2026 005 No —
8349840*PED October 12, 2026 005 No —
9839637*PED October 12, 2026 006 No —
8618109*PED October 12, 2026 006 No —
8349840*PED October 12, 2026 006 No —
RE48059 December 23, 2028 001 Yes July 20, 2020
RE48059 December 23, 2028 002 Yes July 20, 2020
RE48059 December 23, 2028 003 Yes July 20, 2020
RE48059 December 23, 2028 004 Yes July 20, 2020
RE48059 December 23, 2028 005 Yes July 20, 2020
RE48059 December 23, 2028 006 Yes July 20, 2020
RE48059*PED June 23, 2029 001 No —
RE48059*PED June 23, 2029 002 No —
RE48059*PED June 23, 2029 003 No —
RE48059*PED June 23, 2029 004 No —
RE48059*PED June 23, 2029 005 No —
RE48059*PED June 23, 2029 006 No —
10307419 October 12, 2032 001 No June 14, 2019
10307419 October 12, 2032 002 No June 14, 2019
10307419 October 12, 2032 003 No June 14, 2019
10307419 October 12, 2032 004 No June 14, 2019
10307419 October 12, 2032 005 No June 14, 2019
10307419*PED April 12, 2033 001 No —
10307419*PED April 12, 2033 002 No —
10307419*PED April 12, 2033 003 No —
10307419*PED April 12, 2033 004 No —
10307419*PED April 12, 2033 005 No —
Regulatory exclusivity periods.
Code Expires Product
I-913 May 10, 2026 001
I-913 May 10, 2026 002
I-913 May 10, 2026 003
I-913 May 10, 2026 004
I-913 May 10, 2026 005
I-913 May 10, 2026 006
PED November 10, 2026 001
PED November 10, 2026 002
PED November 10, 2026 003
PED November 10, 2026 004
PED November 10, 2026 005
PED November 10, 2026 006
M-14 May 8, 2027 001
M-14 May 8, 2027 002
M-14 May 8, 2027 003
M-14 May 8, 2027 004
M-14 May 8, 2027 005
M-14 May 8, 2027 006
PED November 8, 2027 001
PED November 8, 2027 002
PED November 8, 2027 003
PED November 8, 2027 004
PED November 8, 2027 005
PED November 8, 2027 006
M-315 May 9, 2028 001
M-315 May 9, 2028 002
M-315 May 9, 2028 003
M-315 May 9, 2028 004
M-315 May 9, 2028 005
M-315 May 9, 2028 006

Approval history

Source: Drugs@FDA
Most recent submissions on application 205422.
Type No. Action Status Date Review
Supplement 17 Labeling Approved April 30, 2026 Standard
Supplement 14 Efficacy Approved May 9, 2025 Standard
Supplement 13 Labeling Approved December 11, 2024 Standard
Supplement 11 Efficacy Approved May 7, 2024 Priority
Supplement 9 Efficacy Approved May 10, 2023 Priority
Supplement 8 Labeling Approved October 6, 2022 Standard
Supplement 7 Efficacy Approved December 27, 2021 Priority
Supplement 5 Labeling Approved June 17, 2020 Standard
Supplement 3 Labeling Approved February 9, 2018 Standard
Supplement 2 Labeling Approved February 23, 2017 901 Required
Supplement 1 Efficacy Approved September 23, 2016 Standard
Original application 2 Efficacy Approved July 10, 2015 Standard
Original application 1 Type 1 - New Molecular Entity Approved July 10, 2015 Standard

Review documents

  • 0 · Supplement · May 5, 2026
  • 0 · Supplement · May 5, 2026
  • 0 · Supplement · May 4, 2026
  • 0 · Supplement · May 15, 2025
  • 0 · Supplement · May 9, 2025
  • 0 · Supplement · December 13, 2024
  • 0 · Supplement · December 13, 2024
  • 0 · Supplement · May 8, 2024
  • 0 · Supplement · May 8, 2024
  • 0 · Supplement · May 8, 2024
  • 0 · Supplement · September 25, 2023
  • 0 · Supplement · May 11, 2023
  • 0 · Supplement · May 11, 2023
  • 0 · Supplement · October 11, 2022
  • 0 · Supplement · October 7, 2022
  • 0 · Supplement · December 29, 2021
  • 0 · Supplement · December 28, 2021
  • 0 · Supplement · June 19, 2020
  • 0 · Supplement · June 19, 2020
  • 0 · Original application · June 17, 2019
  • 0 · Supplement · February 14, 2018
  • 0 · Supplement · February 12, 2018
  • 0 · Supplement · March 2, 2017
  • 0 · Supplement · February 24, 2017
  • 0 · Supplement · September 29, 2016
  • 0 · Supplement · September 26, 2016
  • 0 · Original application · August 19, 2015
  • 0 · Original application · July 13, 2015
  • 0 · Original application · July 13, 2015

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
59148-042-07 59148-042 Otsuka America Pharmaceutical, Inc. 1 KIT in 1 CARTON (59148-042-07) * 4 TABLET in 1 BLISTER PACK * 3 TABLET in 1 BLISTER PACK July 10, 2015
59148-044-14 59148-044 Otsuka America Pharmaceutical, Inc. 1 KIT in 1 CARTON (59148-044-14) * 7 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK July 10, 2015
59148-042 59148-042 Otsuka America Pharmaceutical, Inc. — July 10, 2015
59148-044 59148-044 Otsuka America Pharmaceutical, Inc. — July 10, 2015

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 9 sections on this page.