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INGREZZA

Valbenazine · 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
INGREZZA
Generic name
Valbenazine
Dosage form
Kit
Route
Oral
Marketing category
NDA · NDA
Labeler
Neurocrine Biosciences, 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
Oral
Presentations
4

Regulatory status

Source: Drugs@FDANDC Directory
Application number
209241
Application type
NDA · New Drug Application
Approval date
April 11, 2017
Sponsor
NEUROCRINE
Products on application
3
Submissions recorded
10
Products approved under application 209241.
Product Trade name Form Strength Ingredient Status TE Flags
209241-001 INGREZZA CAPSULE VALBENAZINE TOSYLATE Prescription AB RLD
209241-002 INGREZZA CAPSULE VALBENAZINE TOSYLATE Prescription AB RLD RS
209241-003 INGREZZA CAPSULE VALBENAZINE TOSYLATE 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
8357697 November 8, 2027 001 No U-3055 April 26, 2017
8357697 November 8, 2027 001 No U-1995 April 26, 2017
8357697 November 8, 2027 002 No U-1995 October 27, 2017
8357697 November 8, 2027 002 No U-3055 October 27, 2017
8357697 November 8, 2027 003 No U-3055 May 19, 2021
8357697 November 8, 2027 003 No U-1995 May 19, 2021
8039627 April 11, 2031 001 Yes April 26, 2017
8039627 April 11, 2031 002 Yes October 27, 2017
8039627 April 11, 2031 003 Yes May 19, 2021
10844058 October 28, 2036 001 Yes U-1995 December 18, 2020
10851103 October 28, 2036 001 Yes U-1995 December 18, 2020
10851104 October 28, 2036 001 Yes U-1995 December 18, 2020
10065952 October 28, 2036 001 Yes U-1995 September 26, 2018
10851104 October 28, 2036 001 Yes U-3055 December 18, 2020
10851103 October 28, 2036 001 Yes U-3055 December 18, 2020
10844058 October 28, 2036 001 Yes U-3055 December 18, 2020
10065952 October 28, 2036 001 Yes U-3055 September 26, 2018
10065952 October 28, 2036 002 Yes U-1995 September 26, 2018
10851104 October 28, 2036 002 Yes U-1995 December 18, 2020
10851103 October 28, 2036 002 Yes U-1995 December 18, 2020
10844058 October 28, 2036 002 Yes U-1995 December 18, 2020
10851104 October 28, 2036 002 Yes U-3055 December 18, 2020
10851103 October 28, 2036 002 Yes U-3055 December 18, 2020
10844058 October 28, 2036 002 Yes U-3055 December 18, 2020
10065952 October 28, 2036 002 Yes U-3055 September 26, 2018
10851104 October 28, 2036 003 Yes U-3055 May 19, 2021
10851103 October 28, 2036 003 Yes U-3055 May 19, 2021
10844058 October 28, 2036 003 Yes U-3055 May 19, 2021
10065952 October 28, 2036 003 Yes U-3055 May 19, 2021
10851104 October 28, 2036 003 Yes U-1995 May 19, 2021
10844058 October 28, 2036 003 Yes U-1995 May 19, 2021
10851103 October 28, 2036 003 Yes U-1995 May 19, 2021
10065952 October 28, 2036 003 Yes U-1995 May 19, 2021
10906902 December 22, 2036 001 Yes March 3, 2021
10919892 December 22, 2036 001 Yes March 3, 2021
10906903 December 22, 2036 001 Yes March 3, 2021
10919892 December 22, 2036 002 Yes March 3, 2021
10906903 December 22, 2036 002 Yes March 3, 2021
10906902 December 22, 2036 002 Yes March 3, 2021
10906902 December 22, 2036 003 Yes May 19, 2021
10906903 December 22, 2036 003 Yes May 19, 2021
10919892 December 22, 2036 003 Yes May 19, 2021
10874648 October 10, 2037 001 No U-1995 January 25, 2021
10874648 October 10, 2037 001 No U-3046 January 25, 2021
10857137 October 10, 2037 001 No U-1995 December 18, 2020
10857148 October 10, 2037 001 No U-1995 December 18, 2020
10952997 October 10, 2037 001 No U-1995 April 6, 2021
11439629 October 10, 2037 001 No U-3055 September 14, 2023
10912771 October 10, 2037 001 No U-3055 March 3, 2021
10874648 October 10, 2037 001 No U-3055 January 25, 2021
10993941 October 10, 2037 001 No U-1995 May 19, 2021
11040029 October 10, 2037 001 No U-1995 June 30, 2021
10912771 October 10, 2037 001 No U-1995 March 3, 2021
10912771 October 10, 2037 001 No U-3076 March 3, 2021
10874648 October 10, 2037 002 No U-1995 January 25, 2021
10874648 October 10, 2037 002 No U-3046 January 25, 2021
10857148 October 10, 2037 002 No U-1995 December 18, 2020
10857137 October 10, 2037 002 No U-1995 December 18, 2020
10952997 October 10, 2037 002 No U-1995 April 6, 2021
11439629 October 10, 2037 002 No U-3055 September 14, 2023
10912771 October 10, 2037 002 No U-3055 March 3, 2021
10874648 October 10, 2037 002 No U-3055 January 25, 2021
10993941 October 10, 2037 002 No U-1995 May 19, 2021
11040029 October 10, 2037 002 No U-1995 June 30, 2021
10912771 October 10, 2037 002 No U-1995 March 3, 2021
10912771 October 10, 2037 002 No U-3076 March 3, 2021
11439629 October 10, 2037 003 No U-3055 September 14, 2023
10912771 October 10, 2037 003 No U-3055 May 19, 2021
10874648 October 10, 2037 003 No U-3055 May 19, 2021
10857137 October 10, 2037 003 No U-1995 May 19, 2021
10857148 October 10, 2037 003 No U-1995 May 19, 2021
10874648 October 10, 2037 003 No U-1995 May 19, 2021
10874648 October 10, 2037 003 No U-3046 May 19, 2021
10912771 October 10, 2037 003 No U-3076 May 19, 2021
10912771 October 10, 2037 003 No U-1995 May 19, 2021
10993941 October 10, 2037 003 No U-1995 May 19, 2021
10952997 October 10, 2037 003 No U-1995 May 19, 2021
11040029 October 10, 2037 003 No U-1995 June 30, 2021
11311532 September 18, 2038 001 No U-1995 May 17, 2022
11311532 September 18, 2038 001 No U-3055 May 17, 2022
11026939 September 18, 2038 001 No U-3055 June 30, 2021
11026939 September 18, 2038 001 No U-1995 June 30, 2021
11311532 September 18, 2038 002 No U-1995 May 17, 2022
11311532 September 18, 2038 002 No U-3055 May 17, 2022
11026939 September 18, 2038 002 No U-3055 June 30, 2021
11026939 September 18, 2038 002 No U-1995 June 30, 2021
11311532 September 18, 2038 003 No U-1995 May 17, 2022
11311532 September 18, 2038 003 No U-3055 May 17, 2022
11026939 September 18, 2038 003 No U-3055 June 30, 2021
11026939 September 18, 2038 003 No U-1995 June 30, 2021
11654142 November 14, 2038 001 No U-3055 September 14, 2023
11654142 November 14, 2038 002 No U-3055 September 14, 2023
11654142 November 14, 2038 003 No U-3055 September 14, 2023
11026931 August 14, 2039 001 No U-1995 June 30, 2021
11026931 August 14, 2039 002 No U-1995 June 30, 2021
11026931 August 14, 2039 003 No U-1995 June 30, 2021
10940141 August 10, 2040 001 No U-1995 April 6, 2021
10940141 August 10, 2040 002 No U-1995 April 6, 2021
10940141 August 10, 2040 003 No U-1995 May 19, 2021
Regulatory exclusivity periods.
Code Expires Product
I-925 August 18, 2026 001
I-925 August 18, 2026 002
I-925 August 18, 2026 003
ODE-440 August 18, 2030 001
ODE-440 August 18, 2030 002
ODE-440 August 18, 2030 003

Approval history

Source: Drugs@FDA
Most recent submissions on application 209241.
Type No. Action Status Date Review
Supplement 29 Labeling Approved February 4, 2025 Standard
Supplement 28 Labeling Approved November 22, 2024 Standard
Supplement 26 Efficacy Approved August 18, 2023 Standard
Supplement 24 Manufacturing (CMC) Approved August 11, 2022 Standard
Supplement 20 Efficacy Approved April 23, 2021 Standard
Supplement 16 Labeling Approved April 9, 2020 Standard
Supplement 12 Labeling Approved July 15, 2019 901 Required
Supplement 6 Manufacturing (CMC) Approved January 10, 2019 N/A
Supplement 3 Labeling Approved August 10, 2018 Standard
Original application 1 Type 1 - New Molecular Entity Approved April 11, 2017 Priority

Review documents

  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · December 6, 2024
  • 0 · Supplement · December 5, 2024
  • 0 · Supplement · August 22, 2023
  • 0 · Supplement · August 21, 2023
  • 0 · Supplement · November 2, 2022
  • 0 · Supplement · June 28, 2022
  • 0 · Supplement · April 28, 2021
  • 0 · Supplement · April 27, 2021
  • 0 · Supplement · April 21, 2020
  • 0 · Supplement · April 10, 2020
  • 0 · Supplement · August 5, 2019
  • 0 · Supplement · July 16, 2019
  • 0 · Supplement · August 30, 2018
  • 0 · Supplement · August 20, 2018
  • 0 · Original application · June 1, 2017
  • 0 · Original application · June 1, 2017
  • 0 · Original application · April 12, 2017
  • 0 · Original application · April 12, 2017

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
70370-2046-1 70370-2046 Neurocrine Biosciences, Inc. 1 BLISTER PACK in 1 CARTON (70370-2046-1) / 1 KIT in 1 BLISTER PACK August 18, 2023
70370-2048-6 70370-2048 Neurocrine Biosciences, Inc. 1 BLISTER PACK in 1 CARTON (70370-2048-6) / 1 KIT in 1 BLISTER PACK December 14, 2018
70370-2046 70370-2046 Neurocrine Biosciences, Inc. — August 18, 2023
70370-2048 70370-2048 Neurocrine Biosciences, Inc. — December 14, 2018

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.