Viewing data from:

VRAYLAR

NDA

CARIPRAZINE HYDROCHLORIDE | N204370 | ABBVIE INC

6 strengths5 unique patents3 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayPED (+6 mo)Exclusivity

2027

2028

2029

2030

Today

Jan. 16, 2030

Jan. 16, 2030

Jan. 16, 2030

Mar. 17, 2030

Jun. 16, 2029

M-14

Jun. 18, 2029

NPP

Jun. 18, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
AbbVie Inc. et al v. Deva Holding A.S. 1:2025cv01332 5 patentsANDA 219532cariprazine	D. Del.	2025-10-30	Active	—
Allergan USA, Inc. et al v. Aurobindo Pharma Limited et al 1:2019cv02317 2 patentsANDA 213932, 213982, 213984cariprazine	D. Del.	2019-12-20	Terminated 2022-06-01	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from HQ Pharma (Shanghai) Co., Ltd. FDA-2026-P-2443 · 5 docket documents HQ Pharma (Shanghai) Co., Ltd. filed this citizen petition under Section 505(j)(2)(C) of the FD&C Act requesting that the FDA revise the Draft Guidance on Cariprazine Hydrochloride (RLD number 204370) to include product-specific guidance for cariprazine hydrochloride capsules at 0.5 mg and 0.75 mg s	Other	2026-03-10	Denied	HQ Pharma (Shanghai) Co., Ltd.
Suitability Petition from HQ Pharma (Shanghai) Co., Ltd. FDA-2025-P-0332 · 6 docket documents HQ Pharma (Shanghai) Co., Ltd. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to pursue an Abbreviated New Drug Application for cariprazine hydrochloride orally disintegrating tablets in strengths of 1.5 mg, 3 mg, 4.5 mg,	Suitability	2025-01-23	Denied	HQ Pharma (Shanghai) Co., Ltd.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

27 trials from ClinicalTrials.gov — 1 recruiting, 24 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia NCT03817502	Phase 3	Recruiting	Gedeon Richter Plc.	330	2019-06-06 → 2026-12-15
Safety and Efficacy of Cariprazine in Patients With Schizophrenia NCT01104766	Phase 3	Completed	Forest Laboratories	617	2010-04-23 → 2011-12-20
Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder NCT00854100	Phase 2	Completed	Forest Laboratories	231	2009-06-30 → 2010-12-06
Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder NCT01469377	Phase 2	Completed	Forest Laboratories	819	2011-12-15 → 2013-12-12
Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder NCT01838876	Phase 3	Completed	Forest Laboratories	442	2013-04-29 → 2015-07-27
The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone NCT03739203	Phase 3	Completed	AbbVie	752	2018-11-10 → 2021-09-06
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)NCT01715805	Phase 3	Completed	Forest Laboratories	1,022	2012-11-15 → 2016-06-24
Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder NCT02670538	Phase 3	Completed	Forest Laboratories	493	2016-03-31 → 2018-01-18
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder NCT01059539	Phase 3	Completed	Forest Laboratories	403	2010-02-28 → 2012-02-29
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features NCT03573297	Phase 3	Completed	AbbVie	901	2018-06-15 → 2022-09-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 8 NDCs

Highest NADAC/Unit

$51.03

per ea

Lowest NADAC/Unit

$50.81

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61874027530VRAYLAR 0.75 MG CAPSULE	$51.03	EA	Brand	—	2026-06-17
61874011530VRAYLAR 1.5 MG CAPSULE	$50.92	EA	Brand	—	2026-06-17
61874011520VRAYLAR 1.5 MG CAPSULE	$50.92	EA	Brand	—	2026-06-17
61874025030VRAYLAR 0.5 MG CAPSULE	$50.89	EA	Brand	—	2026-06-17
61874013030VRAYLAR 3 MG CAPSULE	$50.88	EA	Brand	—	2026-06-17
61874013020VRAYLAR 3 MG CAPSULE	$50.88	EA	Brand	—	2026-06-17
61874014530VRAYLAR 4.5 MG CAPSULE	$50.81	EA	Brand	—	2026-06-17
61874016030VRAYLAR 6 MG CAPSULE	$50.81	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$729.73

Highest Price

$1480.71

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61874-0115-20VRAYLAR 1.5MG CAPSULE	$729.73	Big4	Abbvie US LLC	07/31/2030
61874-0115-20VRAYLAR 1.5MG CAPSULE	$987.15	FSS	Abbvie US LLC	07/31/2030
61874-0115-30VRAYLAR 1.5 MG CAPSULE	$1480.71	FSS	Abbvie US LLC	07/31/2030
61874-0115-30VRAYLAR 1.5 MG CAPSULE	$1097.47	Big4	Abbvie US LLC	07/31/2030
61874-0130-20VRAYLAR 3MG CAPSULE	$987.15	FSS	Abbvie US LLC	07/31/2030
61874-0130-20VRAYLAR 3MG CAPSULE	$732.85	Big4	Abbvie US LLC	07/31/2030

Showing 6 of 12 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Vraylar (2024)

Total Spending

$1.1B

Total Claims

766,962

Beneficiaries

117,573

Avg Cost/Unit

$48.73

Spending Trend

$305.1M(2019)→$487.5M(2020)→$583.1M(2021)→$708.8M(2022)→$935.7M(2023)→$1.1B(2024)

YoY Change:-0.2%

5yr CAGR:+3.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain16 active DMFs

14 active API suppliers hold Drug Master Files for this ingredient.

GEDEON RICHTER PLCCARIPRAZINE HYDROCHLORIDE

DMF 263212012

MSN LABORATORIES PRIVATE LTDCARIPRAZINE HYDROCHLORIDE

DMF 333992018

MAPRIMED SACARIPRAZINE HYDROCHLORIDE

DMF 336232019

SUN PHARMACEUTICAL INDUSTRIES LTDCARIPRAZINE HYDROCHLORIDE

DMF 338342019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCARIPRAZINE HYDROCHLORIDE

DMF 338462019

APITORIA PHARMA PRIVATE LTDCARIPRAZINE HYDROCHLORIDE PREMIX

DMF 339562019

LEE PHARMA LTDCARIPRAZINE HYDROCHLORIDE

DMF 387492023

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDCARIPRAZINE HYDROCHLORIDE

DMF 389332023

MAPRIMED SACARIPRAZINE

DMF 392992025

HOSTER LABS PRIVATE LTDCARIPRAZINE HYDROCHLORIDE

DMF 400292024

MEHTA API PVT LTDCARIPRAZINE HYDROCHLORIDE IH

DMF 404042024

OPTIMUS DRUGS PRIVATE LTDCARIPRAZINE HYDROCHLORIDE

DMF 411562025

QILU PHARMACEUTICAL CO LTDCARIPRAZINE HYDROCHLORIDE

DMF 413122025

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)CARIPRAZINE HYDROCHLORIDE

DMF 416572025

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCARIPRAZINE HYDROCHLORIDE (6076)

DMF 417532025

HIKAL LTDCARIPRAZINE HYDROCHLORIDE

DMF 439012026

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Dec 19, 2025	SUPPL -17	View Letter (PDF)
Dec 19, 2025	SUPPL -16	View Letter (PDF)
Dec 19, 2025	SUPPL -15	View Letter (PDF)
Dec 19, 2025	SUPPL -14	View Letter (PDF)
Nov 26, 2024	SUPPL -12	View Letter (PDF)
Dec 20, 2022	SUPPL -9	View Letter (PDF)
Jun 4, 2019	SUPPL -6	View Letter (PDF)
Dec 19, 2018	SUPPL -5	View Letter (PDF)
Nov 15, 2017	SUPPL -3	View Letter (PDF)
Nov 15, 2017	SUPPL -2	View Letter (PDF)
Mar 2, 2017	SUPPL -1	View Letter (PDF)
Sep 18, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — EQ 1.5MG BASE

RLD

5 patents3 exclusivities▴

CAPSULE;ORAL | Approved: Sep 17, 2015

Patents (5) · 18 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE47350	Jul 16, 2029PED: Jan 16, 2030	PED	—	—		—
RE49110	Jul 16, 2029PED: Jan 16, 2030	PED	—	—		—
RE49302	Jul 16, 2029PED: Jan 16, 2030	PED	—	—		—
7737142	Sep 17, 2029PED: Mar 17, 2030	PED	Yes	Yes		—
7943621	Dec 16, 2028PED: Jun 16, 2029	PED	Yes	Yes	—	—

Exclusivities (3)

Code	Date	Status
M-14	Dec 18, 2028	Active
NPP	Dec 18, 2028	Active
PED	Jun 18, 2029	Active

#002 — EQ 3MG BASE

RLD

4 patents3 exclusivities▾

CAPSULE;ORAL | Approved: Sep 17, 2015

#003 — EQ 4.5MG BASE

RLD

4 patents3 exclusivities▾

CAPSULE;ORAL | Approved: Sep 17, 2015

#004 — EQ 6MG BASE

RLD

4 patents2 exclusivities▾

CAPSULE;ORAL | Approved: Sep 17, 2015

#005 — EQ 0.5MG BASE

RLD

4 patents3 exclusivities▾

CAPSULE;ORAL | Approved: Dec 18, 2025

#006 — EQ 0.75MG BASE

RLD

4 patents3 exclusivities▾

CAPSULE;ORAL | Approved: Dec 18, 2025