Is there a generic for Cariprazine hydrochloride?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Cariprazine hydrochloride, referencing the brand VRAYLAR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Cariprazine hydrochloride?

VRAYLAR (NDA 204370, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Cariprazine hydrochloride?

The Orange Book lists 10 patents against Cariprazine hydrochloride products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Cariprazine hydrochloride have FDA marketing exclusivity?

Yes. The Orange Book records 22 marketing-exclusivity periods for Cariprazine hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Cariprazine hydrochloride are approved?

Cariprazine hydrochloride is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Cariprazine hydrochloride

Cariprazine hydrochloride: 1 brand, 3 generics; first approved Sep 17, 2015; generic available.

Generic available22 exclusivity periodsHas discontinued products

Generic status & protection

Generic available — 3 ANDA applications approved.

Earliest patent expiry Dec 16, 2028Latest exclusivity ends Jun 18, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 16, 2028

in 2 yr 6 mo

Originator applications

Brand (NDA) products

VRAYLARRLD

ABBVIENDA 20437020256 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1.5MG BASE	CAPSULE	ORAL	Rx	—
EQ 3MG BASE	CAPSULE	ORAL	Rx	—
EQ 4.5MG BASE	CAPSULE	ORAL	Rx	—
EQ 6MG BASE	CAPSULE	ORAL	Rx	—
EQ 0.5MG BASE	CAPSULE	ORAL	Rx	—
EQ 0.75MG BASE	CAPSULE	ORAL	Rx	—

Abbreviated applications

Generic (ANDA) products (3)

CARIPRAZINE HYDROCHLORIDE

AUROBINDO PHARMA LTDANDA 21398220253 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1.5MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 3MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 6MG BASE	CAPSULE	ORAL	Discontinued	—

CARIPRAZINE HYDROCHLORIDE

SUN PHARMANDA 21393220224 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1.5MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 3MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 4.5MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 6MG BASE	CAPSULE	ORAL	Discontinued	—

CARIPRAZINE HYDROCHLORIDE

ZYDUSANDA 21398420224 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1.5MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 3MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 4.5MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 6MG BASE	CAPSULE	ORAL	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (22)

M-14New use / labeling-change exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
NPPNew patient population exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr
PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr
M-14New use / labeling-change exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
NPPNew patient population exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr
PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr
M-14New use / labeling-change exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
NPPNew patient population exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr
PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr
M-14New use / labeling-change exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
NPPNew patient population exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr
PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr
M-14New use / labeling-change exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
NPPNew patient population exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr
PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr
M-14New use / labeling-change exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr

Orange Book patent file

Listed patents

Listed patents (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7943621	Dec 20, 2028	in 2 yr 6 mo	SubstanceProduct
7943621*PED	Jun 20, 2029	in 3 yr
RE49110	Jul 16, 2029	in 3 yr 1 mo	U-2543
RE47350	Jul 16, 2029	in 3 yr 1 mo	U-2543
RE49302	Jul 16, 2029	in 3 yr 1 mo	U-2543
7737142	Sep 17, 2029	in 3 yr 3 mo	SubstanceProductU-2543
RE49110*PED	Jan 16, 2030	in 3 yr 7 mo
RE47350*PED	Jan 16, 2030	in 3 yr 7 mo
RE49302*PED	Jan 16, 2030	in 3 yr 7 mo
7737142*PED	Mar 17, 2030	in 3 yr 9 mo

FDA approval span

Approval history

First approval

Sep 17, 2015

11 yr ago

Most recent approval

Dec 18, 2025

7 mo ago

Approvals span 2015–2025 across 4 FDA applications.

Brand (NDA) 125%

Generic (ANDA) 375%

Cariprazine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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