Is there a generic for Brexpiprazole?

Yes. The FDA Orange Book lists 12 approved generic (ANDA) applications for Brexpiprazole, referencing the brand REXULTI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Brexpiprazole?

REXULTI (NDA 205422, OTSUKA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Brexpiprazole?

The Orange Book lists 12 patents against Brexpiprazole products, with the earliest listed expiry in 2026. 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 Brexpiprazole have FDA marketing exclusivity?

Yes. The Orange Book records 30 marketing-exclusivity periods for Brexpiprazole. 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 Brexpiprazole are approved?

Brexpiprazole is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Brexpiprazole

Brexpiprazole is approved as 1 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:REXULTI · NDA 205422

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
REXULTIRLD×6	OTSUKA	NDA 205422	AB	Jul 10, 2015

Generic (ANDA) products (12)

Product	Applicant	Application	TE	Approved
BREXPIPRAZOLE×5	APOTEX	ANDA 213731	—	Feb 24, 2025
BREXPIPRAZOLE×6	ALEMBIC	ANDA 213683	AB	Jan 13, 2025
BREXPIPRAZOLE×6	ALKEM LABS LTD	ANDA 213782	—	Nov 28, 2023
BREXPIPRAZOLE×6	HETERO LABS LTD V	ANDA 213669	—	Nov 20, 2023
BREXPIPRAZOLE×6	AUROBINDO PHARMA LTD	ANDA 213659	—	Nov 02, 2023
BREXPIPRAZOLE×6	CHARTWELL RX	ANDA 213758	—	Oct 25, 2023
BREXPIPRAZOLE×6	LUPIN	ANDA 213512	—	Mar 17, 2023
BREXPIPRAZOLE×6	AJANTA PHARMA LTD	ANDA 213718	—	Feb 03, 2023
BREXPIPRAZOLE×6	AMNEAL	ANDA 213562	—	Jan 31, 2023
BREXPIPRAZOLE×6	ZYDUS PHARMS	ANDA 213660	—	Jan 10, 2023
BREXPIPRAZOLE×6	SANDOZ	ANDA 213570	—	Sep 26, 2022
BREXPIPRAZOLE×6	TEVA PHARMS USA INC	ANDA 213692	—	Aug 11, 2022

Marketing exclusivity (30)

I-913New indication exclusivity (3 years)
May 10, 2026
1 mo ago
M-14New use / labeling-change exclusivity (3 years)
May 08, 2027
in 11 mo
M-315New use / labeling-change exclusivity (3 years)
May 09, 2028
in 1 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 10, 2026
in 5 mo
I-913New indication exclusivity (3 years)
May 10, 2026
1 mo ago
M-14New use / labeling-change exclusivity (3 years)
May 08, 2027
in 11 mo
M-315New use / labeling-change exclusivity (3 years)
May 09, 2028
in 1 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 10, 2026
in 5 mo
I-913New indication exclusivity (3 years)
May 10, 2026
1 mo ago
M-14New use / labeling-change exclusivity (3 years)
May 08, 2027
in 11 mo
M-315New use / labeling-change exclusivity (3 years)
May 09, 2028
in 1 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 10, 2026
in 5 mo
I-913New indication exclusivity (3 years)
May 10, 2026
1 mo ago
M-14New use / labeling-change exclusivity (3 years)
May 08, 2027
in 11 mo
M-315New use / labeling-change exclusivity (3 years)
May 09, 2028
in 1 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 10, 2026
in 5 mo
I-913New indication exclusivity (3 years)
May 10, 2026
1 mo ago
M-14New use / labeling-change exclusivity (3 years)
May 08, 2027
in 11 mo
M-315New use / labeling-change exclusivity (3 years)
May 09, 2028
in 1 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 10, 2026
in 5 mo
I-913New indication exclusivity (3 years)
May 10, 2026
1 mo ago
M-14New use / labeling-change exclusivity (3 years)
May 08, 2027
in 11 mo
M-315New use / labeling-change exclusivity (3 years)
May 09, 2028
in 1 yr 11 mo
PEDPediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
PEDPediatric exclusivity (adds 6 months)
Nov 10, 2026
in 5 mo

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9839637	Apr 12, 2026	2 mo ago	ProductU-1529
8618109	Apr 12, 2026	2 mo ago	U-543
8349840	Apr 12, 2026	2 mo ago	ProductU-1529
7888362	Apr 12, 2026	2 mo ago	SubstanceDelisted
9839637*PED	Oct 12, 2026	in 4 mo
8618109*PED	Oct 12, 2026	in 4 mo
7888362*PED	Oct 12, 2026	in 4 mo
8349840*PED	Oct 12, 2026	in 4 mo
RE48059	Dec 23, 2028	in 2 yr 7 mo	Substance
RE48059*PED	Jun 23, 2029	in 3 yr 1 mo
10307419	Oct 12, 2032	in 6 yr 5 mo	Product
10307419*PED	Apr 12, 2033	in 6 yr 11 mo

Brexpiprazole — frequently asked questions

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

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