Orange Book product · Brand (NDA)

REXULTI

BREXPIPRAZOLE

Brand (NDA)NDA 205422TE ABRX OTSUKA

View BREXPIPRAZOLE family Open on FDA Orange Book

At a glance

Jul 10, 2015

Approved

Brand (NDA)

Application

TE code

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jul 10, 2015
11 yr 1 mo ago
Patent 7888362 expires
Listed drug substance patent expiration.
Apr 12, 2026
2 mo ago
Patent 8349840 expires
Listed drug product patent expiration.
Apr 12, 2026
2 mo ago
Patent 8618109 expires
Listed method-of-use patent (U-543) expiration.
Apr 12, 2026
2 mo ago
Patent 8618109 expires
Listed method-of-use patent (U-3281) expiration.
Apr 12, 2026
2 mo ago
Patent 9839637 expires
Listed drug product patent expiration.
Apr 12, 2026
2 mo ago
Patent 9839637 expires
Listed drug product patent expiration.
Apr 12, 2026
2 mo ago
Patent 9839637 expires
Listed drug product patent expiration.
Apr 12, 2026
2 mo ago
Exclusivity ends · I-913
New indication exclusivity (3 years)
May 10, 2026
1 mo ago
Today
Patent 7888362*PED expires
Listed listed patent expiration.
Oct 12, 2026
in 4 mo
Patent 8349840*PED expires
Listed listed patent expiration.
Oct 12, 2026
in 4 mo
Patent 8618109*PED expires
Listed listed patent expiration.
Oct 12, 2026
in 4 mo
Patent 9839637*PED expires
Listed listed patent expiration.
Oct 12, 2026
in 4 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Nov 10, 2026
in 5 mo
Exclusivity ends · M-14
New use / labeling-change exclusivity (3 years)
May 08, 2027
in 11 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Nov 08, 2027
in 1 yr 5 mo
Exclusivity ends · M-315
New use / labeling-change exclusivity (3 years)
May 09, 2028
in 1 yr 11 mo
Patent RE48059 expires
Listed drug substance patent expiration.
Dec 23, 2028
in 2 yr 7 mo
Patent RE48059*PED expires
Listed listed patent expiration.
Jun 23, 2029
in 3 yr 1 mo
Patent 10307419 expires
Listed drug product patent expiration.
Oct 12, 2032
in 6 yr 5 mo
Patent 10307419*PED expires
Listed listed patent expiration.
Apr 12, 2033
in 6 yr 11 mo

Pharmaceutical detail

Active ingredient

BREXPIPRAZOLE

Strength

0.25MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 205422

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (5)

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

Listed patents (15)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7888362	Apr 12, 2026	2 mo ago	SubstanceDelisted
8349840	Apr 12, 2026	2 mo ago	ProductU-1529
8618109	Apr 12, 2026	2 mo ago	U-543
8618109	Apr 12, 2026	2 mo ago	U-3281
9839637	Apr 12, 2026	2 mo ago	ProductU-1529
9839637	Apr 12, 2026	2 mo ago	ProductU-3281
9839637	Apr 12, 2026	2 mo ago	ProductU-543
7888362*PED	Oct 12, 2026	in 4 mo
8349840*PED	Oct 12, 2026	in 4 mo
8618109*PED	Oct 12, 2026	in 4 mo
9839637*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

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