FDA Orange Book · active-ingredient family
Brexpiprazole
Brexpiprazole: 1 brand, 12 generics; first approved Jul 10, 2015; generic available.
Generic available30 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
12
Listed patents
10
Next patent expiry
Apr 12, 2026
4 mo ago
Brand (NDA) products
Originator applications
- REXULTIRLDOTSUKANDA 20542220156 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Rx AB 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 3MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB
Generic (ANDA) products (12)
Abbreviated applications
- BREXPIPRAZOLEAPOTEXANDA 21373120255 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — - BREXPIPRAZOLEALEMBICANDA 21368320256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Rx AB 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 3MG TABLET ORAL Rx AB 4MG TABLET ORAL Rx AB - BREXPIPRAZOLEALKEM LABS LTDANDA 21378220236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — - BREXPIPRAZOLEHETERO LABS LTD VANDA 21366920236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — - BREXPIPRAZOLEAUROBINDO PHARMA LTDANDA 21365920236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — - BREXPIPRAZOLECHARTWELL RXANDA 21375820236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — - BREXPIPRAZOLELUPINANDA 21351220236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — - BREXPIPRAZOLEAJANTA PHARMA LTDANDA 21371820236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — - BREXPIPRAZOLEAMNEALANDA 21356220236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — - BREXPIPRAZOLEZYDUS PHARMSANDA 21366020236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — - BREXPIPRAZOLESANDOZANDA 21357020226 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — - BREXPIPRAZOLETEVA PHARMS USA INCANDA 21369220226 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- I-913New indication exclusivity (3 years)
3 mo ago
- M-14New use / labeling-change exclusivity (3 years)
in 9 mo
- M-315New use / labeling-change exclusivity (3 years)
in 1 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
in 3 mo
- I-913New indication exclusivity (3 years)
3 mo ago
- M-14New use / labeling-change exclusivity (3 years)
in 9 mo
- M-315New use / labeling-change exclusivity (3 years)
in 1 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
in 3 mo
- I-913New indication exclusivity (3 years)
3 mo ago
- M-14New use / labeling-change exclusivity (3 years)
in 9 mo
- M-315New use / labeling-change exclusivity (3 years)
in 1 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
in 3 mo
- I-913New indication exclusivity (3 years)
3 mo ago
- M-14New use / labeling-change exclusivity (3 years)
in 9 mo
- M-315New use / labeling-change exclusivity (3 years)
in 1 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
in 3 mo
- I-913New indication exclusivity (3 years)
3 mo ago
- M-14New use / labeling-change exclusivity (3 years)
in 9 mo
- M-315New use / labeling-change exclusivity (3 years)
in 1 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
in 3 mo
- I-913New indication exclusivity (3 years)
3 mo ago
- M-14New use / labeling-change exclusivity (3 years)
in 9 mo
- M-315New use / labeling-change exclusivity (3 years)
in 1 yr 9 mo
- PEDPediatric exclusivity (adds 6 months)
in 1 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
in 3 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9839637 | 4 mo ago | ProductU-1529 | |
| 8618109 | 4 mo ago | U-543 | |
| 8349840 | 4 mo ago | ProductU-1529 | |
| 9839637*PED | in 2 mo | ||
| 8618109*PED | in 2 mo | ||
| 8349840*PED | in 2 mo | ||
| RE48059 | in 2 yr 5 mo | Substance | |
| RE48059*PED | in 2 yr 11 mo | ||
| 10307419 | in 6 yr 3 mo | Product | |
| 10307419*PED | in 6 yr 9 mo |
Approval history
FDA approval span
First approval
11 yr 3 mo ago
Most recent approval
1 yr 6 mo ago
Approvals span 2015–2025 across 13 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1292%
Brexpiprazole: 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
