Drug
Who makes brexpiprazole?
3 companies list brexpiprazole as a human prescription drug, including under the names Rexulti. Forms: kit; tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing brexpiprazole
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Otsuka America Pharmaceutical, Inc.Japan | kit; tablet | NDANDA205422 | 8 | 6 |
| Ajanta Pharma LimitedIndia | tablet | ANDAANDA213718 | 6 | 2 |
| RemedyRepack, IncUnited States | tablet | NDANDA205422 | 2 | 1 |
Bulk ingredient listings
- Aurobindo Pharma LimitedIndia · 1 NDC
- Honour Lab LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- Otsuka America Pharmaceutical, Inc.Japan · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Sionc Pharmaceuticals Private LimitedIndia · 1 NDC
- TAPI Croatia industries d.o.o.Croatia · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
Orange Book patents
7 unexpired patents list brexpiprazole as the active ingredient, expiring between Oct 2026 and Apr 2033. Application holder: OTSUKA PHARMACEUTICAL CO LTD.
Enquiry
Common questions
- Who makes brexpiprazole?
- 3 companies list brexpiprazole as a human prescription drug in the openFDA NDC Directory, led by Otsuka America Pharmaceutical, Inc., Ajanta Pharma Limited, RemedyRepack, Inc. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Rexulti?
- 1 company lists brexpiprazole under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies brexpiprazole active ingredient?
- 10 companies list brexpiprazole as a bulk ingredient, including Aurobindo Pharma Limited, Honour Lab Limited, Jubilant Biosys Limited, MSN Life Sciences Private Limited.