Register entry
Otsuka America Pharmaceutical, Inc.
- Registered sites
- 6
- Drug products
- 62
- Live patents
- 246
- Countries
- 1
- Base
- Japan
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureFinished drug manufacturePackaging
Sites
Facilities
6| Site | Location | Operations | FEI |
|---|---|---|---|
| Otsuka Pharmaceutical Co Ltd | Itano-gunJapan | Analytical testing, Finished drug manufacture | 3003656524 |
| Otsuka Pharmaceutical Co., Ltd. | Kanzaki-gunJapan | Analytical testing, Active ingredient (API) manufacture | 3003808559 |
| Otsuka Pharmaceutical Co Ltd | MimaJapan | Analytical testing, Finished drug manufacture, Packaging | 3017406106 |
| Otsuka Pharmaceutical Co Ltd | Naka-gunJapan | Analytical testing, Finished drug manufacture, Packaging | 3004810250 |
| Otsuka Pharmaceutical Co Ltd | TokushimaJapan | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3002807834 |
| Otsuka Pharmaceutical Co Ltd | TokushimaJapan | Analytical testing, Finished drug manufacture | 3002809299 |
Exclusivity
Patents
246Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ABILIFY | ARIPIPRAZOLE | Mar 2027 |
| ABILIFY ASIMTUFII | ARIPIPRAZOLE | Apr 2033 |
| ABILIFY MAINTENA KIT | ARIPIPRAZOLE | Sept 2033 |
| ABILIFY MAINTENA KIT | ARIPIPRAZOLE | Mar 2034 |
| ABILIFY MAINTENA KIT | ARIPIPRAZOLE | Apr 2034 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Sept 2026 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Mar 2027 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Nov 2027 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Dec 2028 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Mar 2029 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Apr 2029 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Jul 2029 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Jul 2029 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Aug 2029 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Sept 2029 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Dec 2029 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Dec 2029 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Mar 2030 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Apr 2030 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Jun 2030 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Sept 2030 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Nov 2030 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Nov 2030 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Nov 2030 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Dec 2030 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Jul 2031 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Dec 2031 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Jun 2032 |
| ABILIFY MYCITE KIT | ARIPIPRAZOLE | Oct 2033 |
| JYNARQUE | TOLVAPTAN | Sept 2026 |
| JYNARQUE | TOLVAPTAN | Apr 2030 |
| REXULTI | BREXPIPRAZOLE | Oct 2026 |
| REXULTI | BREXPIPRAZOLE | Dec 2028 |
| REXULTI | BREXPIPRAZOLE | Jun 2029 |
| REXULTI | BREXPIPRAZOLE | Oct 2032 |
| REXULTI | BREXPIPRAZOLE | Apr 2033 |
| SAMSCA | TOLVAPTAN | Sept 2026 |
| SAMSCA | TOLVAPTAN | Apr 2030 |
Catalogue
Marketed products
62Showing 62 of 62.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ABILIFY | ARIPIPRAZOLE | TABLET | NDA |
| ABILIFY | ARIPIPRAZOLE | TABLET | NDA |
| ABILIFY | ARIPIPRAZOLE | TABLET | NDA |
| ABILIFY | ARIPIPRAZOLE | TABLET | NDA |
| ABILIFY | ARIPIPRAZOLE | TABLET | NDA |
| ABILIFY | ARIPIPRAZOLE | TABLET | NDA |
| ABILIFY MAINTENA | aripiprazole | KIT | NDA |
| ABILIFY MAINTENA | aripiprazole | KIT | NDA |
| ABILIFY MAINTENA | aripiprazole | KIT | NDA |
| ABILIFY MAINTENA | aripiprazole | KIT | NDA |
| - | ARIPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| Abilify Asimtufii | Aripiprazole | INJECTION, SUSPENSION, EXTENDED RELEASE | NDA |
| Abilify Asimtufii | Aripiprazole | INJECTION, SUSPENSION, EXTENDED RELEASE | NDA |
| - | Aripiprazole | INJECTION, SUSPENSION, EXTENDED RELEASE | DRUG FOR FURTHER PROCESSING |
| - | Aripiprazole | INJECTION, SUSPENSION, EXTENDED RELEASE | DRUG FOR FURTHER PROCESSING |
| - | BREXPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | BREXPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | BREXPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | BREXPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | BREXPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | BREXPIPRAZOLE | TABLET | DRUG FOR FURTHER PROCESSING |
| - | Cedazuridine and Decitabine | TABLET | DRUG FOR FURTHER PROCESSING |
| JYNARQUE | tolvaptan | TABLET | NDA |
| JYNARQUE | tolvaptan | TABLET | NDA |
| Jynarque | tolvaptan | KIT | NDA |
| Jynarque | tolvaptan | KIT | NDA |
| Jynarque | tolvaptan | KIT | NDA |
| Jynarque | tolvaptan | KIT | NDA |
| Jynarque | tolvaptan | KIT | NDA |
| Nuedexta | dextromethorphan hydrobromide and quinidine sulfate | CAPSULE, GELATIN COATED | NDA |
| Rexulti | brexpiprazole | TABLET | NDA |
| Rexulti | brexpiprazole | TABLET | NDA |
| Rexulti | brexpiprazole | TABLET | NDA |
| Rexulti | brexpiprazole | TABLET | NDA |
| Rexulti | brexpiprazole | TABLET | NDA |
| Rexulti | brexpiprazole | TABLET | NDA |
| Rexulti | BREXPIPRAZOLE | KIT | NDA |
| Rexulti | BREXPIPRAZOLE | KIT | NDA |
| SAMSCA | tolvaptan | TABLET | NDA |
| SAMSCA | tolvaptan | TABLET | NDA |
| - | Tolvaptan | TABLET | DRUG FOR FURTHER PROCESSING |
| - | Tolvaptan | TABLET | DRUG FOR FURTHER PROCESSING |
| - | Tolvaptan | TABLET | DRUG FOR FURTHER PROCESSING |
| - | Tolvaptan | TABLET | DRUG FOR FURTHER PROCESSING |
| - | Tolvaptan | TABLET | DRUG FOR FURTHER PROCESSING |
| VOYXACT | sibeprenlimab | INJECTION | BLA |
| - | aripiprazole | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE | DRUG FOR FURTHER PROCESSING |
| - | aripiprazole | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE | DRUG FOR FURTHER PROCESSING |
| - | aripiprazole | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE | DRUG FOR FURTHER PROCESSING |
| - | aripiprazole | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE | DRUG FOR FURTHER PROCESSING |
| - | brexpiprazole | POWDER | BULK INGREDIENT |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.