Register entry
Otsuka America Pharmaceutical, Inc.
Data as of · How to read this entry
- Registered sites
- 6
- Active NDC listings
- 62
- Labeller names
- 4
- Live patents
- 236
- Exclusivities
- 1
- Countries
- 1
- Base
- Japan
Authorisation
Registered operations
Analytical testing6Active ingredient (API) manufacture2Finished drug manufacture5Packaging2
Sites
Registered establishments
6| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Otsuka Pharmaceutical Co LtdRegistrant: Otsuka America Pharmaceutical, Inc. | Matsudani, Itano-cho, Itano-gun, Tokushima 779-0112, Japan (JPN) | Analytical testing, Finished drug manufacture | 3003656524694877866 |
| Otsuka Pharmaceutical Co., Ltd.Registrant: Otsuka America Pharmaceutical, Inc. | AZAHIGASHIYAMA5006-5, OMAGARI, YOSHINOGARICHO, Kanzaki-gun, Saga 842-0103, Japan (JPN) | Analytical testing, Active ingredient (API) manufacture | 3003808559695314260 |
| Otsuka Pharmaceutical Co LtdRegistrant: Otsuka America Pharmaceutical, Inc. | 1-3, MIMACHOSATOHIRANO, Mima, Tokushima 771-2106, Japan (JPN) | Analytical testing, Finished drug manufacture, Packaging | 3017406106718129326 |
| Otsuka Pharmaceutical Co LtdRegistrant: Otsuka America Pharmaceutical, Inc. | AZAOTSUBO306-2, KONIU, NAKACHO, Naka-gun, Tokushima 771-5209, Japan (JPN) | Analytical testing, Finished drug manufacture, Packaging | 3004810250695314294 |
| Otsuka Pharmaceutical Co LtdRegistrant: Otsuka America Pharmaceutical, Inc. | HIRAISHIEBISUNO224-18, KAWAUCHICHO, Tokushima, TOKUSHIMA 771-0132, Japan (JPN) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3002807834695733295 |
| Otsuka Pharmaceutical Co LtdRegistrant: Otsuka America Pharmaceutical, Inc. | KAGASUNO463-10, KAWAUCHICHO, Tokushima, TOKUSHIMA 771-0130, Japan (JPN) | Analytical testing, Finished drug manufacture | 3002809299695314484 |
Catalogue
Drug listings by form and route
6262 active NDC listings: 31 human prescription drug, 30 drug for further processing, 1 bulk ingredient. By marketing category: DRUG FOR FURTHER PROCESSING 30, NDA 30, BLA 1, BULK INGREDIENT 1.
| Dosage form | NDCs |
|---|---|
| tablet | 40 |
| kit | 11 |
| injection, powder, lyophilized, for suspension, extended release | 4 |
| injection, suspension, extended release | 4 |
| capsule, gelatin coated | 1 |
| injection | 1 |
| powder | 1 |
| Route | NDCs |
|---|---|
| oral | 17 |
| intramuscular | 2 |
| subcutaneous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| otsuka pharmaceutical co., ltd. | 30 |
| otsuka america pharmaceutical, inc. | 28 |
| otsuka america pharmaceutical, inc | 3 |
| otsuka pharmaceutical co. ltd. | 1 |
Exclusivity
Patents and exclusivities
236| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8349840*PED | REXULTIbrexpiprazole | use | Oct 2026 |
| 8618109*PED | REXULTIbrexpiprazole | use | Oct 2026 |
| 9839637*PED | REXULTIbrexpiprazole | use | Oct 2026 |
| 8759350 | ABILIFY, ABILIFY MYCITE KITaripiprazole | use | Mar 2027 |
| 9444503 | ABILIFY MYCITE KITaripiprazole | product | Nov 2027 |
| 9119554 | ABILIFY MYCITE KITaripiprazole | product | Dec 2028 |
| RE48059 | REXULTIbrexpiprazole | substance | Dec 2028 |
| 9060708 | ABILIFY MYCITE KITaripiprazole | product | Mar 2029 |
| 9258035 | ABILIFY MYCITE KITaripiprazole | product | Mar 2029 |
| 8674825 | ABILIFY MYCITE KITaripiprazole | product | Apr 2029 |
| RE48059*PED | REXULTIbrexpiprazole | use | Jun 2029 |
| 8956288 | ABILIFY MYCITE KITaripiprazole | product | Jul 2029 |
| 10441194 | ABILIFY MYCITE KITaripiprazole | product | Jul 2029 |
| 8945005 | ABILIFY MYCITE KITaripiprazole | product | Aug 2029 |
| 9433371 | ABILIFY MYCITE KITaripiprazole | product | Sept 2029 |
| 8718193 | ABILIFY MYCITE KITaripiprazole | product | Dec 2029 |
| 9149577 | ABILIFY MYCITE KITaripiprazole | product | Dec 2029 |
| 8847766 | ABILIFY MYCITE KITaripiprazole | product | Mar 2030 |
| 10905694 | JYNARQUE, SAMSCAtolvaptan | product | Apr 2030 |
| 8545402 | ABILIFY MYCITE KITaripiprazole | product | Apr 2030 |
| 8114021 | ABILIFY MYCITE KITaripiprazole | product | Jun 2030 |
| 11464423 | ABILIFY MYCITE KITaripiprazole | product | Sept 2030 |
| 9941931 | ABILIFY MYCITE KITaripiprazole | product | Nov 2030 |
| 8961412 | ABILIFY MYCITE KITaripiprazole | product | Nov 2030 |
| 8258962 | ABILIFY MYCITE KITaripiprazole | product | Nov 2030 |
| 8547248 | ABILIFY MYCITE KITaripiprazole | product | Dec 2030 |
| 11229378 | ABILIFY MYCITE KITaripiprazole | product | Jul 2031 |
| 9320455 | ABILIFY MYCITE KITaripiprazole | product | Dec 2031 |
| 10517507 | ABILIFY MYCITE KITaripiprazole | product | Jun 2032 |
| 10307419 | REXULTIbrexpiprazole | product | Oct 2032 |
| 10307419*PED | REXULTIbrexpiprazole | use | Apr 2033 |
| 10517951 | ABILIFY ASIMTUFIIaripiprazole | product | Apr 2033 |
| 11097007 | ABILIFY ASIMTUFIIaripiprazole | product | Apr 2033 |
| 11638757 | ABILIFY ASIMTUFIIaripiprazole | product | Apr 2033 |
| 12016927 | ABILIFY ASIMTUFIIaripiprazole | product | Apr 2033 |
| 10980803 | ABILIFY MAINTENA KITaripiprazole | use | Sept 2033 |
| 11154553 | ABILIFY MAINTENA KITaripiprazole | use | Sept 2033 |
| 11344547 | ABILIFY MAINTENA KITaripiprazole | use | Sept 2033 |
| 11400087 | ABILIFY MAINTENA KITaripiprazole | use | Sept 2033 |
| 9268909 | ABILIFY MYCITE KITaripiprazole | product | Oct 2033 |
| 10525057 | ABILIFY MAINTENA KITaripiprazole | use | Mar 2034 |
| 11648347 | ABILIFY MAINTENA KITaripiprazole | product | Apr 2034 |
| 12691056 | ABILIFY MAINTENA KITaripiprazole | use | Apr 2041 |
| Product | Exclusivity | Until |
|---|---|---|
| REXULTIBREXPIPRAZOLE | M-315 Miscellaneous | May 2028 |
Catalogue
Marketed products
62| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ABILIFY | ARIPIPRAZOLE | tablet, oral | 59148-006NDA |
| ABILIFY | ARIPIPRAZOLE | tablet, oral | 59148-007NDA |
| ABILIFY | ARIPIPRAZOLE | tablet, oral | 59148-008NDA |
| ABILIFY | ARIPIPRAZOLE | tablet, oral | 59148-009NDA |
| ABILIFY | ARIPIPRAZOLE | tablet, oral | 59148-010NDA |
| ABILIFY | ARIPIPRAZOLE | tablet, oral | 59148-011NDA |
| ABILIFY MAINTENA | aripiprazole | kit | 59148-045NDA |
| ABILIFY MAINTENA | aripiprazole | kit | 59148-072NDA |
| ABILIFY MAINTENA | aripiprazole | kit | 59148-232NDA |
| ABILIFY MAINTENA | aripiprazole | kit | 59148-245NDA |
| - | ARIPIPRAZOLE | tablet | 46602-0006DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | tablet | 46602-0007DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | tablet | 46602-0008DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | tablet | 46602-0009DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | tablet | 46602-0010DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | tablet | 46602-0011DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | tablet | 46602-1029DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | tablet | 46602-1030DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | tablet | 46602-1031DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | tablet | 46602-1032DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | tablet | 46602-1033DRUG FOR FURTHER PROCESSING |
| - | ARIPIPRAZOLE | tablet | 46602-1034DRUG FOR FURTHER PROCESSING |
| Abilify Asimtufii | Aripiprazole | injection, suspension, extended release, intramuscular | 59148-102NDA |
| Abilify Asimtufii | Aripiprazole | injection, suspension, extended release, intramuscular | 59148-114NDA |
| - | Aripiprazole | injection, suspension, extended release | 46602-0102DRUG FOR FURTHER PROCESSING |
| - | Aripiprazole | injection, suspension, extended release | 46602-0114DRUG FOR FURTHER PROCESSING |
| - | BREXPIPRAZOLE | tablet | 46602-0035DRUG FOR FURTHER PROCESSING |
| - | BREXPIPRAZOLE | tablet | 46602-0036DRUG FOR FURTHER PROCESSING |
| - | BREXPIPRAZOLE | tablet | 46602-0037DRUG FOR FURTHER PROCESSING |
| - | BREXPIPRAZOLE | tablet | 46602-0038DRUG FOR FURTHER PROCESSING |
| - | BREXPIPRAZOLE | tablet | 46602-0039DRUG FOR FURTHER PROCESSING |
| - | BREXPIPRAZOLE | tablet | 46602-0040DRUG FOR FURTHER PROCESSING |
| - | Cedazuridine and Decitabine | tablet | 46602-0112DRUG FOR FURTHER PROCESSING |
| JYNARQUE | tolvaptan | tablet, oral | 59148-082NDA |
| JYNARQUE | tolvaptan | tablet, oral | 59148-083NDA |
| Jynarque | tolvaptan | kit | 59148-079NDA |
| Jynarque | tolvaptan | kit | 59148-080NDA |
| Jynarque | tolvaptan | kit | 59148-087NDA |
| Jynarque | tolvaptan | kit | 59148-088NDA |
| Jynarque | tolvaptan | kit | 59148-089NDA |
| Nuedexta | dextromethorphan hydrobromide and quinidine sulfate | capsule, gelatin coated, oral | 59148-053NDA |
| Rexulti | brexpiprazole | tablet, oral | 59148-035NDA |
| Rexulti | brexpiprazole | tablet, oral | 59148-036NDA |
| Rexulti | brexpiprazole | tablet, oral | 59148-037NDA |
| Rexulti | brexpiprazole | tablet, oral | 59148-038NDA |
| Rexulti | brexpiprazole | tablet, oral | 59148-039NDA |
| Rexulti | brexpiprazole | tablet, oral | 59148-040NDA |
| Rexulti | BREXPIPRAZOLE | kit | 59148-042NDA |
| Rexulti | BREXPIPRAZOLE | kit | 59148-044NDA |
| SAMSCA | tolvaptan | tablet, oral | 59148-020NDA |
| SAMSCA | tolvaptan | tablet, oral | 59148-021NDA |
| - | Tolvaptan | tablet | 46602-0027DRUG FOR FURTHER PROCESSING |
| - | Tolvaptan | tablet | 46602-0028DRUG FOR FURTHER PROCESSING |
| - | Tolvaptan | tablet | 46602-0029DRUG FOR FURTHER PROCESSING |
| - | Tolvaptan | tablet | 46602-0030DRUG FOR FURTHER PROCESSING |
| - | Tolvaptan | tablet | 46602-0031DRUG FOR FURTHER PROCESSING |
| VOYXACT | sibeprenlimab | injection, subcutaneous | 59148-400BLA |
| - | aripiprazole | injection, powder, lyophilized, for suspension, extended release | 46602-0025DRUG FOR FURTHER PROCESSING |
| - | aripiprazole | injection, powder, lyophilized, for suspension, extended release | 46602-0026DRUG FOR FURTHER PROCESSING |
| - | aripiprazole | injection, powder, lyophilized, for suspension, extended release | 46602-0045DRUG FOR FURTHER PROCESSING |
| - | aripiprazole | injection, powder, lyophilized, for suspension, extended release | 46602-0072DRUG FOR FURTHER PROCESSING |
| - | brexpiprazole | powder | 46602-0001BULK INGREDIENT |
Neighbours
Registered in the same town
3- Shionogi Pharma Co., Ltd.Tokushima, JPN
- Taiho Oncology, Inc.Itano-gun, JPN
- Otsuka Chemical Co., Ltd.Tokushima, JPN
Compare
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- Terumo Pharmaceutical Services GmbH4 sites · 12 NDC
- Ajinomoto Health & Nutrition North America, Inc.9 sites · 20 NDC
- Chugai Pharmaceutical Co., Ltd.3 sites · 13 NDC
- Daiichi Sankyo Europe GmbH3 sites · 11 NDC
- Sumitomo Chemical Company, Limited3 sites · 8 NDC
- Meiji Seika Pharma Co., Ltd.3 sites · 1 NDC
- Sumitomo Pharma Co., Ltd.2 sites · 24 NDC
- TAYCA CORPORATION2 sites · 22 NDC
Enquiry
Common questions
- Is Otsuka America Pharmaceutical, Inc. FDA approved?
- Otsuka America Pharmaceutical, Inc. holds 6 FDA-registered establishments in Japan. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Otsuka America Pharmaceutical, Inc.'s drugs manufactured?
- The FDA register lists Itano-gun; Kanzaki-gun; Mima; Naka-gun; Tokushima. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging.
- What drugs does Otsuka America Pharmaceutical, Inc. make?
- 62 products are listed under Otsuka America Pharmaceutical, Inc. in the openFDA NDC Directory, most often as tablet; kit; injection, powder, lyophilized, for suspension, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.