Register entry
Kyowa Kirin Co., Ltd.
- Registered sites
- 1
- Drug products
- 11
- Live patents
- 4
- 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 manufacture
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Kyowa Kirin Co., Ltd. | Takasaki-shiJapan | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3007588904 |
Exclusivity
Patents
4Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| NOURIANZ | ISTRADEFYLLINE | Sept 2027 |
| NOURIANZ | ISTRADEFYLLINE | Jan 2028 |
Catalogue
Marketed products
11Showing 11 of 11.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| CRYSVITA | Burosumab | INJECTION | BLA |
| CRYSVITA | Burosumab | INJECTION | BLA |
| CRYSVITA | Burosumab | INJECTION | BLA |
| Fareston | toremifene citrate | TABLET | NDA |
| NOURIANZ | istradefylline | TABLET, FILM COATED | NDA |
| NOURIANZ | istradefylline | TABLET, FILM COATED | NDA |
| POTELIGEO | mogamulizumab-kpkc | INJECTION | BLA |
| - | burosumab | INJECTION | DRUG FOR FURTHER PROCESSING |
| - | burosumab | INJECTION | DRUG FOR FURTHER PROCESSING |
| - | burosumab | INJECTION | DRUG FOR FURTHER PROCESSING |
| - | mogamulizumab | INJECTION | DRUG FOR FURTHER PROCESSING |
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.