Register entry
Daiichi Sankyo Europe GmbH
- Registered sites
- 3
- Drug products
- 11
- Live patents
- 52
- Countries
- 2
- 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) manufactureLabellingFinished drug manufacturePackaging
Sites
Facilities
3| Site | Location | Operations | FEI |
|---|---|---|---|
| Daiichi Sankyo Europe GmbH | Pfaffenhofen a.d.IlmGermany | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3003282622 |
| Daiichi Sankyo Co., Ltd. | IwakiJapan | Analytical testing, Active ingredient (API) manufacture | 3002808054 |
| Daiichi Sankyo Co., Ltd. | KanagawaJapan | Analytical testing, Finished drug manufacture | 3002808070 |
Exclusivity
Patents
52Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| SAVAYSA | EDOXABAN TOSYLATE | Apr 2027 |
| SAVAYSA | EDOXABAN TOSYLATE | Mar 2028 |
| TURALIO | PEXIDARTINIB HYDROCHLORIDE | Nov 2027 |
| TURALIO | PEXIDARTINIB HYDROCHLORIDE | Apr 2028 |
| TURALIO | PEXIDARTINIB HYDROCHLORIDE | May 2033 |
| TURALIO | PEXIDARTINIB HYDROCHLORIDE | Jun 2033 |
| TURALIO | PEXIDARTINIB HYDROCHLORIDE | May 2036 |
| TURALIO | PEXIDARTINIB HYDROCHLORIDE | Jul 2038 |
| VANFLYTA | QUIZARTINIB DIHYDROCHLORIDE | Mar 2027 |
| VANFLYTA | QUIZARTINIB DIHYDROCHLORIDE | Sept 2028 |
| VANFLYTA | QUIZARTINIB DIHYDROCHLORIDE | Aug 2029 |
| VANFLYTA | QUIZARTINIB DIHYDROCHLORIDE | Mar 2030 |
| VANFLYTA | QUIZARTINIB DIHYDROCHLORIDE | May 2030 |
| VANFLYTA | QUIZARTINIB DIHYDROCHLORIDE | Feb 2031 |
| VANFLYTA | QUIZARTINIB DIHYDROCHLORIDE | Sept 2033 |
Catalogue
Marketed products
11Showing 11 of 11.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| DATROWAY | Datopotamab Deruxtecan | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| - | EDOXABAN TOSYLATE | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | EDOXABAN TOSYLATE | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | EDOXABAN TOSYLATE | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| Enhertu | fam-trastuzumab deruxtecan-nxki | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| SAVAYSA | EDOXABAN TOSYLATE | TABLET, FILM COATED | NDA |
| SAVAYSA | EDOXABAN TOSYLATE | TABLET, FILM COATED | NDA |
| SAVAYSA | EDOXABAN TOSYLATE | TABLET, FILM COATED | NDA |
| Turalio | pexidartinib hydrochloride | CAPSULE | NDA |
| VANFLYTA | QUIZARTINIB | TABLET, FILM COATED | NDA |
| VANFLYTA | QUIZARTINIB | TABLET, FILM COATED | NDA |
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.