Register entry
Astellas Pharma US, Inc.
- Registered sites
- 8
- Drug products
- 40
- Live patents
- 43
- Countries
- 3
- 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
8| Site | Location | Operations | FEI |
|---|---|---|---|
| ASTELLAS IRELAND CO., LIMITED | DUBLINIreland | Analytical testing, Active ingredient (API) manufacture | 3005403283 |
| Astellas Ireland Co., Ltd. | KillorglinIreland | Analytical testing, Finished drug manufacture, Packaging | 3002807020 |
| Astellas Pharma Inc. | TakahagiJapan | Analytical testing, Active ingredient (API) manufacture | 3002808523 |
| Astellas Pharma Inc. | TakaokaJapan | Analytical testing, Finished drug manufacture | 3002807001 |
| Astellas Pharma Inc. | ToyamaJapan | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3002807003 |
| Astellas Pharma Inc. | YaizuJapan | Analytical testing, Finished drug manufacture | 3002809620 |
| Astellas Pharma US Inc. | Northbrook, ILUnited States | Analytical testing | 1000036852 |
| Astellas Gene Therapies, Inc. | Sanford, NCUnited States | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3018803798 |
Exclusivity
Patents
43Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| CRESEMBA | ISAVUCONAZONIUM SULFATE | Sept 2027 |
| CRESEMBA | ISAVUCONAZONIUM SULFATE | Mar 2028 |
| IZERVAY | AVACINCAPTAD PEGOL SODIUM | Nov 2026 |
| IZERVAY | AVACINCAPTAD PEGOL SODIUM | Feb 2027 |
| IZERVAY | AVACINCAPTAD PEGOL SODIUM | Jul 2034 |
| LEXISCAN | REGADENOSON | Feb 2027 |
| VEOZAH | FEZOLINETANT | Apr 2031 |
| VEOZAH | FEZOLINETANT | Mar 2034 |
| VESICARE LS | SOLIFENACIN SUCCINATE | May 2031 |
| XOSPATA | GILTERITINIB FUMARATE | Jul 2030 |
| XOSPATA | GILTERITINIB FUMARATE | Nov 2032 |
| XOSPATA | GILTERITINIB FUMARATE | Jul 2036 |
| XTANDI | ENZALUTAMIDE | Aug 2026 |
| XTANDI | ENZALUTAMIDE | Aug 2027 |
| XTANDI | ENZALUTAMIDE | Sept 2033 |
| XTANDI | ENZALUTAMIDE | Feb 2037 |
Catalogue
Marketed products
40Showing 40 of 40.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ASTAGRAF XL | tacrolimus extended-release capsules | CAPSULE, COATED, EXTENDED RELEASE | NDA |
| ASTAGRAF XL | tacrolimus extended-release capsules | CAPSULE, COATED, EXTENDED RELEASE | NDA |
| ASTAGRAF XL | tacrolimus extended-release capsules | CAPSULE, COATED, EXTENDED RELEASE | NDA |
| CRESEMBA | isavuconazonium sulfate | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| CRESEMBA | isavuconazonium sulfate | CAPSULE | NDA |
| CRESEMBA | isavuconazonium sulfate | CAPSULE | NDA |
| - | Fezolinetant | TABLET, COATED | DRUG FOR FURTHER PROCESSING |
| IZERVAY | avacincaptad pegol | INJECTION | NDA |
| LEXISCAN | regadenoson | INJECTION, SOLUTION | NDA |
| - | Mirabegron | POWDER | BULK INGREDIENT |
| Mycamine | Micafungin sodium | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Myrbetriq | mirabegron | TABLET, FILM COATED, EXTENDED RELEASE | NDA |
| Myrbetriq | mirabegron | TABLET, FILM COATED, EXTENDED RELEASE | NDA |
| Myrbetriq | mirabegron | GRANULE, FOR SUSPENSION, EXTENDED RELEASE | NDA |
| Prograf | Tacrolimus | CAPSULE, GELATIN COATED | NDA |
| Prograf | Tacrolimus | CAPSULE, GELATIN COATED | NDA |
| Prograf | Tacrolimus | CAPSULE, GELATIN COATED | NDA |
| Prograf | Tacrolimus | GRANULE, FOR SUSPENSION | NDA |
| Prograf | Tacrolimus | GRANULE, FOR SUSPENSION | NDA |
| Prograf | Tacrolimus | INJECTION, SOLUTION | NDA |
| - | Tacrolimus | GRANULE, FOR SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | Tacrolimus | GRANULE, FOR SUSPENSION | DRUG FOR FURTHER PROCESSING |
| VEOZAH | fezolinetant | TABLET, FILM COATED | NDA |
| VEOZAH | fezolinetant | TABLET, FILM COATED | NDA |
| VEOZAH | fezolinetant | TABLET, FILM COATED | NDA |
| VESIcare | solifenacin succinate | TABLET, FILM COATED | NDA |
| VESIcare | solifenacin succinate | TABLET, FILM COATED | NDA |
| VYLOY | ZOLBETUXIMAB | INJECTION, POWDER, FOR SUSPENSION | BLA |
| VYLOY | ZOLBETUXIMAB | INJECTION, POWDER, FOR SUSPENSION | BLA |
| Xospata | gilteritinib | TABLET | NDA |
| Xtandi | enzalutamide | CAPSULE | NDA |
| Xtandi | enzalutamide | TABLET | NDA |
| Xtandi | enzalutamide | TABLET | NDA |
| Xtandi | enzalutamide | CAPSULE | NDA |
| Xtandi | enzalutamide | TABLET | NDA |
| - | gilteritinib fumarate | TABLET | DRUG FOR FURTHER PROCESSING |
| - | isavuconazonium sulfate | POWDER | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | mirabegron | POWDER | BULK INGREDIENT |
| - | solifenacin succinate | POWDER | BULK INGREDIENT |
| - | tamsulosin hydrochloride | 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.