Register entry
- Registered sites
- 8
- Active NDC listings
- 37
- Labeller names
- 3
- Live patents
- 40
- Exclusivities
- 3
- Countries
- 3
- Base
- Japan
Authorisation
Registered operations
Analytical testing8Active ingredient (API) manufacture4Finished drug manufacture5Packaging1
Sites
Registered establishments
8| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| ASTELLAS IRELAND CO., LIMITEDRegistrant: Astellas Pharma US, Inc. | DAMASTOWN ROAD, DUBLIN, D15 K851, Ireland (IRL) | Analytical testing, Active ingredient (API) manufacture | 3005403283986209328 |
| Astellas Ireland Co., Ltd.Registrant: Astellas Pharma US, Inc. | Bansha, Killorglin, Co Kerry V93FC86, Ireland (IRL) | Analytical testing, Finished drug manufacture, Packaging | 3002807020985098269 |
| Astellas Pharma Inc.Registrant: Astellas Pharma US, Inc. | 160-2, Akahama, Takahagi, Ibaraki 318-0004, Japan (JPN) | Analytical testing, Active ingredient (API) manufacture | 3002808523695087171 |
| Astellas Pharma Inc.Registrant: Astellas Pharma US, Inc. | 30 Toidesakaemachi, Takaoka, Toyama 939-1118, Japan (JPN) | Analytical testing, Finished drug manufacture | 3002807001695534669 |
| Astellas Pharma Inc.Registrant: Astellas Pharma US, Inc. | 2-178, Kojinmachi, Toyama, Toyama 930-0809, Japan (JPN) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3002807003695745612 |
| Astellas Pharma Inc.Registrant: Astellas Pharma US, Inc. | 180, Ozumi, Yaizu, Shizuoka 425-0072, Japan (JPN) | Analytical testing, Finished drug manufacture | 3002809620695086702 |
| Astellas Pharma US Inc.Registrant: Astellas Pharma US, Inc. | 2375 Waterview Drive, Northbrook, Illinois (IL) 60062, United States (USA) | Analytical testing | 1000036852605764828 |
| Astellas Gene Therapies, Inc.Registrant: Astellas Pharma US, Inc. | 6074 Enterprise Park Dr, Sanford, North Carolina (NC) 27330-9709, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3018803798118845780 |
Catalogue
Drug listings by form and route
3737 active NDC listings: 28 human prescription drug, 5 bulk ingredient, 4 drug for further processing. By marketing category: NDA 26, BULK INGREDIENT 4, DRUG FOR FURTHER PROCESSING 4, BLA 2, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 1.
| Dosage form | NDCs |
|---|---|
| powder | 5 |
| tablet | 5 |
| capsule | 4 |
| granule, for suspension | 4 |
| capsule, coated, extended release | 3 |
| capsule, gelatin coated | 3 |
| tablet, film coated | 3 |
| injection, powder, for suspension | 2 |
| injection, solution | 2 |
| tablet, film coated, extended release | 2 |
| granule, for suspension, extended release | 1 |
| injection | 1 |
| injection, powder, lyophilized, for solution | 1 |
| tablet, coated | 1 |
| Route | NDCs |
|---|---|
| oral | 22 |
| intravenous | 5 |
| intravitreal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| astellas pharma us, inc. | 30 |
| astellas pharma inc. | 5 |
| astellas ireland co., limited | 2 |
Exclusivity
Patents and exclusivities
40| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8236773 | IZERVAYavacincaptad pegol sodium | use | Nov 2026 |
| 8106183 | LEXISCANregadenoson | substance | Feb 2027 |
| RE47301 | LEXISCANregadenoson | product | Feb 2027 |
| 7579456 | IZERVAYavacincaptad pegol sodium | substance | Feb 2027 |
| 9617546 | IZERVAYavacincaptad pegol sodium | substance | Feb 2027 |
| 7709517 | XTANDIenzalutamide | substance, product | Aug 2027 |
| 10206879 | CRESEMBAisavuconazonium sulfate | product | Sept 2027 |
| 10603280 | CRESEMBAisavuconazonium sulfate | product | Sept 2027 |
| 10206879*PED | CRESEMBAisavuconazonium sulfate | use | Mar 2028 |
| 10603280*PED | CRESEMBAisavuconazonium sulfate | use | Mar 2028 |
| 9487491 | XOSPATAgilteritinib fumarate | use | Jul 2030 |
| 8871761 | VEOZAHfezolinetant | substance | Apr 2031 |
| 9918970 | VESICARE LSsolifenacin succinate | product | May 2031 |
| 8969336 | XOSPATAgilteritinib fumarate | substance, product | Nov 2032 |
| 11839689 | XTANDIenzalutamide | product | Sept 2033 |
| 12447128 | XTANDIenzalutamide | use | Sept 2033 |
| 12502357 | XTANDIenzalutamide | use | Sept 2033 |
| 10836768 | VEOZAHfezolinetant | use | Mar 2034 |
| 9422299 | VEOZAHfezolinetant | substance, product | Mar 2034 |
| 9987274 | VEOZAHfezolinetant | use | Mar 2034 |
| 11273171 | IZERVAYavacincaptad pegol sodium | use | Jul 2034 |
| 11491176 | IZERVAYavacincaptad pegol sodium | use | Jul 2034 |
| 12016875 | IZERVAYavacincaptad pegol sodium | use | Jul 2034 |
| 10786500 | XOSPATAgilteritinib fumarate | product | Jul 2036 |
| 11938130 | XOSPATAgilteritinib fumarate | product | Jul 2036 |
| 11938131 | XOSPATAgilteritinib fumarate | product | Jul 2036 |
| 11938132 | XOSPATAgilteritinib fumarate | product | Jul 2036 |
| 11938133 | XOSPATAgilteritinib fumarate | product | Jul 2036 |
| 11944620 | XOSPATAgilteritinib fumarate | product | Jul 2036 |
| 12161628 | XTANDIenzalutamide | use | Feb 2037 |
| Product | Exclusivity | Until |
|---|---|---|
| CRESEMBAISAVUCONAZONIUM SULFATE | PED Paediatric | Jun 2031 |
| VEOZAHFEZOLINETANT | NCE New chemical entity | May 2028 |
| XTANDIENZALUTAMIDE | I-926 New indication | Nov 2026 |
Catalogue
Marketed products
40Showing 37 of 40.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ASTAGRAF XL | tacrolimus extended-release capsules | capsule, coated, extended release, oral | 0469-0647NDA |
| ASTAGRAF XL | tacrolimus extended-release capsules | capsule, coated, extended release, oral | 0469-0677NDA |
| ASTAGRAF XL | tacrolimus extended-release capsules | capsule, coated, extended release, oral | 0469-0687NDA |
| CRESEMBA | isavuconazonium sulfate | injection, powder, lyophilized, for solution, intravenous | 0469-0420NDA |
| CRESEMBA | isavuconazonium sulfate | capsule, oral | 0469-0520NDA |
| CRESEMBA | isavuconazonium sulfate | capsule, oral | 0469-2860NDA |
| - | Fezolinetant | tablet, coated | 12838-3360DRUG FOR FURTHER PROCESSING |
| IZERVAY | avacincaptad pegol | injection, intravitreal | 82829-002NDA |
| LEXISCAN | regadenoson | injection, solution, intravenous | 0469-6501NDA |
| - | Mirabegron | powder | 57438-2603BULK INGREDIENT |
| Myrbetriq | mirabegron | tablet, film coated, extended release, oral | 0469-2601NDA |
| Myrbetriq | mirabegron | tablet, film coated, extended release, oral | 0469-2602NDA |
| Myrbetriq | mirabegron | granule, for suspension, extended release, oral | 0469-5020NDA |
| Prograf | Tacrolimus | capsule, gelatin coated, oral | 0469-0607NDA |
| Prograf | Tacrolimus | capsule, gelatin coated, oral | 0469-0617NDA |
| Prograf | Tacrolimus | capsule, gelatin coated, oral | 0469-0657NDA |
| Prograf | Tacrolimus | granule, for suspension, oral | 0469-1230NDA |
| Prograf | Tacrolimus | granule, for suspension, oral | 0469-1330NDA |
| Prograf | Tacrolimus | injection, solution, intravenous | 0469-3016NDA |
| - | Tacrolimus | granule, for suspension | 12838-1230DRUG FOR FURTHER PROCESSING |
| - | Tacrolimus | granule, for suspension | 12838-1330DRUG FOR FURTHER PROCESSING |
| VEOZAH | fezolinetant | tablet, film coated, oral | 0469-2460NDA |
| VEOZAH | fezolinetant | tablet, film coated, oral | 0469-2660NDA |
| VEOZAH | fezolinetant | tablet, film coated, oral | 0469-2760NDA |
| VYLOY | ZOLBETUXIMAB | injection, powder, for suspension, intravenous | 0469-3425BLA |
| VYLOY | ZOLBETUXIMAB | injection, powder, for suspension, intravenous | 0469-4425BLA |
| Xospata | gilteritinib | tablet, oral | 0469-1425NDA |
| Xtandi | enzalutamide | capsule, oral | 0469-0125NDA |
| Xtandi | enzalutamide | tablet, oral | 0469-0625NDA |
| Xtandi | enzalutamide | tablet, oral | 0469-0725NDA |
| Xtandi | enzalutamide | capsule, oral | 0469-1125NDA |
| Xtandi | enzalutamide | tablet, oral | 0469-1725NDA |
| - | gilteritinib fumarate | tablet | 12838-1425DRUG FOR FURTHER PROCESSING |
| - | isavuconazonium sulfate | powder | 0469-1020BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | mirabegron | powder | 0469-2603BULK INGREDIENT |
| - | solifenacin succinate | powder | 57438-8096BULK INGREDIENT |
| - | tamsulosin hydrochloride | powder | 12838-2788BULK INGREDIENT |
Neighbours
Registered in the same town
12- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.Dublin, IRL; Sanford, NC · 2 sites
- Allergan, Inc.Dublin, IRL
- Takeda Pharmaceuticals U.S.A., Inc.Dublin, IRL
- West Pharmaceutical Services, Inc.Dublin, IRL
- Alexion Pharmaceuticals, Inc.Dublin, IRL
- COTY LANCASTER SAMSANFORD, NC
- LEO Pharma A/SDublin, IRL
- KATAYAMA SEIYAKUSYO CO., LTD.TOYAMA, JPN
- LIEBEL-FLARSHEIM COMPANY LLC.Dublin, IRL
- Lead Chemical Co., Ltd.Toyama, JPN
- Clarochem Ireland LimitedDublin, IRL
- Fukuzyu Pharmaceutical Co., Ltd.Toyama, JPN
Compare
Comparable companies in Japan
- Ajinomoto Health & Nutrition North America, Inc.9 sites · 20 NDC
- Otsuka America Pharmaceutical, Inc.6 sites · 62 NDC
- Shionogi Pharma Co., Ltd.4 sites · 17 NDC
- Terumo Pharmaceutical Services GmbH4 sites · 12 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 Astellas Pharma US, Inc. FDA approved?
- Astellas Pharma US, Inc. holds 8 FDA-registered establishments across 3 countries. 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 Astellas Pharma US, Inc.'s drugs manufactured?
- At registered sites in Ireland, Japan, the United States. The FDA register lists DUBLIN; Killorglin; Takahagi; Takaoka; Toyama; Yaizu, and 2 more. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging.
- What drugs does Astellas Pharma US, Inc. make?
- 40 products are listed under Astellas Pharma US, Inc. in the openFDA NDC Directory, most often as powder; tablet; capsule. 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.