Register entry
- Registered sites
- 6
- Active NDC listings
- 51
- Labeller names
- 4
- Live patents
- 45
- Exclusivities
- 1
- Countries
- 4
- Base
- United States
Authorisation
Registered operations
Analytical testing6Active ingredient (API) manufacture2Labelling2Finished drug manufacture4Packaging2
Sites
Registered establishments
6| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Eisai Manufacturing LtdRegistrant: Eisai Inc. | Mosquito Way, Hatfield, AL10 9SN, United Kingdom (GBR) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3008356774219516916 |
| Eisai Pharmaceuticals India Private LimitedRegistrant: Eisai Inc. | Plot Nos. 96, 97, 98, 124 &126, Visakha Pharmacity Limited(SEZ), Parawada Mandal, Anakapalli District, Andhra Pradesh 531019, India (IND) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3008394488677318493 |
| Eisai Co., Ltd.Registrant: Eisai Inc. | 1, Kawashimatakehaya-Machi, Kakamigahara, Gifu, 501-6024, Japan (JPN) | Analytical testing, Finished drug manufacture | 3004967045695153247 |
| Eisai Co., Ltd.Registrant: Eisai Inc. | 22, Sunayama, Kamisu-shi, Ibaraki 314-0255, Japan (JPN) | Analytical testing, Active ingredient (API) manufacture | 3002806886695319983 |
| Eisai Inc. | 11675 Crossroads Circle, Baltimore, Maryland (MD) 21220, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 1000158705016758073 |
| Eisai Inc. | 4130 Parklake Ave, Ste 500, Raleigh, North Carolina (NC) 27612, United States (USA) | Analytical testing | 3012653281966861585 |
Catalogue
Drug listings by form and route
5151 active NDC listings: 28 human prescription drug, 21 drug for further processing, 2 bulk ingredient. By marketing category: NDA 24, DRUG FOR FURTHER PROCESSING 21, BLA 4, BULK INGREDIENT 2.
| Dosage form | NDCs |
|---|---|
| tablet | 19 |
| tablet, film coated | 13 |
| capsule | 7 |
| injection, solution | 4 |
| kit | 3 |
| powder | 2 |
| suspension | 2 |
| injection | 1 |
| Route | NDCs |
|---|---|
| oral | 20 |
| intravenous | 3 |
| subcutaneous | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| eisai inc. | 28 |
| eisai co., ltd. | 12 |
| eisai manufacturing ltd | 9 |
| eisai manufacturing ltd. | 2 |
Exclusivity
Patents and exclusivities
45| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8481565 | ARICEPTdonepezil hydrochloride | product | Oct 2026 |
| RE46965 | HALAVENeribulin mesylate | product | Jan 2027 |
| 7612208*PED | LENVIMAlenvatinib mesylate | use | Mar 2027 |
| RE46965*PED | HALAVENeribulin mesylate | use | Jul 2027 |
| 9006256 | LENVIMAlenvatinib mesylate | use | Jul 2027 |
| 9006256*PED | LENVIMAlenvatinib mesylate | use | Jan 2028 |
| 12508313 | LENVIMAlenvatinib mesylate | product | Oct 2030 |
| 12508313*PED | LENVIMAlenvatinib mesylate | use | Apr 2031 |
| 8268848 | DAYVIGOlemborexant | substance, product | Sept 2031 |
| 10259791 | LENVIMAlenvatinib mesylate | substance | Aug 2035 |
| 10407393 | LENVIMAlenvatinib mesylate | substance | Aug 2035 |
| 11186547 | LENVIMAlenvatinib mesylate | substance | Aug 2035 |
| 10188652 | DAYVIGOlemborexant | product | Oct 2035 |
| 10702529 | DAYVIGOlemborexant | product | Oct 2035 |
| 11026944 | DAYVIGOlemborexant | product | Oct 2035 |
| 11090386 | LENVIMAlenvatinib mesylate | use | Feb 2036 |
| 10259791*PED | LENVIMAlenvatinib mesylate | use | Feb 2036 |
| 10407393*PED | LENVIMAlenvatinib mesylate | use | Feb 2036 |
| 11186547*PED | LENVIMAlenvatinib mesylate | use | Feb 2036 |
| 12083112 | LENVIMAlenvatinib mesylate | use | Mar 2036 |
| 11090386*PED | LENVIMAlenvatinib mesylate | use | Aug 2036 |
| 12083112*PED | LENVIMAlenvatinib mesylate | use | Sept 2036 |
| 12226409 | LENVIMAlenvatinib mesylate | use | May 2038 |
| 12226409*PED | LENVIMAlenvatinib mesylate | use | Nov 2038 |
| Product | Exclusivity | Until |
|---|---|---|
| LENVIMALENVATINIB MESYLATE | PED Paediatric | Oct 2027 |
Catalogue
Marketed products
51| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Aricept | donepezil hydrochloride | tablet, film coated, oral | 62856-245NDA |
| Aricept | donepezil hydrochloride | tablet, film coated, oral | 62856-246NDA |
| Aricept | donepezil hydrochloride | tablet, film coated, oral | 62856-247NDA |
| Banzel | rufinamide | tablet, film coated, oral | 62856-582NDA |
| Banzel | rufinamide | tablet, film coated, oral | 62856-583NDA |
| Banzel | rufinamide | suspension, oral | 62856-584NDA |
| DAYVIGO | lemborexant | tablet, film coated, oral | 62856-405NDA |
| DAYVIGO | lemborexant | tablet, film coated, oral | 62856-410NDA |
| Fycompa | perampanel | tablet, oral | 62856-272NDA |
| Fycompa | perampanel | tablet, oral | 62856-274NDA |
| Fycompa | perampanel | tablet, oral | 62856-276NDA |
| Fycompa | perampanel | tablet, oral | 62856-278NDA |
| Fycompa | perampanel | tablet, oral | 62856-280NDA |
| Fycompa | perampanel | tablet, oral | 62856-282NDA |
| Fycompa | perampanel | suspension, oral | 62856-290NDA |
| Halaven | eribulin mesylate | injection, intravenous | 62856-389NDA |
| LECANEMAB AUTOINJECTOR | lecanemab-irmb | injection, solution, subcutaneous | 62856-220BLA |
| LECANEMAB AUTOINJECTOR | lecanemab-irmb | injection, solution, subcutaneous | 62856-222BLA |
| LEQEMBI | lecanemab | injection, solution, intravenous | 62856-212BLA |
| LEQEMBI | lecanemab | injection, solution, intravenous | 62856-215BLA |
| - | LORCASERIN HYDROCHLORIDE HEMIHYDRATE, LORCASERIN | tablet | 11071-931DRUG FOR FURTHER PROCESSING |
| Lenvima | Lenvatinib | capsule, oral | 62856-704NDA |
| Lenvima | Lenvatinib | capsule, oral | 62856-708NDA |
| Lenvima | Lenvatinib | capsule, oral | 62856-710NDA |
| Lenvima | Lenvatinib | capsule, oral | 62856-712NDA |
| Lenvima | Lenvatinib | kit | 62856-714NDA |
| Lenvima | Lenvatinib | kit | 62856-718NDA |
| Lenvima | Lenvatinib | capsule, oral | 62856-720NDA |
| Lenvima | Lenvatinib | kit | 62856-724NDA |
| - | avatrombopag maleate | tablet, film coated | 60510-612DRUG FOR FURTHER PROCESSING |
| - | donepezil hydrochloride | tablet, film coated | 11071-871DRUG FOR FURTHER PROCESSING |
| - | donepezil hydrochloride | tablet, film coated | 60510-613DRUG FOR FURTHER PROCESSING |
| - | donepezil hydrochloride | tablet, film coated | 60510-614DRUG FOR FURTHER PROCESSING |
| - | eribulin mesylate | powder | 11071-891BULK INGREDIENT |
| - | eribulin mesylate | powder | 11071-892BULK INGREDIENT |
| - | lemborexant | tablet, film coated | 60510-405DRUG FOR FURTHER PROCESSING |
| - | lemborexant | tablet, film coated | 60510-410DRUG FOR FURTHER PROCESSING |
| - | lenvatinib | capsule | 11071-912DRUG FOR FURTHER PROCESSING |
| - | lenvatinib | capsule | 11071-913DRUG FOR FURTHER PROCESSING |
| - | perampanel | tablet | 11071-902DRUG FOR FURTHER PROCESSING |
| - | perampanel | tablet | 11071-903DRUG FOR FURTHER PROCESSING |
| - | perampanel | tablet | 11071-904DRUG FOR FURTHER PROCESSING |
| - | perampanel | tablet | 11071-905DRUG FOR FURTHER PROCESSING |
| - | perampanel | tablet | 11071-906DRUG FOR FURTHER PROCESSING |
| - | perampanel | tablet | 11071-907DRUG FOR FURTHER PROCESSING |
| - | perampanel | tablet | 60510-604DRUG FOR FURTHER PROCESSING |
| - | perampanel | tablet | 60510-605DRUG FOR FURTHER PROCESSING |
| - | perampanel | tablet | 60510-606DRUG FOR FURTHER PROCESSING |
| - | perampanel | tablet | 60510-607DRUG FOR FURTHER PROCESSING |
| - | perampanel | tablet | 60510-608DRUG FOR FURTHER PROCESSING |
| - | perampanel | tablet | 60510-609DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
12- Hetero Labs LimitedAnakapalli District, IND · 2 sites
- Catalent Pharma Solutions Inc.Baltimore, MD
- Lupin LimitedAnakapalli District, IND
- Ajinomoto Health & Nutrition North America, Inc.Raleigh, NC
- SOLARA ACTIVE PHARMA SCIENCES LIMITEDAnakapalli District, IND
- TransOx, Inc.Baltimore, MD
- SpecGx LLCRaleigh, NC
- Syngene International LimitedBaltimore, MD
- GLAND PHARMA LIMITEDAnakapalli District, IND
- Hetero Drugs LimitedAnakapalli district, IND
- Honour Lab LimitedAnakapalli District, IND
- Aragen Life Sciences LimitedAnakapalli District, IND
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Enquiry
Common questions
- Is Eisai Inc. FDA approved?
- Eisai Inc. holds 6 FDA-registered establishments across 4 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 Eisai Inc.'s drugs manufactured?
- At registered sites in the United Kingdom, India, Japan, the United States. The FDA register lists Hatfield; Anakapalli District; Gifu; Kamisu-shi; Baltimore, MD; Raleigh, NC. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Eisai Inc. make?
- 51 products are listed under Eisai Inc. in the openFDA NDC Directory, most often as tablet; tablet, film coated; 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.