Register entry
Sumitomo Pharma Co., Ltd.
- Registered sites
- 2
- Drug products
- 24
- Live patents
- 112
- 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) manufactureLabellingFinished drug manufacturePackaging
Sites
Facilities
2| Site | Location | Operations | FEI |
|---|---|---|---|
| Sumitomo Pharma Co., Ltd. | OitaJapan | Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3005619533 |
| Sumitomo Pharma Co., Ltd. | SuzukaJapan | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3003028650 |
Exclusivity
Patents
112Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| APTIOM | ESLICARBAZEPINE ACETATE | Sept 2028 |
| APTIOM | ESLICARBAZEPINE ACETATE | Oct 2028 |
| APTIOM | ESLICARBAZEPINE ACETATE | Apr 2030 |
| APTIOM | ESLICARBAZEPINE ACETATE | Aug 2032 |
| GEMTESA | VIBEGRON | Apr 2029 |
| GEMTESA | VIBEGRON | Mar 2034 |
| GEMTESA | VIBEGRON | Dec 2034 |
| GEMTESA | VIBEGRON | Mar 2040 |
| GEMTESA | VIBEGRON | Jul 2042 |
| KYNMOBI | APOMORPHINE HYDROCHLORIDE | Aug 2029 |
| KYNMOBI | APOMORPHINE HYDROCHLORIDE | Jun 2030 |
| KYNMOBI | APOMORPHINE HYDROCHLORIDE | Dec 2031 |
| KYNMOBI | APOMORPHINE HYDROCHLORIDE | Apr 2036 |
| LONHALA MAGNAIR KIT | GLYCOPYRROLATE | Dec 2028 |
| LONHALA MAGNAIR KIT | GLYCOPYRROLATE | Feb 2029 |
| LONHALA MAGNAIR KIT | GLYCOPYRROLATE | Oct 2030 |
| LONHALA MAGNAIR KIT | GLYCOPYRROLATE | Sept 2032 |
| LONHALA MAGNAIR KIT | GLYCOPYRROLATE | May 2033 |
| LONHALA MAGNAIR KIT | GLYCOPYRROLATE | Sept 2035 |
| LONHALA MAGNAIR KIT | GLYCOPYRROLATE | Nov 2036 |
| LONHALA MAGNAIR KIT | GLYCOPYRROLATE | Dec 2036 |
| MYFEMBREE | ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX | Jan 2029 |
| MYFEMBREE | ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX | Sept 2033 |
| MYFEMBREE | ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX | Sept 2037 |
| MYFEMBREE | ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX | May 2038 |
| MYFEMBREE | ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX | Nov 2042 |
| ORGOVYX | RELUGOLIX | Jan 2029 |
| ORGOVYX | RELUGOLIX | Sept 2033 |
| ORGOVYX | RELUGOLIX | Feb 2036 |
| ORGOVYX | RELUGOLIX | Sept 2037 |
Catalogue
Marketed products
24Showing 24 of 24.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Aptiom | ESLICARBAZEPINE ACETATE | TABLET | NDA |
| Aptiom | ESLICARBAZEPINE ACETATE | TABLET | NDA |
| Aptiom | ESLICARBAZEPINE ACETATE | TABLET | NDA |
| Aptiom | ESLICARBAZEPINE ACETATE | TABLET | NDA |
| Aptiom | ESLICARBAZEPINE ACETATE | KIT | NDA |
| - | Droxidopa | POWDER | DRUG FOR FURTHER PROCESSING |
| GEMTESA | vibegron | TABLET, FILM COATED | NDA |
| Latuda | lurasidone hydrochloride | TABLET, FILM COATED | NDA |
| Latuda | lurasidone hydrochloride | TABLET, FILM COATED | NDA |
| Latuda | lurasidone hydrochloride | TABLET, FILM COATED | NDA |
| Latuda | lurasidone hydrochloride | TABLET, FILM COATED | NDA |
| Latuda | lurasidone hydrochloride | TABLET, FILM COATED | NDA |
| - | Lurasidone hydrochloride | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | MEROPENEM | POWDER | BULK INGREDIENT |
| - | Meropenem | POWDER | DRUG FOR FURTHER PROCESSING |
| Myfembree | relugolix, estradiol hemihydrate, and norethindrone acetate | TABLET, FILM COATED | NDA |
| Orgovyx | relugolix | TABLET, FILM COATED | NDA |
| RETHYMIC | allogenic thymocyte-depleted thymus tissue-agdc | IMPLANT | BLA |
| - | Zonisamide | POWDER | BULK INGREDIENT |
| - | lurasidone hydrochloride | POWDER | BULK INGREDIENT |
| - | lurasidone hydrochloride | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | lurasidone hydrochloride | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | lurasidone hydrochloride | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | lurasidone hydrochloride | TABLET, FILM COATED | 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.