Register entry
- Registered sites
- 2
- Active NDC listings
- 0
- Live patents
- 25
- Exclusivities
- 3
- Countries
- 1
- Base
- Japan
Authorisation
Registered operations
Analytical testing2Active ingredient (API) manufacture1Finished drug manufacture1
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Taiho Pharmaceutical Co., Ltd.Registrant: Taiho Oncology, Inc. | 1-1, Iuchi, Takabo, Kitajima-cho, Itano-gun, Tokushima 771-0206, Japan (JPN) | Analytical testing, Finished drug manufacture | 3010872322692199778 |
| Taiho Pharmaceutical Co., Ltd.Registrant: Taiho Oncology, Inc. | 200-22, Motohara, Kamikawa-machi, Kodama-gun, Saitama 367-0241, Japan (JPN) | Analytical testing, Active ingredient (API) manufacture | 3002646390695734327 |
Exclusivity
Patents and exclusivities
25| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8618075 | INQOVIcedazuridine; decitabine | use | Oct 2028 |
| 9567363 | INQOVIcedazuridine; decitabine | substance | Oct 2028 |
| RE46284 | LONSURFtipiracil hydrochloride; trifluridine | use | Sept 2029 |
| 9108973 | LYTGOBIfutibatinib | substance, product | Feb 2033 |
| 8268800 | INQOVIcedazuridine; decitabine | substance | Feb 2034 |
| 10457666 | LONSURFtipiracil hydrochloride; trifluridine | substance, product | Jun 2034 |
| 9527833 | LONSURFtipiracil hydrochloride; trifluridine | substance, product | Jun 2034 |
| 9943537 | LONSURFtipiracil hydrochloride; trifluridine | use | Sept 2034 |
| 10434103 | LYTGOBIfutibatinib | substance, product | Mar 2036 |
| 10456399 | LONSURFtipiracil hydrochloride; trifluridine | use | Feb 2037 |
| 10960004 | LONSURFtipiracil hydrochloride; trifluridine | use | Feb 2037 |
| 11833151 | LYTGOBIfutibatinib | product | Nov 2039 |
| 12195496 | INQOVIcedazuridine; decitabine | product | Oct 2040 |
| 11963971 | INQOVIcedazuridine; decitabine | product | Feb 2041 |
| 12239653 | INQOVIcedazuridine; decitabine | use | Feb 2041 |
| 12697347 | INQOVIcedazuridine; decitabine | use | Dec 2042 |
| Product | Exclusivity | Until |
|---|---|---|
| INQOVICEDAZURIDINE; DECITABINE | I-990 New indication | May 2029 |
| LYTGOBIFUTIBATINIB | ODE* Orphan drug | Sept 2029 |
| LYTGOBIFUTIBATINIB | ODE-410 Orphan drug | Sept 2029 |
Neighbours
Registered in the same town
2- Otsuka America Pharmaceutical, Inc.Itano-gun, JPN
- Bushu Pharmaceuticals, Ltd.Kodama-gun, JPN
Compare
Comparable companies in Japan
- Sumitomo Pharma Co., Ltd.2 sites · 24 NDC
- TAYCA CORPORATION2 sites · 22 NDC
- Hisamitsu Pharmaceutical Co., Inc.2 sites · 16 NDC
- Bushu Pharmaceuticals, Ltd.2 sites · 11 NDC
- ASO Pharmaceutical Co. Ltd.2 sites · 10 NDC
- Lead Chemical Co., Ltd.2 sites · 7 NDC
- SUMITOMO OSAKA CEMENT CO., LTD.2 sites · 6 NDC
- MicroBiopharm Japan Co., Ltd.2 sites · 2 NDC
- Nipro Pharma Corporation2 sites · 2 NDC
- Nissui Corporation2 sites · 2 NDC
Enquiry
Common questions
- Is Taiho Oncology, Inc. FDA approved?
- Taiho Oncology, Inc. holds 2 FDA-registered establishments in Japan. 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 Taiho Oncology, Inc.'s drugs manufactured?
- The FDA register lists Itano-gun; Kodama-gun. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
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.