Register entry
BEONE MEDICINES USA, INC.
- Registered sites
- 1
- Drug products
- 6
- Live patents
- 29
- Countries
- 1
- Base
- China
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingLabellingFinished drug manufacturePackaging
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| BeOne Pharmaceutical (Suzhou) Co.,Ltd | SuzhouChina | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3014150588 |
Exclusivity
Patents
29Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| BEQALZI | SONROTOCLAX | Apr 2039 |
| BRUKINSA | ZANUBRUTINIB | Apr 2034 |
| BRUKINSA | ZANUBRUTINIB | Aug 2037 |
| BRUKINSA | ZANUBRUTINIB | Jun 2039 |
| BRUKINSA | ZANUBRUTINIB | Jun 2040 |
| BRUKINSA | ZANUBRUTINIB | Jan 2043 |
Catalogue
Marketed products
6Showing 6 of 6.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| BRUKINSA | zanubrutinib | CAPSULE | NDA |
| BRUKINSA | zanubrutinib | TABLET, FILM COATED | NDA |
| Relief Flex | Menthol | PATCH | OTC MONOGRAPH DRUG |
| TEVIMBRA | tislelizumab-jsgr | INJECTION, SOLUTION, CONCENTRATE | BLA |
| TEVIMBRA | tislelizumab-jsgr | INJECTION, SOLUTION, CONCENTRATE | BLA |
| - | zanubrutinib | CAPSULE | 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.