Register entry
BioMarin International Limited
- Registered sites
- 2
- Drug products
- 19
- Live patents
- 28
- Countries
- 2
- Base
- United States
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 |
|---|---|---|---|
| BioMarin International Limited | ShanballyIreland | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3010085632 |
| BioMarin Pharmaceutical Inc. | Novato, CAUnited States | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture | 3004079983 |
Exclusivity
Patents
28Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| KUVAN | SAPROPTERIN DIHYDROCHLORIDE | Nov 2032 |
| KUVAN | SAPROPTERIN DIHYDROCHLORIDE | May 2033 |
| VOXZOGO | VOSORITIDE | May 2030 |
| VOXZOGO | VOSORITIDE | Jun 2035 |
| VOXZOGO | VOSORITIDE | Aug 2036 |
| VOXZOGO | VOSORITIDE | Jul 2042 |
Catalogue
Marketed products
19Showing 19 of 19.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Brineura | cerliponase alfa | KIT | BLA |
| Kuvan | SAPROPTERIN DIHYDROCHLORIDE | TABLET | NDA |
| Kuvan | SAPROPTERIN DIHYDROCHLORIDE | POWDER, FOR SOLUTION | NDA |
| Kuvan | sapropterin dihydrochloride | POWDER, FOR SOLUTION | NDA |
| NAGLAZYME | galsulfase | SOLUTION | BLA |
| Palynziq | pegvaliase-pqpz | INJECTION, SOLUTION | BLA |
| Palynziq | pegvaliase-pqpz | INJECTION, SOLUTION | BLA |
| Palynziq | pegvaliase-pqpz | INJECTION, SOLUTION | BLA |
| - | VOSORITIDE | INJECTION, SOLUTION, CONCENTRATE | DRUG FOR FURTHER PROCESSING |
| VOXZOGO 0.4mg | vosoritide | KIT | NDA |
| VOXZOGO 0.56mg | vosoritide | KIT | NDA |
| VOXZOGO 1.2mg | vosoritide | KIT | NDA |
| - | cerliponase alfa | INJECTION, SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | cerliponase alfa | INJECTION, SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | elosulfase alfa | INJECTION, SOLUTION, CONCENTRATE | DRUG FOR FURTHER PROCESSING |
| - | elosulfase alfa | INJECTION, SOLUTION, CONCENTRATE | DRUG FOR FURTHER PROCESSING |
| - | laronidase | INJECTION, SOLUTION, CONCENTRATE | DRUG FOR FURTHER PROCESSING |
| - | pegvaliase-pqpz | INJECTION, SOLUTION | DRUG FOR FURTHER PROCESSING |
| - | pegvaliase-pqpz | INJECTION, SOLUTION | 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.