Register entry
Horizon Pharmaceuticals , Inc.
- Registered sites
- 1
- Drug products
- 12
- Live patents
- 114
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Finished drug manufacture
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Horizon Pharmaceuticals, Inc. | Riviera Beach, FLUnited States | Finished drug manufacture | 3000718824 |
Exclusivity
Patents
114Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| PROCYSBI | CYSTEAMINE BITARTRATE | Jan 2027 |
| PROCYSBI | CYSTEAMINE BITARTRATE | Jul 2027 |
| PROCYSBI | CYSTEAMINE BITARTRATE | Sept 2027 |
| PROCYSBI | CYSTEAMINE BITARTRATE | Mar 2028 |
| PROCYSBI | CYSTEAMINE BITARTRATE | Jun 2034 |
| PROCYSBI | CYSTEAMINE BITARTRATE | Dec 2034 |
| PROCYSBI | CYSTEAMINE BITARTRATE | Aug 2036 |
| PROCYSBI | CYSTEAMINE BITARTRATE | Feb 2037 |
| RAVICTI | GLYCEROL PHENYLBUTYRATE | Sept 2030 |
| RAYOS | PREDNISONE | Aug 2027 |
| RAYOS | PREDNISONE | Jan 2028 |
Catalogue
Marketed products
12Showing 12 of 12.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ACTIMMUNE | Interferon gamma-1b | INJECTION, SOLUTION | BLA |
| BUPHENYL | sodium phenylbutyrate | TABLET | NDA |
| Buphenyl | sodium phenylbutyrate | POWDER | NDA |
| Krystexxa | pegloticase | INJECTION, SOLUTION | BLA |
| Krystexxa | pegloticase | INJECTION, SOLUTION | BLA |
| PROCYSBI | Cysteamine bitartrate | CAPSULE, DELAYED RELEASE PELLETS | NDA |
| PROCYSBI | Cysteamine bitartrate | CAPSULE, DELAYED RELEASE PELLETS | NDA |
| PROCYSBI | Cysteamine bitartrate | GRANULE, DELAYED RELEASE | NDA |
| PROCYSBI | Cysteamine bitartrate | GRANULE, DELAYED RELEASE | NDA |
| Ravicti | glycerol phenylbutyrate | LIQUID | NDA |
| TEPEZZA | teprotumumab | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| UPLIZNA | Inebilizumab | INJECTION | BLA |
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.