Register entry
- Registered sites
- 1
- Active NDC listings
- 12
- Live patents
- 114
- Countries
- 1
- Base
- United States
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Horizon Pharmaceuticals, Inc.Registrant: Horizon Pharmaceuticals , Inc. | 971 West 15th Street, Riviera Beach, Florida (FL) 33404, United States (USA) | Finished drug manufacture | 3000718824960418825 |
Catalogue
Drug listings by form and route
1212 active NDC listings: 12 human prescription drug. By marketing category: NDA 7, BLA 5.
| Dosage form | NDCs |
|---|---|
| injection, solution | 3 |
| capsule, delayed release pellets | 2 |
| granule, delayed release | 2 |
| injection | 1 |
| injection, powder, lyophilized, for solution | 1 |
| liquid | 1 |
| powder | 1 |
| tablet | 1 |
| Route | NDCs |
|---|---|
| oral | 7 |
| intravenous | 4 |
| subcutaneous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| horizon therapeutics usa, inc. | 12 |
Exclusivity
Patents and exclusivities
114| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9192590 | PROCYSBIcysteamine bitartrate | use | Jan 2027 |
| 9198882 | PROCYSBIcysteamine bitartrate | use | Jan 2027 |
| 9925156 | PROCYSBIcysteamine bitartrate | substance, product | Jan 2027 |
| 9925157 | PROCYSBIcysteamine bitartrate | substance, product | Jan 2027 |
| 9925158 | PROCYSBIcysteamine bitartrate | substance, product | Jan 2027 |
| 9192590*PED | PROCYSBIcysteamine bitartrate | use | Jul 2027 |
| 9198882*PED | PROCYSBIcysteamine bitartrate | use | Jul 2027 |
| 9925156*PED | PROCYSBIcysteamine bitartrate | use | Jul 2027 |
| 9925157*PED | PROCYSBIcysteamine bitartrate | use | Jul 2027 |
| 9925158*PED | PROCYSBIcysteamine bitartrate | use | Jul 2027 |
| 9504699 | RAYOSprednisone | use | Aug 2027 |
| 8026284 | PROCYSBIcysteamine bitartrate | use | Sept 2027 |
| 8168218 | RAYOSprednisone | product | Jan 2028 |
| 8026284*PED | PROCYSBIcysteamine bitartrate | use | Mar 2028 |
| 10045958 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 10045959 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 10183002 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 10183003 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 10183004 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 10183005 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 10183006 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 10668040 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 8642012 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 9254278 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 9326966 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 9561197 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 9962359 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 9999608 | RAVICTIglycerol phenylbutyrate | use | Sept 2030 |
| 9173851 | PROCYSBIcysteamine bitartrate | product | Jun 2034 |
| 9233077 | PROCYSBIcysteamine bitartrate | product | Jun 2034 |
| 9173851*PED | PROCYSBIcysteamine bitartrate | use | Dec 2034 |
| 9233077*PED | PROCYSBIcysteamine bitartrate | use | Dec 2034 |
| 10143665 | PROCYSBIcysteamine bitartrate | use | Aug 2036 |
| 10328037 | PROCYSBIcysteamine bitartrate | use | Aug 2036 |
| 10548859 | PROCYSBIcysteamine bitartrate | use | Aug 2036 |
| 10905662 | PROCYSBIcysteamine bitartrate | use | Aug 2036 |
| 10143665*PED | PROCYSBIcysteamine bitartrate | use | Feb 2037 |
| 10328037*PED | PROCYSBIcysteamine bitartrate | use | Feb 2037 |
| 10548859*PED | PROCYSBIcysteamine bitartrate | use | Feb 2037 |
| 10905662*PED | PROCYSBIcysteamine bitartrate | use | Feb 2037 |
Catalogue
Marketed products
12| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ACTIMMUNE | Interferon gamma-1b | injection, solution, subcutaneous | 75987-111BLA |
| BUPHENYL | sodium phenylbutyrate | tablet, oral | 75987-060NDA |
| Buphenyl | sodium phenylbutyrate | powder, oral | 75987-070NDA |
| Krystexxa | pegloticase | injection, solution, intravenous | 75987-058BLA |
| Krystexxa | pegloticase | injection, solution, intravenous | 75987-080BLA |
| PROCYSBI | Cysteamine bitartrate | capsule, delayed release pellets, oral | 75987-100NDA |
| PROCYSBI | Cysteamine bitartrate | capsule, delayed release pellets, oral | 75987-101NDA |
| PROCYSBI | Cysteamine bitartrate | granule, delayed release, oral | 75987-140NDA |
| PROCYSBI | Cysteamine bitartrate | granule, delayed release, oral | 75987-145NDA |
| Ravicti | glycerol phenylbutyrate | liquid, oral | 75987-050NDA |
| TEPEZZA | teprotumumab | injection, powder, lyophilized, for solution, intravenous | 75987-130BLA |
| UPLIZNA | Inebilizumab | injection, intravenous | 75987-150BLA |
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Enquiry
Common questions
- Is Horizon Pharmaceuticals , Inc. FDA approved?
- Horizon Pharmaceuticals , Inc. holds 1 FDA-registered establishment in the United States. 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 Horizon Pharmaceuticals , Inc.'s drugs manufactured?
- The FDA register lists Riviera Beach, FL. Registered operations: finished drug manufacture.
- What drugs does Horizon Pharmaceuticals , Inc. make?
- 12 products are listed under Horizon Pharmaceuticals , Inc. in the openFDA NDC Directory, most often as injection, solution; capsule, delayed release pellets; granule, delayed release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
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.