Register entry
Recordati Rare Diseases
- Registered sites
- 1
- Drug products
- 21
- Live patents
- 37
- Countries
- 1
- Base
- France
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 |
|---|---|---|---|
| Recordati Rare Diseases | PuteauxFrance | Finished drug manufacture | 3008341412 |
Exclusivity
Patents
37Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ISTURISA | OSILODROSTAT PHOSPHATE | Aug 2026 |
| ISTURISA | OSILODROSTAT PHOSPHATE | Mar 2029 |
| ISTURISA | OSILODROSTAT PHOSPHATE | Jan 2031 |
| ISTURISA | OSILODROSTAT PHOSPHATE | May 2033 |
| ISTURISA | OSILODROSTAT PHOSPHATE | Jul 2035 |
| ISTURISA | OSILODROSTAT PHOSPHATE | Oct 2035 |
| NEOPROFEN | IBUPROFEN LYSINE | Mar 2032 |
| SIGNIFOR | PASIREOTIDE DIASPARTATE | Dec 2026 |
| SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | Oct 2026 |
| SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | Dec 2026 |
| SIGNIFOR LAR KIT | PASIREOTIDE PAMOATE | May 2028 |
Catalogue
Marketed products
21Showing 21 of 21.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| CYSTADROPS | cysteamine hydrochloride | SOLUTION | NDA |
| Carbaglu | Carglumic Acid | TABLET, FOR SUSPENSION | NDA |
| Chemet | succimer | CAPSULE | NDA |
| Cystadane | betaine | POWDER, FOR SOLUTION | NDA |
| Enjaymo | sutimlimab-jome | INJECTION, SOLUTION, CONCENTRATE | BLA |
| Isturisa | osilodrostat | TABLET, COATED | NDA |
| Isturisa | OSILODROSTAT | TABLET, COATED | NDA |
| Isturisa | Osilodrostat | TABLET, COATED | NDA |
| Isturisa | Osilodrostat | TABLET, COATED | NDA |
| NEOPROFEN | ibuprofen lysine | SOLUTION | NDA |
| Panhematin | hemin | POWDER, FOR SOLUTION | BLA |
| Signifor | pasireotide | INJECTION | NDA |
| Signifor | pasireotide | INJECTION | NDA |
| Signifor | pasireotide | INJECTION | NDA |
| Signifor LAR | pasireotide | KIT | NDA |
| Signifor LAR | pasireotide | KIT | NDA |
| Signifor LAR | pasireotide | KIT | NDA |
| Signifor LAR | pasireotide | KIT | NDA |
| Signifor LAR | pasireotide | KIT | NDA |
| Sylvant | Siltuximab | INJECTION, POWDER, FOR SOLUTION | BLA |
| Sylvant | Siltuximab | INJECTION, POWDER, FOR SOLUTION | 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.