Register entry

Chiesi USA, Inc.

Registered sites
1
Drug products
25
Live patents
46
Countries
1
Base
Italy
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
SiteLocationOperationsFEI
Chiesi Farmaceutici S.p.A.ParmaItalyAnalytical testing, Labelling, Finished drug manufacture, Packaging3002806655
Exclusivity

Patents

46

Unexpired Orange Book patents where this company is the application holder.

ProductActive ingredientExpiry
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINERNICARDIPINE HYDROCHLORIDEApr 2027
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINERNICARDIPINE HYDROCHLORIDEDec 2027
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINERNICARDIPINE HYDROCHLORIDEApr 2027
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINERNICARDIPINE HYDROCHLORIDEDec 2027
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINERNICARDIPINE HYDROCHLORIDEApr 2027
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINERNICARDIPINE HYDROCHLORIDEDec 2027
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINERNICARDIPINE HYDROCHLORIDEApr 2027
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINERNICARDIPINE HYDROCHLORIDEDec 2027
CLEVIPREXCLEVIDIPINEOct 2031
FERRIPROXDEFERIPRONEOct 2029
FERRIPROXDEFERIPRONEOct 2038
KENGREALCANGRELORMay 2029
KENGREALCANGRELORNov 2030
KENGREALCANGRELORMar 2033
KENGREALCANGRELORJul 2035
Catalogue

Marketed products

25

Showing 25 of 25.

BrandGeneric nameFormCategory
BETHKIStobramycinSOLUTIONNDA
CleviprexclevipidineEMULSIONNDA
CleviprexclevipidineEMULSIONNDA
Curosurfporactant alfaSUSPENSIONBLA
ELFABRIOpegunigalsidase alfaINJECTION, SOLUTION, CONCENTRATEBLA
ELFABRIOpegunigalsidase alfaINJECTION, SOLUTION, CONCENTRATEBLA
FERRIPROXdeferiproneSOLUTIONNDA
FERRIPROXDEFERIPRONETABLET, FILM COATEDNDA
FERRIPROXdeferiproneTABLETNDA
FILSUVEZbirch triterpenesGELNDA
Juxtapidlomitapide mesylateCAPSULENDA
Juxtapidlomitapide mesylateCAPSULENDA
Juxtapidlomitapide mesylateCAPSULENDA
Juxtapidlomitapide mesylateCAPSULENDA
Juxtapidlomitapide mesylateCAPSULENDA
KENGREALcangrelorINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA
LamzedeVelmanase alfa-tycvINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONBLA
MyaleptmetreleptinINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONBLA
MycapssaOctreotideCAPSULE, DELAYED RELEASENDA
Revcovielapegademase-lvlrINJECTIONBLA
Trimbowbeclomethasone dipropionate/formoterol fumarate/glycopyrrolateAEROSOL, METEREDNDA
Trimbowbeclomethasone dipropionate/formoterol fumarate/glycopyrrolateAEROSOL, METEREDNDA
Trimbowbeclomethasone dipropionate/formoterol fumarate/glycopyrrolateAEROSOL, METEREDNDA
Trimbowbeclomethasone dipropionate/formoterol fumarate/glycopyrrolateAEROSOL, METEREDNDA
ZYFLOzileutonTABLETNDA
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.