Register entry
- Registered sites
- 1
- Active NDC listings
- 25
- Live patents
- 46
- Exclusivities
- 1
- Shortage listings
- 1
- Countries
- 1
- Base
- Italy
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Chiesi Farmaceutici S.p.A.Registrant: Chiesi USA, Inc. | Via San Leonardo 96, Parma, 43122, Italy (ITA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002806655543271642 |
Alert
Drug shortage listings
1| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Deferiprone TabletHematology | Ferriprox, Tablet, 500 mg (NDC 10122-100-10) | To Be Discontinued | - | 7 Nov 20257 Nov 2025 |
Catalogue
Drug listings by form and route
2525 active NDC listings: 25 human prescription drug. By marketing category: NDA 19, BLA 6.
| Dosage form | NDCs |
|---|---|
| capsule | 5 |
| aerosol, metered | 4 |
| injection, powder, lyophilized, for solution | 3 |
| emulsion | 2 |
| injection, solution, concentrate | 2 |
| solution | 2 |
| tablet | 2 |
| capsule, delayed release | 1 |
| gel | 1 |
| injection | 1 |
| suspension | 1 |
| tablet, film coated | 1 |
| Route | NDCs |
|---|---|
| oral | 10 |
| intravenous | 6 |
| respiratory (inhalation) | 5 |
| endotracheal | 1 |
| intramuscular | 1 |
| subcutaneous | 1 |
| topical | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| chiesi usa, inc. | 25 |
Exclusivity
Patents and exclusivities
46| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10758616 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINERnicardipine hydrochloride | product | Apr 2027 |
| 11547758 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINERnicardipine hydrochloride | use | Apr 2027 |
| 7659291 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINERnicardipine hydrochloride | use | Apr 2027 |
| 8455524 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINERnicardipine hydrochloride | use | Apr 2027 |
| 7612102 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINERnicardipine hydrochloride | product | Dec 2027 |
| 9364564 | CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINERnicardipine hydrochloride | product | Dec 2027 |
| 9925265 | KENGREALcangrelor | use | May 2029 |
| 8703156 | FERRIPROXdeferiprone | product | Oct 2029 |
| 9427448 | KENGREALcangrelor | use | Nov 2030 |
| 10010537 | CLEVIPREXclevidipine | product | Oct 2031 |
| 11103490 | CLEVIPREXclevidipine | product | Oct 2031 |
| 8658676 | CLEVIPREXclevidipine | product | Oct 2031 |
| 8680052 | KENGREALcangrelor | use | Mar 2033 |
| 10039780 | KENGREALcangrelor | use | Jul 2035 |
| 9295687 | KENGREALcangrelor | product | Jul 2035 |
| 9439921 | KENGREALcangrelor | product | Jul 2035 |
| 9700575 | KENGREALcangrelor | product | Jul 2035 |
| 10780055 | FERRIPROXdeferiprone | product | Oct 2038 |
| 10940115 | FERRIPROXdeferiprone | product | Oct 2038 |
| 10940116 | FERRIPROXdeferiprone | product | Oct 2038 |
| 11357731 | FERRIPROXdeferiprone | use | Oct 2038 |
| 11458103 | FERRIPROXdeferiprone | product | Oct 2038 |
| 11723874 | FERRIPROXdeferiprone | use | Oct 2038 |
| Product | Exclusivity | Until |
|---|---|---|
| FERRIPROXDEFERIPRONE | ODE-417 Orphan drug | Apr 2028 |
Catalogue
Marketed products
25| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| BETHKIS | tobramycin | solution, respiratory (inhalation) | 10122-820NDA |
| Cleviprex | clevipidine | emulsion, intravenous | 10122-610NDA |
| Cleviprex | clevipidine | emulsion, intravenous | 10122-611NDA |
| Curosurf | poractant alfa | suspension, endotracheal | 10122-510BLA |
| ELFABRIO | pegunigalsidase alfa | injection, solution, concentrate, intravenous | 10122-160BLA |
| ELFABRIO | pegunigalsidase alfa | injection, solution, concentrate, intravenous | 10122-165BLA |
| FERRIPROX | deferiprone | solution, oral | 10122-101NDA |
| FERRIPROX | DEFERIPRONE | tablet, film coated, oral | 10122-103NDA |
| FERRIPROX | deferiprone | tablet, oral | 10122-104NDA |
| FILSUVEZ | birch triterpenes | gel, topical | 10122-310NDA |
| Juxtapid | lomitapide mesylate | capsule, oral | 10122-402NDA |
| Juxtapid | lomitapide mesylate | capsule, oral | 10122-405NDA |
| Juxtapid | lomitapide mesylate | capsule, oral | 10122-410NDA |
| Juxtapid | lomitapide mesylate | capsule, oral | 10122-420NDA |
| Juxtapid | lomitapide mesylate | capsule, oral | 10122-430NDA |
| KENGREAL | cangrelor | injection, powder, lyophilized, for solution, intravenous | 10122-620NDA |
| Lamzede | Velmanase alfa-tycv | injection, powder, lyophilized, for solution, intravenous | 10122-180BLA |
| Myalept | metreleptin | injection, powder, lyophilized, for solution, subcutaneous | 10122-210BLA |
| Mycapssa | Octreotide | capsule, delayed release, oral | 10122-550NDA |
| Revcovi | elapegademase-lvlr | injection, intramuscular | 10122-502BLA |
| Trimbow | beclomethasone dipropionate/formoterol fumarate/glycopyrrolate | aerosol, metered, respiratory (inhalation) | 10122-120NDA |
| Trimbow | beclomethasone dipropionate/formoterol fumarate/glycopyrrolate | aerosol, metered, respiratory (inhalation) | 10122-121NDA |
| Trimbow | beclomethasone dipropionate/formoterol fumarate/glycopyrrolate | aerosol, metered, respiratory (inhalation) | 10122-460NDA |
| Trimbow | beclomethasone dipropionate/formoterol fumarate/glycopyrrolate | aerosol, metered, respiratory (inhalation) | 10122-590NDA |
| ZYFLO | zileuton | tablet, oral | 10122-901NDA |
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Enquiry
Common questions
- Is Chiesi USA, Inc. FDA approved?
- Chiesi USA, Inc. holds 1 FDA-registered establishment in Italy. 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 Chiesi USA, Inc.'s drugs manufactured?
- The FDA register lists Parma. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does Chiesi USA, Inc. make?
- 25 products are listed under Chiesi USA, Inc. in the openFDA NDC Directory, most often as capsule; aerosol, metered; injection, powder, lyophilized, for solution. 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.