Register entry
- Registered sites
- 0
- Active NDC listings
- 4
- Labeller names
- 2
- Live patents
- 64
- Countries
- 0
Catalogue
Drug listings by form and route
44 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.
| Dosage form | NDCs |
|---|---|
| injection, solution | 4 |
| Route | NDCs |
|---|---|
| intramuscular | 4 |
| subcutaneous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| kaleo, inc | 3 |
| kaleo, inc. | 1 |
Exclusivity
Patents and exclusivities
64| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 11590286 | AUVI-Q, EVZIO, EVZIO (AUTOINJECTOR)epinephrine; naloxone hydrochloride | product | Dec 2026 |
| 9238108 | EVZIO, EVZIO (AUTOINJECTOR)naloxone hydrochloride | product | Feb 2027 |
| 8206360 | AUVI-Q, EVZIO, EVZIO (AUTOINJECTOR)epinephrine; naloxone hydrochloride | product | Feb 2027 |
| 9724471 | EVZIO, EVZIO (AUTOINJECTOR)naloxone hydrochloride | product | May 2027 |
| 7947017 | AUVI-Q, EVZIO, EVZIO (AUTOINJECTOR)epinephrine; naloxone hydrochloride | product | Mar 2028 |
| 7749194 | EVZIO, EVZIO (AUTOINJECTOR)naloxone hydrochloride | product | Oct 2028 |
| 8231573 | AUVI-Q, EVZIO, EVZIO (AUTOINJECTOR)epinephrine; naloxone hydrochloride | product | Nov 2028 |
| 8226610 | AUVI-Q, EVZIO, EVZIO (AUTOINJECTOR)epinephrine; naloxone hydrochloride | product | Apr 2029 |
| 8021344 | AUVI-Q, EVZIO, EVZIO (AUTOINJECTOR)epinephrine; naloxone hydrochloride | product | Nov 2029 |
| 10322239 | EVZIO, EVZIO (AUTOINJECTOR), NALOXONE HYDROCHLORIDE (AUTOINJECTOR)naloxone hydrochloride | use | Feb 2031 |
| 8939943 | EVZIO, EVZIO (AUTOINJECTOR), NALOXONE HYDROCHLORIDE (AUTOINJECTOR)naloxone hydrochloride | product | Feb 2031 |
| 9022022 | EVZIO, EVZIO (AUTOINJECTOR), NALOXONE HYDROCHLORIDE (AUTOINJECTOR)naloxone hydrochloride | product | Feb 2031 |
| 9474869 | EVZIO, EVZIO (AUTOINJECTOR), NALOXONE HYDROCHLORIDE (AUTOINJECTOR)naloxone hydrochloride | product | Feb 2031 |
| 9814838 | NALOXONE HYDROCHLORIDE (AUTOINJECTOR)naloxone hydrochloride | product | Feb 2031 |
| 10143792 | EVZIO (AUTOINJECTOR), NALOXONE HYDROCHLORIDE (AUTOINJECTOR)naloxone hydrochloride | use | May 2031 |
| 10143972 | EVZIOnaloxone hydrochloride | use | May 2031 |
| 8627816 | EVZIO, EVZIO (AUTOINJECTOR)naloxone hydrochloride | product | Feb 2032 |
| 9517307 | EVZIO, EVZIO (AUTOINJECTOR)naloxone hydrochloride | product | Jul 2034 |
| 10220158 | EVZIO, EVZIO (AUTOINJECTOR)naloxone hydrochloride | product | Mar 2035 |
| 10688244 | AUVI-Qepinephrine | product | Dec 2037 |
| 10842938 | AUVI-Qepinephrine | product | Dec 2037 |
| 11771830 | AUVI-Qepinephrine | product | Dec 2037 |
Catalogue
Marketed products
4| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Auvi-Q | epinephrine | injection, solution, intramuscular | 60842-021NDA |
| Auvi-Q | epinephrine | injection, solution, intramuscular | 60842-022NDA |
| Auvi-Q | epinephrine | injection, solution, intramuscular | 60842-023NDA |
| Naloxone Hydrochloride Injection, USP, Auto-Injector | Naloxone Hydrochloride | injection, solution, intramuscular, subcutaneous | 60842-002NDA |
Compare
Other companies listing epinephrine
- Viatris Inc.18 sites · 135 NDC
- Baxter Healthcare Corporation16 sites · 416 NDC
- Amneal Pharmaceuticals of New York, LLC14 sites · 227 NDC
- Glenmark Pharmaceuticals Inc., USA9 sites · 383 NDC
- Hospira, Inc.7 sites · 332 NDC
- Par Health USA, LLC5 sites · 211 NDC
- American Regent, Inc.5 sites · 70 NDC
- GLAND PHARMA LIMITED4 sites · 263 NDC
- International Medication Systems, Ltd.3 sites · 2,801 NDC
- ProPharma Distribution, LLC.3 sites · 100 NDC
Enquiry
Common questions
- Is Kaleo, Inc. FDA approved?
- Kaleo, Inc. holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Kaleo, Inc. make?
- 4 products are listed under Kaleo, Inc. in the openFDA NDC Directory, most often as injection, 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.