Register entry
Kaleo, Inc.
- Registered sites
- 0
- Drug products
- 4
- Live patents
- 64
- Countries
- 0
- Base
- Unknown
Sites
Facilities
0No registered facilities
This company holds drug listings or approvals but operates no registered establishment of its own, which is normal for an NDA holder that outsources manufacturing.
Exclusivity
Patents
64Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| AUVI-Q | EPINEPHRINE | Dec 2026 |
| AUVI-Q | EPINEPHRINE | Feb 2027 |
| AUVI-Q | EPINEPHRINE | Mar 2028 |
| AUVI-Q | EPINEPHRINE | Nov 2028 |
| AUVI-Q | EPINEPHRINE | Apr 2029 |
| AUVI-Q | EPINEPHRINE | Nov 2029 |
| AUVI-Q | EPINEPHRINE | Dec 2037 |
| EVZIO | NALOXONE HYDROCHLORIDE | Dec 2026 |
| EVZIO | NALOXONE HYDROCHLORIDE | Feb 2027 |
| EVZIO | NALOXONE HYDROCHLORIDE | Feb 2027 |
| EVZIO | NALOXONE HYDROCHLORIDE | May 2027 |
| EVZIO | NALOXONE HYDROCHLORIDE | Mar 2028 |
| EVZIO | NALOXONE HYDROCHLORIDE | Oct 2028 |
| EVZIO | NALOXONE HYDROCHLORIDE | Nov 2028 |
| EVZIO | NALOXONE HYDROCHLORIDE | Apr 2029 |
| EVZIO | NALOXONE HYDROCHLORIDE | Nov 2029 |
| EVZIO | NALOXONE HYDROCHLORIDE | Feb 2031 |
| EVZIO | NALOXONE HYDROCHLORIDE | May 2031 |
| EVZIO | NALOXONE HYDROCHLORIDE | Feb 2032 |
| EVZIO | NALOXONE HYDROCHLORIDE | Jul 2034 |
| EVZIO | NALOXONE HYDROCHLORIDE | Mar 2035 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Dec 2026 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Feb 2027 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Feb 2027 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | May 2027 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Mar 2028 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Oct 2028 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Nov 2028 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Apr 2029 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Nov 2029 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Feb 2031 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | May 2031 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Feb 2032 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Jul 2034 |
| EVZIO (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Mar 2035 |
| NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | Feb 2031 |
| NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | NALOXONE HYDROCHLORIDE | May 2031 |
Catalogue
Marketed products
4Showing 4 of 4.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Auvi-Q | epinephrine | INJECTION, SOLUTION | NDA |
| Auvi-Q | epinephrine | INJECTION, SOLUTION | NDA |
| Auvi-Q | epinephrine | INJECTION, SOLUTION | NDA |
| Naloxone Hydrochloride Injection, USP, Auto-Injector | Naloxone Hydrochloride | INJECTION, SOLUTION | NDA |
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.