epinephrine · Kaleo Inc · NDA 201739
Auvi-Q
Earliest generic entry, as listed · earliest of 3 marketed strengths
2 Nov 2029
Other strengths are listed to 21 Dec 2037.
Blocked by patent: US 8021344.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10688244 | drug product, use U-2980 | 21 Dec 2037 |
| US 10842938 | drug product, use U-2980 | 21 Dec 2037 |
| US 11771830 | drug product, use U-2980 | 21 Dec 2037 |
| US 8021344 | drug product · sets the listed date | 2 Nov 2029 |
| US 8226610 | drug product | 10 Apr 2029 |
| US 8231573 | drug product | 25 Nov 2028 |
| US 7947017 | drug product | 12 Mar 2028 |
| US 8206360 | drug product | 27 Feb 2027 |
| US 11590286 | drug product | 12 Dec 2026 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 201739 · 001 · RLD | solution, intramuscular, subcutaneous | EQ 0.3MG/DELIVERY | 2 Nov 2029 |
| 201739 · 002 · RLD | solution, intramuscular, subcutaneous | EQ 0.15MG/DELIVERY | 21 Dec 2037 |
| 201739 · 003 · RLD | solution, intramuscular, subcutaneous | EQ 0.1MG/DELIVERY | 21 Dec 2037 |