epinephrine · Bpi Labs · NDA 205029, 209359, 211363, 215425, 220626
Epinephrine
Earliest generic entry, as listed · earliest of 8 marketed strengths
17 Jan 2045
7 of 8 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 12539283.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12539283 | drug product · sets the listed date | 17 Jan 2045 |
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 · 10
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205029 · 001 · RLD | solution, intravenous, intraocular, intramuscular, subcutaneous | 1MG/ML (1MG/ML) | open |
| 205029 · 002 · RLD | solution, intramuscular, intravenous, subcutaneous | 10MG/10ML (1MG/ML) | open |
| 205029 · 003 · RLD · discontinued | solution, intravenous | 1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 205029 · 004 · RLD | solution, intramuscular, intravenous, subcutaneous | 30MG/30ML (1MG/ML) | open |
| 205029 · 005 · RLD | solution, intramuscular, intravenous, subcutaneous | 1MG/ML (1MG/ML) | open |
| 209359 · 001 · RLD · discontinued | solution, intravenous | 1MG/10ML (0.1MG/ML) | open |
| 211363 · 001 · RLD | solution, intravenous | 1MG/10ML (0.1MG/ML) | open |
| 215425 · 001 · RLD | solution, intramuscular, intravenous, subcutaneous | 30MG/30ML (1MG/ML) | 17 Jan 2045 |
| 220626 · 001 · RLD | solution, intramuscular, intravenous, subcutaneous | 1MG/ML (1MG/ML) | open |
| 220626 · 002 · RLD | solution, intramuscular, intravenous, subcutaneous | 30MG/30ML (1MG/ML) | open |