phenylephrine hydrochloride · Hikma · NDA 203826
Immphentiv
Earliest generic entry, as listed · earliest of 2 marketed strengths
26 Sep 2036
Blocked by patent: US 11213480, US 12257342.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11213480 | product | 26 Sep 2036 |
| US 12257342 | product | 26 Sep 2036 |
| US 11471400 | product | 5 Aug 2036 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203826 · 004 · RLD | solution, intravenous | 0.5MG/5ML (0.1MG/ML) | 26 Sep 2036 |
| 203826 · 005 · RLD | solution, intravenous | 1MG/10ML (0.1MG/ML) | 26 Sep 2036 |