hydromorphone hydrochloride · Fresenius Kabi Usa · NDA 019034
Dilaudid-Hp
Earliest generic entry, as listed
12 Mar 2034
Blocked by patent: US 9248229.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9248229 | drug product · sets the listed date | 12 Mar 2034 |
| US 9731082 | drug product | 23 Apr 2032 |
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 |
|---|---|---|---|
| 019034 · 001 · RLD | injectable, injection | 10MG/ML | 12 Mar 2034 |
| 019034 · 002 · discontinued | injectable, injection | 250MG/VIAL | 12 Mar 2034 |