hydromorphone hydrochloride · Fresenius Kabi Usa · NDA 019034, 019891, 019892
Dilaudid
Earliest generic entry, as listed · earliest of 9 marketed strengths
12 Mar 2034
4 of 9 marketed strengths have no unexpired patent or exclusivity listed.
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 · 9
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019034 · 003 · RLD | injectable, injection | 1MG/ML | 12 Mar 2034 |
| 019034 · 004 · RLD | injectable, injection | 2MG/ML | 12 Mar 2034 |
| 019034 · 005 · RLD | injectable, injection | 4MG/ML | 12 Mar 2034 |
| 019034 · 006 · RLD | injectable, injection | 0.2MG/ML | 12 Mar 2034 |
| 019034 · 007 · RLD | injectable, injection | 0.5MG/0.5ML | 12 Mar 2034 |
| 019891 · 001 · RLD | solution, oral | 5MG/5ML | open |
| 019892 · 001 · RLD | tablet, oral | 8MG | open |
| 019892 · 002 · RLD | tablet, oral | 4MG | open |
| 019892 · 003 · RLD | tablet, oral | 2MG | open |