hydromorphone hydrochloride · Hospira Inc · NDA 200403, 217812
Hydromorphone Hydrochloride
Earliest generic entry, as listed · earliest of 6 marketed strengths
10 Jan 2043
5 of 6 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 12653820.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12653820 | product, use U-4571 | 10 Jan 2043 |
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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 200403 · 001 · RLD | injectable, injection | 1MG/ML | open |
| 200403 · 002 · RLD | injectable, injection | 2MG/ML | open |
| 200403 · 003 · RLD | injectable, injection | 4MG/ML | open |
| 200403 · 004 · RLD | injectable, injection | 0.5MG/0.5ML | open |
| 200403 · 005 · RLD | injectable, injection | 0.25MG/0.5ML | open |
| 217812 · 001 · RLD | solution, intramuscular, intravenous, subcutaneous | 40MG/20ML (2MG/ML) | 10 Jan 2043 |