nicardipine hydrochloride · Chiesi · NDA 019734
Cardene In 4.8% Dextrose In Plastic Container
Earliest generic entry, as listed
26 Dec 2027
Blocked by patent: US 7612102, US 9364564.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7612102 | product | 26 Dec 2027 |
| US 9364564 | product | 26 Dec 2027 |
| US 10758616 | product | 18 Apr 2027 |
| US 11547758 | use U-1029 | 18 Apr 2027 |
| US 7659291 | use U-1029 | 18 Apr 2027 |
| US 8455524 | use U-1029 | 18 Apr 2027 |
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
- 25 Oct 2026Generic approved · 019734-0024 Aug 2026
- 25 Oct 2026Generic approved · 019734-00222 Oct 2025
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019734 · 002 · RLD | injectable, intravenous | 20MG/200ML (0.1MG/ML) | 26 Dec 2027 |