nicardipine hydrochloride · Chiesi · NDA 019734
Cardene In 4.8% Dextrose In Plastic Container
Blocked by patent: US 7612102, US 9364564.
FDA has approved 2 generic applications (ANDAs) for Cardene In 4.8% Dextrose In Plastic Container, though its earliest generic-entry date is 26 Dec 2027 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7612102 | drug product · sets the listed date | 26 Dec 2027 |
| US 9364564 | drug product · sets the listed date | 26 Dec 2027 |
| US 10758616 | drug 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
- Generic approved · ANDA 219334, Fresenius Kabi Usa · 019734-002Approved 4 Aug 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220243, Caplin · 019734-002Approved 22 Oct 2025Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019734 · 002 · RLD | injectable, intravenous | 20MG/200ML (0.1MG/ML) | 26 Dec 2027 |