zoledronic acid · Novartis · NDA 021223
Zometa
2 of 3 marketed strengths have no unexpired patent or exclusivity listed; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7932241.
FDA has approved 1 generic application (ANDA) for Zometa, though its earliest generic-entry date is 5 Feb 2028 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 · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7932241 | drug product · sets the listed date | 5 Feb 2028 |
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 219984, Gland · 021223-001Approved 5 Feb 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021223 · 001 · RLD · discontinued | injectable, intravenous | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021223 · 002 · RLD · discontinued | injectable, intravenous | EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021223 · 003 · RLD · discontinued | injectable, intravenous | EQ 4MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 5 Feb 2028 |