gallium ga-68 gozetotide · Univ Ca Los Angeles · NDA 212642, 212643
Gallium Ga 68 Gozetotide
Earliest generic entry, as listed · earliest of 2 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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 216410, Radiomedix · 212642-001Approved 8 Jun 2026Detected 25 Oct 2026Historical import
- First generic approved · ANDA 219189, Ionetix · 212642-001Approved 14 May 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219189, Ionetix · 212642-001Approved 14 May 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212642 · 001 · RLD | solution, intravenous | 0.5-5mCi/ML | open |
| 212643 · 001 · RLD | solution, intravenous | 0.5-5mCi/ML | open |