gadobutrol · Bayer Hlthcare · NDA 201277
Gadavist
Earliest generic entry, as listed · earliest of 6 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 215957, Ge Hlthcare · 201277-001Approved 29 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219287, Viwit Pharm · 201277-001Approved 11 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219146, Zenara · 201277-001Approved 8 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 201277 · 001 · RLD | solution, intravenous | 4.5354GM/7.5ML (604.72MG/ML) | open |
| 201277 · 002 · RLD | solution, intravenous | 6.0472GM/10ML (604.72MG/ML) | open |
| 201277 · 003 · RLD | solution, intravenous | 9.0708GM/15ML (604.72MG/ML) | open |
| 201277 · 004 · RLD | solution, intravenous | 18.1416GM/30ML (604.72MG/ML) | open |
| 201277 · 005 · RLD | solution, intravenous | 39.3068GM/65ML (604.72MG/ML) | open |
| 201277 · 006 · RLD | solution, intravenous | 1.20944GM/2ML (604.72MG/ML) | open |