gadoterate meglumine · Guerbet · NDA 204781
Dotarem
Earliest generic entry, as listed · earliest of 5 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 219286, Viwit Pharm · 204781-001Approved 10 Aug 2026Detected 25 Oct 2026Historical import
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204781 · 001 · RLD | solution, intravenous | 37.69GM/100ML (376.9MG/ML) | open |
| 204781 · 002 · RLD | solution, intravenous | 3.769GM/10ML (376.9MG/ML) | open |
| 204781 · 003 · RLD | solution, intravenous | 5.6535GM/15ML (376.9MG/ML) | open |
| 204781 · 004 · RLD | solution, intravenous | 7.538GM/20ML (376.9MG/ML) | open |
| 204781 · 005 · RLD | solution, intravenous | 1.8845GM/5ML (376.9MG/ML) | open |