bumetanide · Validus Pharms · NDA 018225, 018226
Bumex
Earliest generic entry, as listed · earliest of 3 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 215362, Msn · 018225-001Approved 5 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220427, Adaptis · 018226-001Approved 26 Feb 2026Detected 25 Oct 2026Historical import
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018225 · 001 · RLD | tablet, oral | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018225 · 002 · RLD | tablet, oral | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018225 · 003 · RLD | tablet, oral | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018226 · 001 · RLD · discontinued | injectable, injection | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |