diazepam · Waylis Therap · NDA 013263, 016087
Valium
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 219882, Baxter Hlthcare Corp · 016087-001Approved 28 Jul 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220365, Lupin · 016087-001Approved 27 Jul 2026Detected 25 Oct 2026Historical import
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 013263 · 002 · RLD | tablet, oral | 2MG | open |
| 013263 · 004 · RLD | tablet, oral | 5MG | open |
| 013263 · 006 · RLD | tablet, oral | 10MG | open |
| 016087 · 001 · RLD · discontinued | injectable, injection | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |