linezolid · Pfizer · NDA 021130, 021131, 021132
Zyvox
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
- 25 Oct 2026Generic approved · 021131-0018 Dec 2025
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021130 · 001 · RLD · discontinued | tablet, oral | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021130 · 002 · RLD · discontinued | tablet, oral | 600MG | open |
| 021131 · 001 · RLD | solution, intravenous | 200MG/100ML (2MG/ML) | open |
| 021131 · 002 · RLD · discontinued | solution, intravenous | 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021131 · 003 · RLD | solution, intravenous | 600MG/300ML (2MG/ML) | open |
| 021132 · 001 · RLD | for suspension, oral | 100MG/5ML | open |