cephalexin · Pragma · NDA 050405, 050406
Keflex
Earliest generic entry, as listed · earliest of 7 marketed strengths
Open now
No marketed reference-listed strength; date taken from all listed strengths.
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 · 050406-0019 Jun 2026
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050405 · 002 · RLD · discontinued | capsule, oral | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050405 · 003 · RLD · discontinued | capsule, oral | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050405 · 004 · RLD · discontinued | capsule, oral | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050405 · 005 · RLD · discontinued | capsule, oral | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050406 · 001 · RLD · discontinued | for suspension, oral | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050406 · 002 · RLD · discontinued | for suspension, oral | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | open |
| 050406 · 003 · RLD · discontinued | for suspension, oral | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | open |