cefixime · Lupin Ltd · NDA 050621, 050622, 202091, 203195
Suprax
1 of 2 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US 9233112.
FDA has approved 2 generic applications (ANDAs) for Suprax, though its earliest generic-entry date is 14 Dec 2028 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9233112 | product, use U-1676 | 14 Dec 2028 |
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 · 203195-00123 Mar 2026
- 25 Oct 2026Generic approved · 202091-00114 May 2026
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050621 · 001 · RLD · discontinued | tablet, oral | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050621 · 002 · RLD · discontinued | tablet, oral | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050622 · 001 · RLD · discontinued | for suspension, oral | 100MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 202091 · 001 · RLD | for suspension, oral | 500MG/5ML | 14 Dec 2028 |
| 203195 · 001 · RLD | capsule, oral | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |