magnesium sulfate; potassium chloride; sodium sulfate · Azurity · NDA 213135
Sutab
Blocked by patent: US 10143656, US 11033498, US 11382864, US 11638697.
FDA has approved 1 generic application (ANDA) for Sutab, though its earliest generic-entry date is 4 Aug 2037 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 · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10143656 | drug product · sets the listed date | 4 Aug 2037 |
| US 11033498 | use U-3164 · sets the listed date | 4 Aug 2037 |
| US 11382864 | use U-3164 · sets the listed date | 4 Aug 2037 |
| US 11638697 | drug product · sets the listed date | 4 Aug 2037 |
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
- First generic approved · ANDA 216095, Lupin · 213135-001Approved 28 May 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 216095, Lupin · 213135-001Approved 28 May 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213135 · 001 · RLD | tablet, oral | 0.225GM;0.188GM;1.479GM | 4 Aug 2037 |