magnesium sulfate; potassium sulfate; sodium sulfate · Azurity · NDA 022372
Suprep Bowel Prep Kit
Earliest generic entry, as listed
5 Aug 2027
Blocked by exclusivity: ODE-315.
FDA has approved 1 generic application (ANDA) for Suprep Bowel Prep Kit, though its earliest generic-entry date is 5 Aug 2027 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 · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| ODE-315 | orphan drug (7 years) | 5 Aug 2027 |
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 219429, Macleods Pharms Ltd · 022372-001Approved 31 Aug 2026Detected 25 Oct 2026Historical import
- Enters 12-month window basis: exclusivity · 022372-001Listed date 5 Aug 2027Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022372 · 001 · RLD | solution, oral | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | 5 Aug 2027 |