chlorthalidone · Prm Pharma · NDA 218647
Hemiclor
Earliest generic entry, as listed
4 Sep 2045
Blocked by patent: US 12667554.
FDA has approved 1 generic application (ANDA) for Hemiclor, though its earliest generic-entry date is 4 Sep 2045 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 12667554 | drug product · sets the listed date | 4 Sep 2045 |
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
- Generic approved · ANDA 212229, Macleods Pharms · 218647-001Approved 1 Jul 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218647 · 001 · RLD | tablet, oral | 12.5MG | 4 Sep 2045 |