potassium chloride · Genus Lifesciences · NDA 007865, 019439, 206814, 208019
Potassium Chloride
1 of 3 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US 12539314, US 12728138.
FDA has approved 2 generic applications (ANDAs) for Potassium Chloride, though its earliest generic-entry date is 7 Mar 2039 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 · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12539314 | drug product · sets the listed date | 7 Mar 2039 |
| US 12728138 | drug product · sets the listed date | 7 Mar 2039 |
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 215716, Quagen · 206814-001Approved 22 Dec 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 216536, Aurobindo Pharma · 206814-001Approved 20 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 007865 · 002 · discontinued | injectable, injection | 2MEQ/ML | open |
| 019439 · 001 · RLD · discontinued | tablet, extended release, oral | 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019439 · 002 · RLD · discontinued | tablet, extended release, oral | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 206814 · 001 · RLD | solution, oral | 20MEQ/15ML | 7 Mar 2039 |
| 206814 · 002 · RLD | solution, oral | 40MEQ/15ML | 7 Mar 2039 |
| 208019 · 001 · RLD | for solution, oral | 20MEQ | open |
| 208019 · 003 · RLD · discontinued | for solution, oral | 40MEQ | open |