lidocaine · Scilex Pharms · NDA 207962
Ztlido
Blocked by patent: US 10765640, US 10765749, US 11278623, US 11786455, US 11793766, US 9283174, US 9925264, US 9931403.
FDA has approved 2 generic applications (ANDAs) for Ztlido, though its earliest generic-entry date is 10 May 2031 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 · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10765640 | drug product · sets the listed date | 10 May 2031 |
| US 10765749 | drug product · sets the listed date | 10 May 2031 |
| US 11278623 | drug product · sets the listed date | 10 May 2031 |
| US 11786455 | drug product, use U-2267 · sets the listed date | 10 May 2031 |
| US 11793766 | use U-2267 · sets the listed date | 10 May 2031 |
| US 9283174 | drug product · sets the listed date | 10 May 2031 |
| US 9925264 | drug product, use U-2267 · sets the listed date | 10 May 2031 |
| US 9931403 | drug product · sets the listed date | 10 May 2031 |
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 207059, Invagen Pharms · 207962-001Approved 9 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 216484, Alkem Labs Ltd · 207962-001Approved 6 Oct 2025Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207962 · 001 · RLD | patch, topical | 1.8% | 10 May 2031 |