sumatriptan succinate · Tonix Meds · NDA 208223
Zembrace Symtouch (Autoinjector)
Blocked by patent: US 10537554, US 11364224, US 12097183.
FDA has approved 1 generic application (ANDA) for Zembrace Symtouch (Autoinjector), though its earliest generic-entry date is 29 Jan 2036 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 · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10537554 | use U-72 · sets the listed date | 29 Jan 2036 |
| US 11364224 | use U-72 · sets the listed date | 29 Jan 2036 |
| US 12097183 | drug product · sets the listed date | 29 Jan 2036 |
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 213518, Alembic · 208223-001Approved 6 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208223 · 001 · RLD | solution, subcutaneous | EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) | 29 Jan 2036 |