amoxicillin · Pragma · NDA 050813
Moxatag
Earliest generic entry, as listed
7 May 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8299052. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8299052 | use U-1304 · sets the listed date | 7 May 2027 |
| US 8357394 | drug product | 8 Dec 2026 |
| US 8778924 | drug substance, drug product, use U-897 | 8 Dec 2026 |
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
- Enters 12-month window basis: patent, carve-out possible · 050813-001Listed date 7 May 2027Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050813 · 001 · RLD · discontinued | tablet, extended release, oral | 775MG | 7 May 2027 |