fomepizole · Par Pharm Inc · NDA 020696
Antizol
Earliest generic entry, as listed
30 Jun 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7553863.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7553863 | drug substance, drug product · sets the listed date | 30 Jun 2027 |
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 · 020696-001Listed date 30 Jun 2027Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020696 · 001 · RLD · discontinued | injectable, injection | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 30 Jun 2027 |