diclofenac sodium · Javelin Pharms Inc · NDA 022396
Dyloject
Earliest generic entry, as listed
22 Mar 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8946292. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8946292 | use U-1659 · sets the listed date | 22 Mar 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, carve-out possible · 022396-001Listed date 22 Mar 2027Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022396 · 001 · RLD · discontinued | solution, intravenous | 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 22 Mar 2027 |