duloxetine hydrochloride · Sun Pharm · NDA 212516
Drizalma Sprinkle
Earliest generic entry, as listed · earliest of 4 marketed strengths
13 Apr 2037
Blocked by patent: US 10413525, US 10959982, US 11202772, US 12171742, US 9839626.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10413525 | drug product · sets the listed date | 13 Apr 2037 |
| US 10959982 | drug product · sets the listed date | 13 Apr 2037 |
| US 11202772 | drug product · sets the listed date | 13 Apr 2037 |
| US 12171742 | drug product · sets the listed date | 13 Apr 2037 |
| US 9839626 | drug product · sets the listed date | 13 Apr 2037 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212516 · 001 · RLD | capsule, delayed rel pellets, oral | EQ 20MG BASE | 13 Apr 2037 |
| 212516 · 002 · RLD | capsule, delayed rel pellets, oral | EQ 30MG BASE | 13 Apr 2037 |
| 212516 · 003 · RLD | capsule, delayed rel pellets, oral | EQ 40MG BASE | 13 Apr 2037 |
| 212516 · 004 · RLD | capsule, delayed rel pellets, oral | EQ 60MG BASE | 13 Apr 2037 |