aprepitant · Msd · NDA 021549, 022023, 207865
Emend
Earliest generic entry, as listed · earliest of 3 marketed strengths
26 Sep 2027
1 of 3 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US 8258132.
Listed patents · 1 unexpired
3 Orange Book listing rows for 1 patent. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8258132 | drug product, use U-1743, U-1916, U-901 | 26 Sep 2027 |
| US 8258132 listing row | drug product, use U-1743 · sets the listed date | 26 Sep 2027 |
| US 8258132 listing row | drug product, use U-1916 · sets the listed date | 26 Sep 2027 |
| US 8258132 listing row | drug product, use U-901 · sets the listed date | 26 Sep 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
- 24 Oct 2026Enters 12-month window basis: patent · 207865-00126 Sep 2027
- 24 Oct 2026Enters 12-month window basis: patent · 021549-00226 Sep 2027
- 24 Oct 2026Enters 12-month window basis: patent · 021549-00126 Sep 2027
- 24 Oct 2026Enters 12-month window basis: patent · 021549-00326 Sep 2027
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021549 · 001 · RLD | capsule, oral | 80MG | 26 Sep 2027 |
| 021549 · 002 · RLD | capsule, oral | 125MG | 26 Sep 2027 |
| 021549 · 003 · RLD · discontinued | capsule, oral | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 26 Sep 2027 |
| 022023 · 001 · RLD · discontinued | powder, intravenous | EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 022023 · 002 · RLD | powder, intravenous | EQ 150MG BASE/VIAL | open |
| 207865 · 001 · RLD · discontinued | for suspension, oral | 125MG/KIT | 26 Sep 2027 |