netupitant; palonosetron hydrochloride · Helsinn Hlthcare · NDA 205718, 210493
Akynzeo
Earliest generic entry, as listed · earliest of 2 marketed strengths
25 Sep 2035
Other strengths are listed to 2 Jun 2037.
Blocked by patent: US 10233154, US 10676440, US 10961195, US 9951016.
Listed patents · 22 unexpired
24 Orange Book listing rows for 22 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10624911 | drug product | 2 Jun 2037 |
| US 11529362 | drug product | 2 Jun 2037 |
| US 12208109 | drug product | 2 Jun 2037 |
| US 10233154 | drug substance · sets the listed date | 25 Sep 2035 |
| US 10676440 | drug substance, drug product · sets the listed date | 25 Sep 2035 |
| US 10961195 | drug substance, drug product · sets the listed date | 25 Sep 2035 |
| US 9951016 | drug substance, drug product · sets the listed date | 25 Sep 2035 |
| US 10208073 | use U-2301 | 23 May 2032 |
| US 10717721 | drug substance | 23 May 2032 |
| US 11312698 | drug substance, drug product | 23 May 2032 |
| US 8426450 | drug substance, drug product | 23 May 2032 |
| US 8895586 | use U-2301 | 23 May 2032 |
| US 9403772 | drug substance, use U-2301 | 23 May 2032 |
| US 9908907 | drug substance, drug product | 23 May 2032 |
| US 9271975 | use U-2293 | 9 Sep 2031 |
| US 10828297 | use U-2293, U-2301 | 17 Dec 2030 |
| US 10828297 listing row | use U-2293 | 17 Dec 2030 |
| US 10828297 listing row | use U-2301 | 17 Dec 2030 |
| US 11559523 | drug product, use U-3522 | 18 Nov 2030 |
| US 12042494 | drug product, use U-3522 | 18 Nov 2030 |
| US 8623826 | use U-2293 | 18 Nov 2030 |
| US 8951969 | drug product | 18 Nov 2030 |
| US 9186357 | use U-2293, U-2301 | 18 Nov 2030 |
| US 9186357 listing row | use U-2293 | 18 Nov 2030 |
| US 9186357 listing row | use U-2301 | 18 Nov 2030 |
| US 9943515 | use U-2293 | 18 Nov 2030 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205718 · 001 · RLD | capsule, oral | 300MG;EQ 0.5MG BASE | 25 Sep 2035 |
| 210493 · 001 · RLD · discontinued | powder, intravenous | EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL | 2 Jun 2037 |
| 210493 · 002 · RLD | solution, intravenous | EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) | 2 Jun 2037 |