rolapitant hydrochloride · Tersera · NDA 206500, 208399
Varubi
Earliest generic entry, as listed
9 Oct 2029
Blocked by patent: US 8361500.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9101615 | use U-1741 | 14 Jul 2032 |
| US 8361500 | drug product · sets the listed date | 9 Oct 2029 |
| US 8470842 | use U-1741 | 18 Jan 2029 |
| US 7049320 | drug substance, drug product, use U-1741 | 19 Aug 2028 |
| US 7563801 | drug product | 4 Apr 2027 |
| US 7981905 | use U-1741 | 4 Apr 2027 |
| US 8178550 | drug substance, drug product | 4 Apr 2027 |
| US 8404702 | use U-1741 | 4 Apr 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206500 · 001 · RLD | tablet, oral | EQ 90MG BASE | 9 Oct 2029 |
| 208399 · 001 · RLD · discontinued | emulsion, intravenous | EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML) | 14 Jul 2032 |