Orange Book product · Brand (NDA)
VARUBI
ROLAPITANT HYDROCHLORIDE
At a glance
Oct 25, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 25, 2017
8 yr 9 mo ago
Today
Patent 7981905 expires
Listed method-of-use patent (U-1741) expiration.
Apr 04, 2027
in 10 mo
Patent 8178550 expires
Listed drug substance patent expiration.
Apr 04, 2027
in 10 mo
Patent 8404702 expires
Listed method-of-use patent (U-1741) expiration.
Apr 04, 2027
in 10 mo
Patent 7049320 expires
Listed drug substance patent expiration.
Aug 19, 2028
in 2 yr 2 mo
Patent 8470842 expires
Listed method-of-use patent (U-1741) expiration.
Jan 18, 2029
in 2 yr 7 mo
Patent 9101615 expires
Listed method-of-use patent (U-1741) expiration.
Jul 14, 2032
in 6 yr 2 mo
Pharmaceutical detail
Active ingredient
ROLAPITANT HYDROCHLORIDE
Strength
EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)
Dosage form
EMULSION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 208399
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7981905 | Apr 04, 2027 | in 10 mo | U-1741 |
| 8178550 | Apr 04, 2027 | in 10 mo | SubstanceProduct |
| 8404702 | Apr 04, 2027 | in 10 mo | U-1741 |
| 7049320 | Aug 19, 2028 | in 2 yr 2 mo | SubstanceProductU-1741 |
| 8470842 | Jan 18, 2029 | in 2 yr 7 mo | U-1741 |
| 9101615 | Jul 14, 2032 | in 6 yr 2 mo | U-1741 |
