Orange Book product · Brand (NDA)
VARUBI
ROLAPITANT HYDROCHLORIDE
At a glance
Sep 01, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 01, 2015
10 yr 11 mo ago
Today
Patent 7563801 expires
Listed drug product patent expiration.
Apr 04, 2027
in 10 mo
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 8361500 expires
Listed drug product patent expiration.
Oct 09, 2029
in 3 yr 4 mo
Pharmaceutical detail
Active ingredient
ROLAPITANT HYDROCHLORIDE
Strength
EQ 90MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 206500
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7563801 | Apr 04, 2027 | in 10 mo | Product |
| 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 |
| 8361500 | Oct 09, 2029 | in 3 yr 4 mo | Product |
