FDA Orange Book · active-ingredient family
Rolapitant hydrochloride
Rolapitant hydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VARUBI · NDA 208399
2
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · emulsion, tablet
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7981905 | Apr 04, 2027 | in 10 mo | U-1741 |
| 8404702 | Apr 04, 2027 | in 10 mo | U-1741 |
| 8178550 | Apr 04, 2027 | in 10 mo | SubstanceProduct |
| 7563801 | Apr 04, 2027 | in 10 mo | Product |
| 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 |
| 9101615 | Jul 14, 2032 | in 6 yr 2 mo | U-1741 |
Rolapitant hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
