FDA Orange Book
Is there a generic for Varubi?
Varubi contains rolapitant. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Varubi (rolapitant). The Orange Book shows its last listed patent expires July 14, 2032.
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Varubi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| emulsion, intravenous | EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML) | Discontinued | None | 0 | None |
| tablet, oral | EQ 90MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208399, 206500, held by TERSERA THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Varubi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7981905 | April 4, 2027 | Method of use | U-1741 | 208399 |
| 8404702 | April 4, 2027 | Method of use | U-1741 | 208399 |
| 8178550 | April 4, 2027 | Drug substance, Drug product | None | 208399 |
| 7563801 | April 4, 2027 | Drug product | None | 206500 |
| 7049320 | August 19, 2028 | Drug substance, Drug product | U-1741 | 208399 |
| 8470842 | January 18, 2029 | Method of use | U-1741 | 208399 |
| 8361500 | October 9, 2029 | Drug product | None | 206500 |
| 9101615 | July 14, 2032 | Method of use | U-1741 | 208399 |
Varubi NDC codes
Questions
Is there a generic for Varubi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Varubi (rolapitant). The Orange Book shows its last listed patent expires July 14, 2032.
What is the generic name for Varubi?
The active ingredient in Varubi is rolapitant, per the FDA Orange Book.
When does the Varubi patent expire?
The last patent listed for Varubi in the Orange Book expires July 14, 2032. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.