FDA Orange Book
Is there a generic for Rukobia?
Rukobia contains fostemsavir. 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 Rukobia (fostemsavir). The Orange Book shows its last listed patent expires July 13, 2029.
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Rukobia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 600MG BASE | Marketed (Rx) | None | 0 | None |
NDA 212950, held by VIIV HEALTHCARE CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rukobia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7745625 | November 19, 2027 | Drug substance | None | 212950 |
| 8168615 | July 13, 2029 | Drug product | None | 212950 |
Rukobia NDC codes
Questions
Is there a generic for Rukobia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rukobia (fostemsavir). The Orange Book shows its last listed patent expires July 13, 2029.
What is the generic name for Rukobia?
The active ingredient in Rukobia is fostemsavir, per the FDA Orange Book.
When does the Rukobia patent expire?
The last patent listed for Rukobia in the Orange Book expires July 13, 2029. 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.