FDA Orange Book
Is there a generic for Frindovyx?
Frindovyx contains cyclophosphamide. 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 Frindovyx (cyclophosphamide). The Orange Book shows its last listed patent expires December 1, 2035.
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Frindovyx products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 1GM/2ML (500MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 2GM/4ML (500MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 500MG/ML (500MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 210852, held by AVYXA HOLDINGS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Frindovyx patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10849916 | July 13, 2035 | Drug product | None | 210852 |
| 11382923 | December 1, 2035 | Drug product | None | 210852 |
Frindovyx NDC codes
Questions
Is there a generic for Frindovyx?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Frindovyx (cyclophosphamide). The Orange Book shows its last listed patent expires December 1, 2035.
What is the generic name for Frindovyx?
The active ingredient in Frindovyx is cyclophosphamide, per the FDA Orange Book.
When does the Frindovyx patent expire?
The last patent listed for Frindovyx in the Orange Book expires December 1, 2035. 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.