FDA Orange Book
Is there a generic for Beizray?
Beizray contains docetaxel. 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 Beizray (docetaxel). The Orange Book shows its last listed patent expires May 16, 2036.
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Beizray products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 20MG/ML (20MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 80MG/4ML (20MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 218711, held by ZHUHAI BEIHAI BIOTECH CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Beizray patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12090134 | May 16, 2036 | Drug product | U-946 | 218711 |
| 12090134 | May 16, 2036 | Drug product | U-881 | 218711 |
| 12090134 | May 16, 2036 | Drug product | U-937 | 218711 |
| 12090134 | May 16, 2036 | Drug product | U-4027 | 218711 |
| 12090134 | May 16, 2036 | Drug product | U-4028 | 218711 |
| 11419842 | May 16, 2036 | Drug product | U-946 | 218711 |
| 11419842 | May 16, 2036 | Drug product | U-881 | 218711 |
| 11419842 | May 16, 2036 | Drug product | U-937 | 218711 |
| 11419842 | May 16, 2036 | Drug product | U-4027 | 218711 |
| 11419842 | May 16, 2036 | Drug product | U-4028 | 218711 |
| 12090135 | May 16, 2036 | Drug product | None | 218711 |
Beizray NDC codes
Questions
Is there a generic for Beizray?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Beizray (docetaxel). The Orange Book shows its last listed patent expires May 16, 2036.
What is the generic name for Beizray?
The active ingredient in Beizray is docetaxel, per the FDA Orange Book.
When does the Beizray patent expire?
The last patent listed for Beizray in the Orange Book expires May 16, 2036. 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.