FDA Orange Book
Is there a generic for Beqalzi?
Beqalzi contains sonrotoclax. 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 Beqalzi (sonrotoclax). The Orange Book shows its last listed patent expires April 29, 2039 and its last listed exclusivity ends May 13, 2031.
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Beqalzi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 20MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 80MG | Marketed (Rx) | None | 0 | None |
NDA 220711, held by BEONE MEDICINES USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Beqalzi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11420968 | April 29, 2039 | Drug substance, Drug product | None | 220711 |
Beqalzi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 13, 2031 | 220711 |
Beqalzi NDC codes
Questions
Is there a generic for Beqalzi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Beqalzi (sonrotoclax). The Orange Book shows its last listed patent expires April 29, 2039 and its last listed exclusivity ends May 13, 2031.
What is the generic name for Beqalzi?
The active ingredient in Beqalzi is sonrotoclax, per the FDA Orange Book.
When does the Beqalzi patent expire?
The last patent listed for Beqalzi in the Orange Book expires April 29, 2039. 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.