FDA Orange Book
Is there a generic for Rapiblyk?
Rapiblyk contains landiolol. 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 Rapiblyk (landiolol). The Orange Book shows its last listed patent expires April 25, 2034 and its last listed exclusivity ends November 22, 2029.
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Rapiblyk products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 280MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 217202, held by AOP HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rapiblyk patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10722516 | April 25, 2034 | Method of use | U-4235 | 217202 |
Rapiblyk exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | February 13, 2029 | 217202 |
| NCE | New chemical entity | November 22, 2029 | 217202 |
Rapiblyk NDC codes
Questions
Is there a generic for Rapiblyk?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rapiblyk (landiolol). The Orange Book shows its last listed patent expires April 25, 2034 and its last listed exclusivity ends November 22, 2029.
What is the generic name for Rapiblyk?
The active ingredient in Rapiblyk is landiolol, per the FDA Orange Book.
When does the Rapiblyk patent expire?
The last patent listed for Rapiblyk in the Orange Book expires April 25, 2034. 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.