FDA Orange Book
Is there a generic for Vyndamax?
Vyndamax contains tafamidis. 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 Vyndamax (tafamidis). The Orange Book shows its last listed patent expires August 31, 2035 and its last listed exclusivity ends May 3, 2026.
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Vyndamax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 61MG | Marketed (Rx) | None | 0 | None |
NDA 212161, held by FOLDRX PHARMACEUTICALS LLC A WHOLLY OWNED SUB OF PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vyndamax patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7214696 | December 19, 2026 | Method of use | U-2524 | 212161 |
| 7214695 | December 19, 2026 | Drug substance, Drug product | None | 212161 |
| 9770441 | August 31, 2035 | Drug substance, Drug product | U-2524 | 212161 |
Vyndamax exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-237 | Orphan drug exclusivity | May 3, 2026 | 212161 |
Vyndamax NDC codes
Questions
Is there a generic for Vyndamax?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vyndamax (tafamidis). The Orange Book shows its last listed patent expires August 31, 2035 and its last listed exclusivity ends May 3, 2026.
What is the generic name for Vyndamax?
The active ingredient in Vyndamax is tafamidis, per the FDA Orange Book.
When does the Vyndamax patent expire?
The last patent listed for Vyndamax in the Orange Book expires August 31, 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.