FDA Orange Book
Is there a generic for Lymphoseek Kit?
Lymphoseek Kit contains technetium tc-99m tilmanocept. 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 Lymphoseek Kit (technetium tc-99m tilmanocept). The Orange Book shows its last listed patent expires January 30, 2029.
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Lymphoseek Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | N/A | Marketed (Rx) | None | 0 | None |
NDA 202207, held by CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lymphoseek Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9439985 | January 30, 2029 | Drug product | None | 202207 |
Questions
Is there a generic for Lymphoseek Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lymphoseek Kit (technetium tc-99m tilmanocept). The Orange Book shows its last listed patent expires January 30, 2029.
What is the generic name for Lymphoseek Kit?
The active ingredient in Lymphoseek Kit is technetium tc-99m tilmanocept, per the FDA Orange Book.
When does the Lymphoseek Kit patent expire?
The last patent listed for Lymphoseek Kit in the Orange Book expires January 30, 2029. 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.