Question 1

Is there a generic for Technetium tc-99m tilmanocept?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Technetium tc-99m tilmanocept. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Technetium tc-99m tilmanocept?

Accepted Answer

LYMPHOSEEK KIT (NDA 202207, CARDINAL HEALTH 414) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Technetium tc-99m tilmanocept?

Accepted Answer

The Orange Book lists 1 patent against Technetium tc-99m tilmanocept products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Technetium tc-99m tilmanocept are approved?

Accepted Answer

Technetium tc-99m tilmanocept is approved in the following dosage form: injectable.

Technetium tc-99m tilmanocept

Brand (NDA) products · injectable

Listed patents (1)

Technetium tc-99m tilmanocept — frequently asked questions

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