Question 1

Is there a generic for Technetium tc-99m labeled carbon?

Accepted Answer

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

Question 2

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

Accepted Answer

TECHNEGAS KIT (NDA 022335, CYCLOMEDICA) 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 labeled carbon?

Accepted Answer

The Orange Book lists 1 patent against Technetium tc-99m labeled carbon products, with the earliest listed expiry in 2031. 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

Does Technetium tc-99m labeled carbon have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Technetium tc-99m labeled carbon. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

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

Accepted Answer

Technetium tc-99m labeled carbon is approved in the following dosage form: aerosol.

Technetium tc-99m labeled carbon

Brand (NDA) products · aerosol

Marketing exclusivity (1)

Listed patents (1)

Technetium tc-99m labeled carbon — frequently asked questions

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