Question 1

Is there a generic for Cilastatin sodium; imipenem; relebactam?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Cilastatin sodium; imipenem; relebactam. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Cilastatin sodium; imipenem; relebactam?

Accepted Answer

RECARBRIO (NDA 212819, MSD MERCK CO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Cilastatin sodium; imipenem; relebactam?

Accepted Answer

The Orange Book lists 1 patent against Cilastatin sodium; imipenem; relebactam products, with the earliest listed expiry in 2033. 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 Cilastatin sodium; imipenem; relebactam have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Cilastatin sodium; imipenem; relebactam. 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 Cilastatin sodium; imipenem; relebactam are approved?

Accepted Answer

Cilastatin sodium; imipenem; relebactam is approved in the following dosage form: powder.

Cilastatin sodium; imipenem; relebactam

Brand (NDA) products · powder

Marketing exclusivity (3)

Listed patents (1)

Cilastatin sodium; imipenem; relebactam — frequently asked questions

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