Question 1

Is there a generic for Cefiderocol sulfate tosylate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Cefiderocol sulfate tosylate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Cefiderocol sulfate tosylate?

Accepted Answer

FETROJA (NDA 209445, SHIONOGI) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Cefiderocol sulfate tosylate?

Accepted Answer

The Orange Book lists 3 patents against Cefiderocol sulfate tosylate 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 Cefiderocol sulfate tosylate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Cefiderocol sulfate tosylate. 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 Cefiderocol sulfate tosylate are approved?

Accepted Answer

Cefiderocol sulfate tosylate is approved in the following dosage form: powder.

Patent	Expires	In	Type
9238657	Nov 14, 2033	in 7 yr 6 mo	SubstanceProductU-282
10004750	Sep 03, 2035	in 9 yr 4 mo	SubstanceProduct
9949982	Sep 03, 2035	in 9 yr 4 mo	Product

Cefiderocol sulfate tosylate

Brand (NDA) products · powder

Marketing exclusivity (2)

Listed patents (3)

Cefiderocol sulfate tosylate — frequently asked questions

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