Question 1

Is there a generic for Avibactam sodium; ceftazidime?

Accepted Answer

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

Question 2

What is the reference-listed drug for Avibactam sodium; ceftazidime?

Accepted Answer

AVYCAZ (NDA 206494, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Avibactam sodium; ceftazidime?

Accepted Answer

The Orange Book lists 7 patents against Avibactam sodium; ceftazidime products, with the earliest listed expiry in 2026. 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 Avibactam sodium; ceftazidime have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Avibactam sodium; ceftazidime. 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 Avibactam sodium; ceftazidime are approved?

Accepted Answer

Avibactam sodium; ceftazidime is approved in the following dosage form: powder.

Patent	Expires	In	Type
7112592	Jan 07, 2026	5 mo ago	SubstanceProductU-2508
7612087	Nov 12, 2026	in 5 mo	Product
8835455	Oct 08, 2030	in 4 yr 4 mo	Product
8471025	Aug 12, 2031	in 5 yr 3 mo	Substance
9284314	Jun 15, 2032	in 6 yr 1 mo	Substance
8969566	Jun 15, 2032	in 6 yr 1 mo	Substance
9695122	Jun 15, 2032	in 6 yr 1 mo	Substance

Avibactam sodium; ceftazidime

Brand (NDA) products · powder

Marketing exclusivity (1)

Listed patents (7)

Avibactam sodium; ceftazidime — frequently asked questions

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