Question 1

Is there a generic for Ibrexafungerp citrate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Ibrexafungerp citrate?

Accepted Answer

BREXAFEMME (NDA 214900, GLAXOSMITHKLINE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Ibrexafungerp citrate?

Accepted Answer

The Orange Book lists 5 patents against Ibrexafungerp citrate products, with the earliest listed expiry in 2030. 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 Ibrexafungerp citrate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Ibrexafungerp citrate. 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 Ibrexafungerp citrate are approved?

Accepted Answer

Ibrexafungerp citrate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8188085	Aug 28, 2030	in 4 yr 3 mo	SubstanceProductU-3159
10370406	Jan 19, 2035	in 8 yr 9 mo	U-3159
10927142	Jan 19, 2035	in 8 yr 9 mo	Substance
10174074	Jan 19, 2035	in 8 yr 9 mo	SubstanceProduct
11534433	Jun 10, 2039	in 13 yr 2 mo	U-3159

Ibrexafungerp citrate

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (5)

Ibrexafungerp citrate — frequently asked questions

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