Question 1

Is there a generic for Mavorixafor?

Accepted Answer

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

Question 2

What is the reference-listed drug for Mavorixafor?

Accepted Answer

XOLREMDI (NDA 218709, X4 PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Mavorixafor?

Accepted Answer

The Orange Book lists 6 patents against Mavorixafor products, with the earliest listed expiry in 2036. 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 Mavorixafor have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Mavorixafor is approved in the following dosage form: capsule.

Patent	Expires	In	Type
10953003	Dec 14, 2036	in 10 yr 8 mo	Product
11219621	Dec 22, 2036	in 10 yr 8 mo	U-3932
10610527	Dec 22, 2036	in 10 yr 8 mo	U-3932
11045461	Dec 11, 2038	in 12 yr 8 mo	Product
12115156	Dec 11, 2038	in 12 yr 8 mo	Product
10548889	Dec 11, 2038	in 12 yr 8 mo	Product

Mavorixafor

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (6)

Mavorixafor — frequently asked questions

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