Question 1

Is there a generic for Motixafortide acetate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Motixafortide acetate?

Accepted Answer

APHEXDA (NDA 217159, AYRMID PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Motixafortide acetate?

Accepted Answer

The Orange Book lists 2 patents against Motixafortide acetate products, with the earliest listed expiry in 2041. 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 Motixafortide acetate have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Motixafortide acetate is approved in the following dosage form: powder.

Patent	Expires	In	Type
12257285	Dec 29, 2041	in 15 yr 9 mo	Product
12268725	Dec 29, 2041	in 15 yr 9 mo	Product

Motixafortide acetate

Brand (NDA) products · powder

Marketing exclusivity (2)

Listed patents (2)

Motixafortide acetate — frequently asked questions

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