Question 1

Is there a generic for Fruquintinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Fruquintinib?

Accepted Answer

FRUZAQLA (NDA 217564, TAKEDA PHARMS USA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Fruquintinib?

Accepted Answer

The Orange Book lists 4 patents against Fruquintinib products, with the earliest listed expiry in 2028. 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 Fruquintinib have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Fruquintinib is approved in the following dosage form: capsule.

Patent	Expires	In	Type
8212033	May 09, 2028	in 1 yr 11 mo	U-3753
7829574	Mar 23, 2032	in 5 yr 10 mo	SubstanceProduct
11046674	Sep 07, 2035	in 9 yr 4 mo	U-3753
10519142	Sep 07, 2035	in 9 yr 4 mo	SubstanceProductU-3753

Fruquintinib

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (4)

Fruquintinib — frequently asked questions

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