Question 1

Is there a generic for Infigratinib phosphate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Infigratinib phosphate?

Accepted Answer

TRUSELTIQ (NDA 214622, HELSINN HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Infigratinib phosphate?

Accepted Answer

The Orange Book lists 4 patents against Infigratinib phosphate 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 Infigratinib phosphate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 4 marketing-exclusivity periods for Infigratinib phosphate. 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 Infigratinib phosphate are approved?

Accepted Answer

Infigratinib phosphate is approved in the following dosage form: capsule.

Patent	Expires	In	Type
9067896	Aug 06, 2028	in 2 yr 2 mo	Substance
8552002	Aug 25, 2029	in 3 yr 3 mo	SubstanceProduct
10278969	Dec 11, 2034	in 8 yr 7 mo	Product
11160804	Dec 11, 2034	in 8 yr 7 mo	Product

Infigratinib phosphate

Brand (NDA) products · capsule

Marketing exclusivity (4)

Listed patents (4)

Infigratinib phosphate — frequently asked questions

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