Question 1

Is there a generic for Erdafitinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Erdafitinib?

Accepted Answer

BALVERSA (NDA 212018, JANSSEN BIOTECH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Erdafitinib?

Accepted Answer

The Orange Book lists 8 patents against Erdafitinib products, with the earliest listed expiry in 2031. 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 Erdafitinib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Erdafitinib. 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 Erdafitinib are approved?

Accepted Answer

Erdafitinib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
9464071	Apr 28, 2031	in 4 yr 11 mo	U-3805
8895601	Apr 12, 2033	in 6 yr 11 mo	SubstanceProduct
9902714	Mar 26, 2035	in 8 yr 11 mo	Product
12037644	Oct 18, 2035	in 9 yr 6 mo	U-3972
10898482	Feb 09, 2036	in 9 yr 9 mo	ProductU-3066
11684620	Feb 09, 2036	in 9 yr 9 mo	U-3805
10478494	Aug 13, 2036	in 10 yr 4 mo	U-3902
11077106	Feb 02, 2038	in 11 yr 10 mo	U-3196

Erdafitinib

Brand (NDA) products · tablet

Marketing exclusivity (3)

Listed patents (8)

Erdafitinib — frequently asked questions

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