Question 1

Is there a generic for Tivozanib hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Tivozanib hydrochloride?

Accepted Answer

FOTIVDA (NDA 212904, AVEO 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 Tivozanib hydrochloride?

Accepted Answer

The Orange Book lists 2 patents against Tivozanib hydrochloride 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 Tivozanib hydrochloride have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Tivozanib hydrochloride is approved in the following dosage form: capsule.

Patent	Expires	In	Type
7166722	Nov 16, 2028	in 2 yr 5 mo	SubstanceProduct
11504365	Nov 05, 2039	in 13 yr 7 mo	U-3476

Tivozanib hydrochloride

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (2)

Tivozanib hydrochloride — frequently asked questions

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