Question 1

Is there a generic for Pralsetinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Pralsetinib?

Accepted Answer

GAVRETO (NDA 213721, RIGEL 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 Pralsetinib?

Accepted Answer

The Orange Book lists 6 patents against Pralsetinib products, with the earliest listed expiry in 2036. 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 Pralsetinib have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Pralsetinib is approved in the following dosage form: capsule.

Patent	Expires	In	Type
10030005	Nov 01, 2036	in 10 yr 6 mo	SubstanceProductU-2952
11273160	Apr 03, 2039	in 13 yr	U-2952
12539303	Apr 03, 2039	in 13 yr	U-2828
11872192	Apr 03, 2039	in 13 yr	U-2952
11963958	Apr 03, 2039	in 13 yr	U-2828
12448366	Jul 07, 2042	in 16 yr 3 mo	Substance

Pralsetinib

Brand (NDA) products · capsule

Marketing exclusivity (3)

Listed patents (6)

Pralsetinib — frequently asked questions

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