Is there a generic for Pralsetinib?

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

What is the reference-listed drug for Pralsetinib?

GAVRETO (NDA 213721, RIGEL PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Pralsetinib?

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.

Does Pralsetinib have FDA marketing exclusivity?

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.

What dosage forms of Pralsetinib are approved?

Pralsetinib is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Pralsetinib

Pralsetinib: 1 brand, 0 generics; first approved Sep 04, 2020; on patent until Nov 01, 2036.

On patent3 exclusivity periods

Generic status & protection

Protected until Nov 01, 2036 (earliest listed patent expiry).

Earliest patent expiry Nov 01, 2036Latest exclusivity ends Dec 01, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Nov 01, 2036

in 10 yr 5 mo

Originator applications

Brand (NDA) products

GAVRETORLDRS

RIGEL PHARMSNDA 2137212020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (3)

ODE-318Orphan-drug exclusivity (7 years)
Sep 04, 2027
in 1 yr 2 mo
ODE-340Orphan-drug exclusivity (7 years)
Dec 01, 2027
in 1 yr 5 mo
ODE-341Orphan-drug exclusivity (7 years)
Dec 01, 2027
in 1 yr 5 mo

Orange Book patent file

Listed patents

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10030005	Nov 01, 2036	in 10 yr 5 mo	SubstanceProductU-2952
11273160	Apr 03, 2039	in 12 yr 11 mo	U-2952
12539303	Apr 03, 2039	in 12 yr 11 mo	U-2828
11872192	Apr 03, 2039	in 12 yr 11 mo	U-2952
11963958	Apr 03, 2039	in 12 yr 11 mo	U-2828
12448366	Jul 07, 2042	in 16 yr 3 mo	Substance

FDA approval span

Approval history

First approval

Sep 04, 2020

5 yr 11 mo ago

Most recent approval

Sep 04, 2020

5 yr 11 mo ago

All 1 application were approved in 2020.

Brand (NDA) 1100%

Generic (ANDA) 00%

Pralsetinib — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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