Viewing data from:

Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

GAVRETO

NDANot in Orange Book

PRALSETINIB | N214701 | BLUEPRINT MEDICINES

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

OLON SPAPRALSETINIB

DMF 396592024

VALARY LAB PRIVATE LIMITEDPRALSETINIB

DMF 398142024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 2, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

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CAPSULE;ORAL | Approved: Dec. 1, 2020

No patent or exclusivity listings for this strength.