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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.

STIVARGA

NDANot in Orange Book

REGORAFENIB | N204369 | BAYER HEALTHCARE PHARMS

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 Chain8 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDREGORAFENIB [ROUTE CODE "RZ"]

DMF 298702015

HETERO LABS LTDREGORAFENIB

DMF 304902016

MSN LABORATORIES PRIVATE LTDREGORAFENIB MONOHYDRATE USP

DMF 368382022

CHONGQING CARELIFE PHARMACEUTICAL CO LTDREGORAFENIB

DMF 381972023

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDREGORAFENIB

DMF 398982024

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDREGORAFENIB ANHYDRATE NON-STERILE DRUG SUBSTANCE

DMF 412902025

SHANDONG ANHONG PHARMACEUTICAL CO LTDREGORAFENIB

DMF 415962025

SICHUAN KELUN PHARMACEUTICAL CO LTDREGORAFENIB

DMF 428422025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 26, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG

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TABLET; ORAL | Approved: Feb. 25, 2013

No patent or exclusivity listings for this strength.