Viewing data from:

STIVARGA

NDA

REGORAFENIB | N203085 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)TodayIPRPTAB Challenge

2027

2028

2029

2030

2031

2032

Today

Feb. 16, 2031IPR

Jun. 2, 2030

Apr. 8, 2031

Jul. 9, 2032

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2016-01490	8637553	IPR	Fustibal LLC	Institution Denied	2016-07-25	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies NCT06246643	Phase 2	Active	Bayer	13	2024-01-24 → 2028-04-27

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Stivarga (2023)

Total Spending

$111.0M

Total Claims

6,337

Beneficiaries

2,004

Avg Cost/Unit

$273.59

Spending Trend

$101.6M(2019)→$109.1M(2020)→$110.8M(2021)→$118.5M(2022)→$111.0M(2023)

YoY Change:+8.2%

5yr CAGR:+6.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

15 letters from Drugs@FDA

Date	Submission	Document
Feb 5, 2026	SUPPL -18	View Letter (PDF)
Feb 5, 2026	SUPPL -18	View Letter (PDF)
Feb 26, 2025	SUPPL -16	View Letter (PDF)
Apr 13, 2021	SUPPL -14	View Letter (PDF)
Sep 25, 2020	SUPPL -12	View Letter (PDF)
Jul 22, 2020	SUPPL -13	View Letter (PDF)
Feb 14, 2020	SUPPL -11	View Letter (PDF)
Aug 1, 2019	SUPPL -10	View Letter (PDF)
Jun 20, 2018	SUPPL -8	View Letter (PDF)
May 2, 2017	SUPPL -7	View Letter (PDF)
Aug 26, 2016	SUPPL -6	View Letter (PDF)
Jun 8, 2016	SUPPL -5	View Letter (PDF)
Apr 16, 2015	SUPPL -4	View Letter (PDF)
May 31, 2013	SUPPL -1	View Letter (PDF)
Sep 27, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG

RLD

4 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 27, 2012

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8637553	Feb 16, 2031	—	Yes	Yes	—	—
8680124	Jun 2, 2030	—	—	—		—
9458107	Apr 8, 2031	—	—	Yes	—	—
9957232	Jul 9, 2032	—	Yes	—	—	—