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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Bayer Healthcare LLC et al v. Apotex, Inc. et al 1:2018cv01465	D. Del.	2018-09-21	Terminated 2019-05-14	—
Bayer Healthcare LLC et al v. Apotex Inc. et al 1:2017cv00334	D. Del.	2017-03-28	Terminated 2020-08-17	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

145 trials from ClinicalTrials.gov — 6 recruiting, 7 active, 90 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas NCT02389244	Phase 2	Active	UNICANCER	163	2014-09 → 2026-03-11
Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer NCT04117945	Phase 2	Active	Academic and Community Cancer Research United	22	2020-03-03 → 2025-03-31
An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib NCT02955940	Phase 2	Active	Incyte Corporation	10	2016-11-30 → 2027-09-30
Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer NCT03657641	Phase 1/2	Active	University of Southern California	73	2019-06-21 → 2027-12-31
Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients NCT03829462	Phase 3	Active	Institut du Cancer de Montpellier - Val d'Aurelle	377	2019-03-28 → 2026-09
A Study Using Regorafenib as Second or Third Line Therapy in Metastatic Medullary Thyroid Cancer NCT02657551	Phase 2	Active	Dana-Farber Cancer Institute	8	2016-01 → 2025-12
Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer NCT03844620	Phase 2	Active	M.D. Anderson Cancer Center	100	2019-01-29 → 2026-08-31
A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma NCT03970447	Phase 2/3	Recruiting	Global Coalition for Adaptive Research	2,250	2019-07-30 → 2030-06
Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas NCT04055220	N/A	Recruiting	Centre Leon Berard	168	2020-03-03 → 2026-10-01
A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.NCT04116541	Phase 2	Recruiting	Centre Leon Berard	455	2020-01-28 → 2027-10

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$16981.65

Highest Price

$19783.09

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50419-0171-06STIVARGA 40MG TAB	$19783.09	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0171-06STIVARGA 40MG TAB	$16981.65	Big4	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Stivarga (2024)

Total Spending

$96.4M

Total Claims

5,533

Beneficiaries

1,723

Avg Cost/Unit

$266.34

Spending Trend

$101.6M(2019)→$109.1M(2020)→$110.8M(2021)→$118.5M(2022)→$111.0M(2023)→$96.4M(2024)

YoY Change:-2.6%

5yr CAGR:+4.7%

Source: CMS Medicare Part D Spending by Drug (2024). 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) · 1 use code

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	—	—	—