Viewing data from:

SUTENT

NDA

SUNITINIB MALATE | N021938 | CP PHARMACEUTICALS INTERNATIONAL CV

4 strengths0 unique patents0 unique exclusivities

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Mylan Inc. et al 1:2010cv00528 3 patentsANDA 201275Sunitinib Malate	D. Del.	2010-06-16	Terminated 2014-10-23	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors NCT05489237	Phase 1	Active	IDRX, Inc., a wholly owned subsidiary of GSK, LLC	276	2022-08-03 → 2027-03-26
An Exploratory Study on the Use of Ipalotinib (Tislelizumab) Combined With Sunitinib and Olaparib for Neoadjuvant Therapy in HRD-positive Advanced Ovarian Cancer NCT07667751	Phase 2	Recruiting	Bai-Rong Xia	35	2026-06-01 → 2027-12-31
Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors NCT06948955	—	AVAILABLE	Cogent Biosciences, Inc.	—	—
Validation of a Predictive Nomogram of Response or Resistance to Targeted Therapies in Metastatic Clear Cell Renal Cell Carcinoma NCT02848768	—	Completed	Rennes University Hospital	45	2014-12 → 2017-09-21
Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy NCT00693992	Phase 3	Completed	National Cancer Institute (NCI)	210	2008-06-15 → 2015-05-28

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

Medicare Part D Spending

CMS annual spending data for Sutent (2023)

Total Spending

$7.4M

Total Claims

632

Beneficiaries

124

Avg Cost/Unit

$505.59

Spending Trend

$160.5M(2019)→$120.2M(2020)→$97.0M(2021)→$17.6M(2022)→$7.4M(2023)

YoY Change:-5.2%

5yr CAGR:-0.3%

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

API Supply Chain8 active DMFs2 inactive

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

TAPI NL BVSUNITINIB MALATE

DMF 234142009

RELIANCE LIFE SCIENCES PVT LTDSUNITINIB MALATE

DMF 290142015

SHILPA MEDICARE LTDSUNITINIB

DMF 296532021

MEDICHEM MANUFACTURING (MALTA) LTDSUNITINIB MALATE

DMF 305592016

SHILPA PHARMA LIFESCIENCES LTDSUNITINIB MALATE

DMF 330852018

MSN LABORATORIES PRIVATE LTDSUNITINIB MALATE

DMF 333082018

HETERO LABS LTDSUNITINIB MALATE

DMF 362012021

CDYMAX (INDIA) PHARMA PRIVATE LTDSUNITINIB MALATE

DMF 363922021

MYLAN LABORATORIES LTDInactiveSUNITINIB MALATE

DMF 245092010

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveSUNITINIB MALATE

DMF 264642012

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

Approval Letters

34 letters from Drugs@FDA

Date	Submission	Document
Sep 9, 2021	SUPPL -39	View Letter (PDF)
Aug 17, 2020	SUPPL -37	View Letter (PDF)
Jul 13, 2020	SUPPL -38	View Letter (PDF)
May 13, 2019	SUPPL -36	View Letter (PDF)
Dec 20, 2018	SUPPL -35	View Letter (PDF)
Nov 17, 2017	SUPPL -33	View Letter (PDF)
Nov 17, 2015	SUPPL -31	View Letter (PDF)
Apr 27, 2015	SUPPL -28	View Letter (PDF)
Apr 27, 2015	SUPPL -29	View Letter (PDF)
Dec 23, 2014	SUPPL -27	View Letter (PDF)
Jun 12, 2014	SUPPL -26	View Letter (PDF)
Sep 4, 2013	SUPPL -24	View Letter (PDF)
Sep 4, 2013	SUPPL -25	View Letter (PDF)
Nov 19, 2012	SUPPL -23	View Letter (PDF)
Nov 19, 2012	SUPPL -21	View Letter (PDF)
Nov 19, 2012	SUPPL -22	View Letter (PDF)
Apr 24, 2012	SUPPL -19	View Letter (PDF)
Apr 24, 2012	SUPPL -20	View Letter (PDF)
May 25, 2011	SUPPL -17	View Letter (PDF)
May 25, 2011	SUPPL -13	View Letter (PDF)
May 25, 2011	SUPPL -18	View Letter (PDF)
Sep 22, 2010	SUPPL -7	View Letter (PDF)
Sep 22, 2010	SUPPL -6	View Letter (PDF)
Sep 22, 2010	SUPPL -8	View Letter (PDF)
Jul 6, 2010	SUPPL -14	View Letter (PDF)
Jul 6, 2010	SUPPL -11	View Letter (PDF)
Jul 6, 2010	SUPPL -15	View Letter (PDF)
Jul 6, 2010	SUPPL -10	View Letter (PDF)
Apr 3, 2009	SUPPL -9	View Letter (PDF)
Feb 12, 2007	SUPPL -5	View Letter (PDF)
Feb 12, 2007	SUPPL -3	View Letter (PDF)
Feb 12, 2007	SUPPL -2	View Letter (PDF)
Feb 12, 2007	SUPPL -4	View Letter (PDF)
Jan 30, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 12.5MG BASE

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 26, 2006

No patent or exclusivity listings for this strength.

#002 — EQ 25MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 26, 2006

#003 — EQ 50MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 26, 2006

#004 — EQ 37.5MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 31, 2009