Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2025-00210	11298349	IPR	Azurity Pharmaceuticals, Inc.	Institution Denied	2024-11-18	2025-06-04
IPR2025-00427	12128039	IPR	Azurity Pharmaceuticals, Inc.	Discretionary Denial	2025-01-09	2025-07-02

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

4 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Exelixis, Inc. v. MSN Laboratories Private Limited et al 1:2024cv01208	D. Del.	2024-10-30	Active	—
Exelixis, Inc. v. Cipla Ltd. et al 1:2024cv00565	D. Del.	2024-05-09	Terminated 2024-07-09	—
Exelixis, Inc. v. Teva Pharmaceuticals Development, Inc., et al 1:2022cv01168	D. Del.	2022-09-02	Terminated 2023-09-19	—
Exelixis, Inc. v. MSN Laboratories Private Limited et al 1:2022cv00228	D. Del.	2022-02-23	Terminated 2024-10-23	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

29 trials from ClinicalTrials.gov — 1 recruiting, 11 active, 13 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, RadiCaL Study NCT04071223	Phase 2	Active	National Cancer Institute (NCI)	134	2020-07-29 → 2026-10-01
Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma NCT02243605	Phase 2	Active	National Cancer Institute (NCI)	90	2014-12-19 → 2026-07-11
Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer NCT01708954	Phase 2	Active	National Cancer Institute (NCI)	125	2013-02-13 → 2027-03-31
Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors NCT04079712	Phase 2	Active	National Cancer Institute (NCI)	17	2020-08-06 → 2026-08-19
Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer NCT03914300	Phase 2	Active	National Cancer Institute (NCI)	11	2020-02-10 → 2026-12-17
Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer NCT03367741	Phase 2	Active	National Cancer Institute (NCI)	82	2018-04-16 → 2026-07-23
Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer NCT04310007	Phase 2	Active	National Cancer Institute (NCI)	117	2020-07-13 → 2026-12-31
Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors NCT02867592	Phase 2	Active	National Cancer Institute (NCI)	109	2017-05-18 → 2026-06-27
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors NCT03375320	Phase 3	Active	National Cancer Institute (NCI)	298	2018-10-26 → 2026-08-19
Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma NCT04339738	Phase 2	Active	National Cancer Institute (NCI)	90	2020-11-04 → 2027-01-21

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$14506.34

Highest Price

$19087.29

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42388-0013-14COMETRIQ 60MG CAP	$19087.29	FSS	Exelixis, Inc.	07/14/2027
42388-0013-14COMETRIQ 60MG CAP	$14506.34	Big4	Exelixis, Inc.	07/14/2027
42388-0012-14COMETRIQ 100MG CAP	$19087.29	FSS	Exelixis, Inc.	07/14/2027
42388-0012-14COMETRIQ 100MG CAP	$14506.34	Big4	Exelixis, Inc.	07/14/2027
42388-0011-14COMETRIQ 140MG CAP	$19087.29	FSS	Exelixis, Inc.	07/14/2027
42388-0011-14COMETRIQ 140MG CAP	$14506.34	Big4	Exelixis, Inc.	07/14/2027

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

Medicare Part D Spending

CMS annual spending data for Cometriq (2024)

Total Spending

$3.3M

Total Claims

202

Beneficiaries

Avg Cost/Unit

$244.31

Spending Trend

$8.5M(2019)→$9.1M(2020)→$5.8M(2021)→$4.0M(2022)→$3.5M(2023)→$3.3M(2024)

YoY Change:-2.6%

5yr CAGR:+0.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

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

FERMION OYCABOZANTINIB S-MALATE

DMF 344372020

CHANGZHOU PHARMACEUTICAL FACTORYCABOZANTINIB

DMF 432952025

SHANGHAI HUILUN PHARMACEUTICAL CO LTDCABOZANTINIB S-MALATE

DMF 435042026

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Oct 10, 2025	SUPPL -13	View Letter (PDF)
Aug 24, 2023	SUPPL -11	View Letter (PDF)
Oct 23, 2020	SUPPL -9	View Letter (PDF)
Feb 4, 2020	SUPPL -8	View Letter (PDF)
Jan 17, 2018	SUPPL -5	View Letter (PDF)
Oct 6, 2017	SUPPL -4	View Letter (PDF)
May 24, 2016	SUPPL -2	View Letter (PDF)
Nov 30, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 20MG BASE

RLD

8 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 29, 2012

Patents (8) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7579473	Aug 14, 2026	—	Yes	Yes	—	—
8877776	Oct 8, 2030	—	Yes	Yes		—
9717720	Feb 10, 2032	—	—	Yes	—	—
11091439	Jan 15, 2030	—	Yes	—	—	—
11091440	Jan 15, 2030	—	—	Yes	—	—
11098015	Jan 15, 2030	—	—	—		—
11298349	Feb 10, 2032	—	—	Yes	—	—
12128039	Feb 10, 2032	—	—	Yes		—

#002 — EQ 80MG BASE

RLD

8 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 29, 2012