Viewing data from:

INLYTA

NDA

AXITINIB | N202324 | PF PRISM CV

2 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)TodayPED (+6 mo)

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

Jun. 14, 2031

Aug. 3, 2035

Jul. 12, 2037

Aug. 3, 2035

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

4 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Alkem Laboratories Limited 1:2026cv00623 1 patentANDA 221501axitinib	D. Del.	2026-05-29	Active	—
Pfizer Inc. et al v. Sandoz Inc. 1:2024cv01244	D. Del.	2024-11-12	Terminated 2025-06-18	—
Pfizer Inc. et al v. Glenmark Pharmaceuticals Limited et al 1:2019cv01209 1 patentANDA 213235axitinib	D. Del.	2019-06-26	Terminated 2022-11-23	—
Pfizer Inc. et al v. Apotex Inc. et al 1:2018cv00795 1 patentANDA 211650axitinib	D. Del.	2018-05-25	Terminated 2020-09-28	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

104 trials from ClinicalTrials.gov — 3 recruiting, 6 active, 70 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Pheochromocytoma/Paraganglioma NCT03839498	Phase 2	Active	Columbia University	6	2019-01-22 → 2027-02
Prior Axitinib as a Determinant of Outcome of Renal Surgery NCT03438708	Phase 2	Active	University of California, San Diego	22	2018-03-05 → 2026-03-04
Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma NCT03172754	Phase 1/2	Active	Fox Chase Cancer Center	98	2017-06-12 → 2027-04-06
Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer NCT02912572	Phase 2	Active	Dana-Farber Cancer Institute	106	2016-11-14 → 2026-11
Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer NCT03092856	Phase 2	Active	University of Southern California	62	2017-07-19 → 2027-12-31
A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)NCT03595124	Phase 2	Active	National Cancer Institute (NCI)	15	2019-01-08 → 2026-11-13
Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)NCT03297606	Phase 2	Recruiting	Canadian Cancer Trials Group	720	2018-03-23 → 2027-01-31
The Drug Rediscovery Protocol (DRUP Trial)NCT02925234	Phase 2	Recruiting	The Netherlands Cancer Institute	1,550	2016-08 → 2027-12
ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling NCT04341181	Phase 2	Recruiting	Ulrik Lassen	300	2020-08-24 → 2030-04-30
Axitinib Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractory Third Line Metastatic Colorectal Cancer NCT04355156	Phase 2	Completed	Imperial College London	52	2012-09-17 → 2019-02-22

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$15342.49

Highest Price

$21046.97

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00069-0145-01INLYTA 1 MG TAB	$21046.97	FSS	Pfizer Inc.	06/30/2029
00069-0145-01INLYTA 1 MG TAB	$15342.49	Big4	Pfizer Inc.	06/30/2029
00069-0151-11INLYTA 5MG TAB	$21046.97	FSS	Pfizer Inc.	06/30/2029
00069-0151-11INLYTA 5MG TAB	$15346.01	Big4	Pfizer Inc.	06/30/2029

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

Medicare Part D Spending

CMS annual spending data for Inlyta (2024)

Total Spending

$438.9M

Total Claims

24,770

Beneficiaries

4,465

Avg Cost/Unit

$238.19

Spending Trend

$163.9M(2019)→$263.2M(2020)→$376.1M(2021)→$417.6M(2022)→$466.8M(2023)→$438.9M(2024)

YoY Change:-5.0%

5yr CAGR:+2.7%

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

API Supply Chain7 active DMFs

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

MSN LABORATORIES PRIVATE LTDAXITINIB [ROUTE CODE - "XA"]

DMF 296722015

APOTEX INCAXITINIB

DMF 299182015

SHILPA PHARMA LIFESCIENCES LTDAXITINIB

DMF 301042015

MSN LABORATORIES PRIVATE LTDAXITINIB (FORM-XLI)[ROUTE CODE - "XB"]

DMF 303412016

SYNTHON BVAXITINIB

DMF 379712023

WISDOM PHARMACEUTICAL CO LTDAXITINIB

DMF 393232023

HETERO LABS LTDAXITINIB (FORM-XLI)

DMF 420162025

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jul 17, 2024	SUPPL -16	View Letter (PDF)
Sep 30, 2022	SUPPL -14	View Letter (PDF)
Jun 8, 2020	SUPPL -11	View Letter (PDF)
Jan 24, 2020	SUPPL -10	View Letter (PDF)
Aug 17, 2018	SUPPL -8	View Letter (PDF)
Dec 31, 2014	SUPPL -3	View Letter (PDF)
Aug 4, 2014	SUPPL -2	View Letter (PDF)
Sep 17, 2013	SUPPL -1	View Letter (PDF)
Jan 31, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1MG

RLD

4 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 27, 2012

Patents (4) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8791140	Dec 14, 2030PED: Jun 14, 2031	PED	Yes	—	—	—
10570202	Feb 3, 2035PED: Aug 3, 2035	PED	—	—		—
10869924	Jan 12, 2037PED: Jul 12, 2037	PED	—	—		—
12534530	Feb 3, 2035PED: Aug 3, 2035	PED	—	—		—

#002 — 5MG

RLD

4 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 27, 2012