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

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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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
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

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

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial NCT05327686	Phase 2	Recruiting	NRG Oncology	240	2023-02-01 → 2028-06-15
Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study NCT07516132	Phase 3	Recruiting	Ocular Therapeutix, Inc.	850	2026-04-27 → 2030-08-01
A Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma NCT05256472	Phase 2	Completed	Akeso	28	2023-07-06 → 2025-12-31

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

Medicare Part D Spending

CMS annual spending data for Inlyta (2023)

Total Spending

$466.8M

Total Claims

25,243

Beneficiaries

4,739

Avg Cost/Unit

$250.67

Spending Trend

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

YoY Change:+8.9%

5yr CAGR:+4.5%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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	—	—	U-4411	—

#002 — 5MG

RLD

4 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 27, 2012