Axitinib Patent Expiration

Axitinib is Used for the treatment of advanced renal cell carcinoma, typically in combination with other medications like avelumab or pembrolizumab. It was first introduced by Pf Prism Cv in its drug Inlyta on Jan 27, 2012. 2 different companies have introduced drugs containing Axitinib.


Axitinib Patents

Given below is the list of patents protecting Axitinib, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Inlyta US10869924

(Pediatric)

PD-L1 antagonist combination treatments Jul 12, 2037 Pf Prism Cv
Inlyta US10869924 PD-L1 antagonist combination treatments Jan 12, 2037 Pf Prism Cv
Inlyta US10570202

(Pediatric)

Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer Aug 03, 2035 Pf Prism Cv
Inlyta US12534530

(Pediatric)

Combination Of A Pd-1 Antagonist And A Vegfr Inhibitor For Treating Cancer Aug 03, 2035 Pf Prism Cv
Inlyta US10570202 Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer Feb 03, 2035 Pf Prism Cv
Inlyta US12534530 Combination Of A Pd-1 Antagonist And A Vegfr Inhibitor For Treating Cancer Feb 03, 2035 Pf Prism Cv
Inlyta US8791140

(Pediatric)

Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals Jun 14, 2031 Pf Prism Cv
Inlyta US8791140 Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals Dec 14, 2030 Pf Prism Cv
Inlyta US6534524

(Pediatric)

Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use Oct 29, 2025

(Expired)

Pf Prism Cv
Inlyta US6534524 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use Apr 29, 2025

(Expired)

Pf Prism Cv
Inlyta US7141581 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use Jun 30, 2020

(Expired)

Pf Prism Cv



Axitinib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Axitinib:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE1
Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial NRG Oncology NA RECRUITING
(Sep 1, 2026)
PHASE2
Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer Pfizer NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
MANTIS-RCC: Toripalimab-Axitinib Induction in TLS-Positive Advanced Non-Clear Cell and Renal Medullary Carcinomas Fudan University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma Stephanie Berg NA RECRUITING
(Aug 1, 2026)
PHASE2
TACTIC-RCC: Toripalimab Plus Axitinib Induction With Selective Deferred Cytoreductive Nephrectomy in TLS-Positive Advanced Clear Cell Renal Cell Carcinoma Fudan University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Molecularly Tailored Therapy in Advanced Pancreatic Cancer Herlev Hospital NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
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 Dana-Farber Cancer Institute NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Axitinib + Ipilimumab in Advanced Melanoma H. Lee Moffitt Cancer Center and Research Institute NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
A Trial of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma Peking University Cancer Hospital & Institute NA ENROLLING BY INVITATION
(Jul 1, 2026)
PHASE1
SABR Combined With Axitinib and Toripalimab for Oligometastatic Renal Cell Carcinoma Hebei Medical University Fourth Hospital NA RECRUITING
(Jul 1, 2026)
PHASE2
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Pfizer NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
A Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma Akeso NA COMPLETED
(Jun 1, 2026)
PHASE2
Radiopharmaceutical Treatment of Advanced Kidney Cancer European Organisation for Research and Treatment of Cancer - EORTC NA RECRUITING
(Jun 1, 2026)
PHASE2
Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer SWOG Cancer Research Network NA RECRUITING
(Jun 1, 2026)
PHASE3
Study to Evaluate the Efficacy of Zanzalintinib in the Treatment of Relapsed or Metastatic Adenoid Cystic Carcinomas of the Head and Neck UNICANCER NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer University of Southern California NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma Fox Chase Cancer Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1, PHASE2
A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer Jiangsu Alphamab Biopharmaceuticals Co., Ltd NA COMPLETED
(May 1, 2026)
PHASE2
A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors Incyte Corporation NA TERMINATED
(May 1, 2026)
PHASE1, PHASE2
Phase 2a Study to Evaluate the Efficacy and Safety of SCAI-005 Ophthalmic Solution in Subjects With Neovascular Age-related Macular Degeneration SCAI Therapeutics NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas Grupo Espanol de Tumores Neuroendocrinos NA COMPLETED
(Apr 1, 2026)
PHASE2, PHASE3
SLM + Axitinib for Clear Cell RCC Mohammed Milhem NA COMPLETED
(Apr 1, 2026)
PHASE1, PHASE2
A Study of Durvalumab in Combination With Doxorubicin for Advanced Soft Tissue Sarcoma Yonsei University NA COMPLETED
(Apr 1, 2026)
PHASE1, PHASE2
Axitinib Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractory Third Line Metastatic Colorectal Cancer Imperial College London NA COMPLETED
(Apr 1, 2026)
PHASE2
Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus University of Colorado, Denver NA RECRUITING
(Apr 1, 2026)
PHASE2
Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma ZHOU FANGJIAN NA RECRUITING
(Mar 1, 2026)
PHASE3
A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma Hao Zeng NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
Study of Adaptive Immunotherapy With VEGFR-TKI in Patients With Advanced RCC H. Lee Moffitt Cancer Center and Research Institute NA SUSPENDED
(Mar 1, 2026)
PHASE2
A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy Ocular Therapeutix, Inc. NA RECRUITING
(Mar 1, 2026)
PHASE3
An Open-label, Randomized Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of the Combination Therapy of SLC-3010 and Axitinib Compared to Axitinib Monotherapy as a Second-line Treatment for Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma Yonsei University NA RECRUITING
(Mar 1, 2026)
PHASE2
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 Ocular Therapeutix, Inc. NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE3


Axitinib Generic API Manufacturers

Several generic applications have been filed for Axitinib.

Given below is the list of companies who have filed for Axitinib generic, along with the locations of their manufacturing plants worldwide.