Belzutifan Patent Expiration

Belzutifan is Used for treating advanced renal cell carcinoma after previous treatment with specific inhibitors. It was first introduced by Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc in its drug Welireg on Aug 13, 2021.


Belzutifan Patents

Given below is the list of patents protecting Belzutifan, 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
Welireg US12358870 Solid Dispersions And Pharmaceutical Compositions Comprising A Substituted Indane And Methods For The Preparation And Use Thereof Jun 30, 2042 Merck Sharp Dohme
Welireg US10335388 Combination Therapy Of A Hif-2-Alpha Inhibitor And An Immunotherapeutic Agent And Uses Thereof Apr 14, 2036 Merck Sharp Dohme
Welireg US9908845 Aryl ethers and uses thereof Sep 05, 2034 Merck Sharp Dohme
Welireg US9969689 Aryl ethers and uses thereof Sep 05, 2034 Merck Sharp Dohme
Welireg USRE49948 Aryl ethers and uses thereof Sep 05, 2034 Merck Sharp Dohme



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Belzutifan's patents.

Given below is the list recent legal activities going on the following patents of Belzutifan.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 14 Aug, 2025 US9908845
transaction for FDA Determination of Regulatory Review Period 30 Jan, 2024 US9969689
transaction for FDA Determination of Regulatory Review Period 30 Jan, 2024 US9908845
transaction for FDA Determination of Regulatory Review Period 11 Dec, 2023 US9908845
transaction for FDA Determination of Regulatory Review Period 11 Dec, 2023 US9969689
Second letter to regulating agency to determine regulatory review period 30 May, 2023 US9908845
Second letter to regulating agency to determine regulatory review period 30 May, 2023 US9969689
Letter from FDA or Dept of Agriculture re PTE application 13 Sep, 2022 US9969689
Letter from FDA or Dept of Agriculture re PTE application 13 Sep, 2022 US9908845
Patent Term Extension (156) Dismissed 12 Jan, 2022 US9969689


Belzutifan's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Belzutifan:

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
A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001) Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013) Merck Sharp & Dohme LLC NA COMPLETED
(Sep 1, 2026)
PHASE2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE2
Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE3
A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study of Belzutifan in Adolescent Participants With Solid Tumors (MK-9999-01E/LIGHTBEAM-U01) Merck Sharp & Dohme LLC NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
Neoadjuvant Belzutifan Plus Pembrolizumab in High-Risk, Locally Advanced Clear Cell Renal Cell Carcinoma Peter MacCallum Cancer Centre, Australia NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE) M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE2
A Clinical Trial of MK-2010 Alone and With Other Treatments in Participants With Advanced Solid Tumors (MK-2010-002) Merck Sharp & Dohme LLC NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Effects of Belzutifan on 89Zr-DFO-girentuximab PET Uptake in Patients With Renal Cell Carcinoma (RCC) NYU Langone Health NA RECRUITING
(Jul 1, 2026)
PHASE1
A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033) Merck Sharp & Dohme LLC NA RECRUITING
(Jul 1, 2026)
PHASE3
TROP2 CAREngineered Cord Blood-Derived NK Cells + Belzutifan In Pancreatic Cancer M.D. Anderson Cancer Center NA SUSPENDED
(Jul 1, 2026)
PHASE1, PHASE2
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
A Study of Belzutifan (MK-6482) in Participants With Advanced Clear Cell Renal Cell Carcinoma (MK-6482-018) Merck Sharp & Dohme LLC NA COMPLETED
(May 1, 2026)
PHASE1
A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Belzutifan's Role in Active Surveillance Versus Treatment for Indolentmetastatic Clear Cell Renal Ccell Carcinoma (BRAVE-RCC) M.D. Anderson Cancer Center NA RECRUITING
(May 1, 2026)
PHASE2
A Phase 2 Study of Belzutifan (PT2977, MK-6482) for the Treatment of Von Hippel Lindau (VHL) Disease-Associated Renal Cell Carcinoma (RCC) (MK-6482-004) Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE3


Belzutifan Generic API Manufacturers

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