Tolak Patent Expiration

Tolak is a drug owned by Hill Dermaceuticals Inc. It is protected by 1 US drug patent filed in 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 18, 2023. Details of Tolak's patents and their expiration are given in the table below.

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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7169401 Topical skin care composition containing refined peanut oil
Jul, 2023

(3 years ago)

Expired


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 Tolak's patents.

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

Activity Date Patent Number
Patent litigations
Mail-Record Petition Decision of Granted to Make Entity Status large 29 Aug, 2019 US7169401
Mail O.P. Petition Decision 29 Aug, 2019 US7169401
Record Petition Decision of Granted to Make Entity Status large 28 Aug, 2019 US7169401
O.P. Petition Decision 28 Aug, 2019 US7169401
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 28 Aug, 2019 US7169401
Petition Entered 30 Jan, 2019 US7169401
Payment of Maintenance Fee under 1.28(c) 30 Jan, 2019 US7169401
Refund - Payment of Maintenance Fee under 1.28(c) 30 Jan, 2019 US7169401
Payment of Maintenance Fee, 12th Yr, Small Entity 26 Jul, 2018 US7169401
Notice of Final Determination- Ineligible 02 Mar, 2017 US7169401


FDA has granted several exclusivities to Tolak. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tolak, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Tolak.

Exclusivity Information

Tolak holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Tolak's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Sep 18, 2018

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US patents provide insights into the exclusivity only within the United States, but Tolak is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Tolak's family patents as well as insights into ongoing legal events on those patents.

Tolak's Family Patents

Tolak has patent protection in a total of 3 countries. It has a significant patent presence in the US with 71.4% of its patents being US patents. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Tolak.

Family Patents

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Clinical Trials

Recent Clinical Trials on Tolak:

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
Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer Alliance for Clinical Trials in Oncology NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma Columbia University NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) Hoffmann-La Roche NA RECRUITING
(Sep 1, 2026)
PHASE1
GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites Kyushu University NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma Alliance for Clinical Trials in Oncology NA RECRUITING
(Sep 1, 2026)
PHASE3
Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer University of Wisconsin, Madison NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC Genentech, Inc. NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation Amgen NA RECRUITING
(Sep 1, 2026)
PHASE3
Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors Revolution Medicines, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer National Cancer Institute (NCI) NA RECRUITING
(Sep 1, 2026)
PHASE1
Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer AbbVie NA RECRUITING
(Sep 1, 2026)
PHASE2
NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial Roswell Park Cancer Institute NA RECRUITING
(Sep 1, 2026)
PHASE2
A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors MediLink Therapeutics (Suzhou) Co., Ltd. NA RECRUITING
(Sep 1, 2026)
PHASE1
9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY) Anwaar Saeed NA RECRUITING
(Sep 1, 2026)
PHASE1
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE3
BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + Surgery/SBRT for BCLC-C HCC With PVTT and/or Oligometastases Shandong Cancer Hospital and Institute NA RECRUITING
(Sep 1, 2026)
PHASE2
Utility of ctDNA in Early Switch of First-line Chemotherapy in Metastatic Pancreatic Ductal Adenocarcinoma University of Miami NA RECRUITING
(Sep 1, 2026)
PHASE2
Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer Case Comprehensive Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE2
Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer Summit Therapeutics NA RECRUITING
(Sep 1, 2026)
PHASE3
Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors H. Lee Moffitt Cancer Center and Research Institute NA RECRUITING
(Sep 1, 2026)
PHASE1
A Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal Cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. NA RECRUITING
(Sep 1, 2026)
PHASE3
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1) Genmab NA RECRUITING
(Sep 1, 2026)
PHASE3
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2) Genmab NA RECRUITING
(Sep 1, 2026)
PHASE3
Iparomlimab and Tuvonralimab With Lenvatinib, Radiotherapy, and HAIC for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus Union Hospital, Tongji Medical College, Huazhong University of Science and Technology NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based Systemic Chemotherapy MediLink Therapeutics (Suzhou) Co., Ltd. NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
A Study of Olomorasib (LY3537982) in Participants With Advanced Colorectal Cancer and a KRAS G12C Mutation Eli Lilly and Company NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02) Fudan University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Clinical Study of Radiotherapy Combined With Adebrelimab and NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC MedImmune LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers SWOG Cancer Research Network NA RECRUITING
(Aug 1, 2026)
PHASE2
Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group Goethe University NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Adaptive Approach to Neoadjuvant Therapy to Maximize Resection Rates for Pancreatic Adenocarcinoma University of Cincinnati NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids Beth Israel Deaconess Medical Center NA COMPLETED
(Aug 1, 2026)
PHASE2
Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer Baylor College of Medicine NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer Janssen Research & Development, LLC NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer City of Hope Medical Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors Shanghai Junshi Bioscience Co., Ltd. NA COMPLETED
(Aug 1, 2026)
PHASE1, PHASE2
HAIC, Lenvatinib, and Cadonilimab as Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma Tongji Hospital NA RECRUITING
(Aug 1, 2026)
PHASE2
Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV Emory University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer Arjun Mittra NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer Janssen Research & Development, LLC NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy Janssen Research & Development, LLC NA RECRUITING
(Aug 1, 2026)
PHASE3
Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT Second Affiliated Hospital of Guangzhou Medical University NA RECRUITING
(Aug 1, 2026)
PHASE2
Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA Massachusetts General Hospital NA RECRUITING
(Aug 1, 2026)
PHASE2
Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma Roswell Park Cancer Institute NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial City of Hope Medical Center NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE2
Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment of Microsatellite Stable Advanced/Metastatic Colorectal Cancer City of Hope Medical Center NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer Multitude Therapeutics Inc. NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma AbbVie NA RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya UNC Lineberger Comprehensive Cancer Center NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan Sichuan Baili Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
NCT + PD1 + Ketogenic Diet and/or Vitamin C for LARC Sixth Affiliated Hospital, Sun Yat-sen University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Anlotinib + Benmelstobart + HAIC in Unresectable HCC: A Phase II Study Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University NA RECRUITING
(Aug 1, 2026)
PHASE2
mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer Sixth Affiliated Hospital, Sun Yat-sen University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer National Cancer Institute (NCI) NA COMPLETED
(Jul 1, 2026)
PHASE3
Study of SIB-IMRT in Combination With 5-FU and Mitomycin-C Among Patients With Locally Advanced Anal Canal Cancer: Efficacy, Safety and Quality of Life Centre Francois Baclesse NA COMPLETED
(Jul 1, 2026)
PHASE2
Biweekly Versus Triweekly Raltitrexed With Oxaliplatin (With or Without Bevacizumab) in First-line Metastatic Colorectal Cancer Centre Hospitalier Universitaire de Besancon NA COMPLETED
(Jul 1, 2026)
PHASE2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors Merus B.V. NA RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Phase I/II Study of Perioperative Chemotherapy Plus Immunotherapy Followed by Surgery in Localized Esophageal and Gastroesophageal Adenocarcinoma M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread ECOG-ACRIN Cancer Research Group NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10) Mirati Therapeutics Inc. NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Short-course Radiotherapy Followed by Consolidation Chemotherapy. 2021-001206-29 Gruppo Oncologico del Nord-Ovest NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma AbbVie NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
A Clinical Trial to Evaluate the Safety, Tolerability and Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies Providence Health & Services NA RECRUITING
(Jul 1, 2026)
PHASE1
Study Evaluating Two Treatment Strategies for Rectal Cancer in Patients ≥75 Years Old UNICANCER NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation Genfleet Therapeutics (Shanghai) Inc. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
DCE-MRI for Neoadjuvant Treatment Assessment in Patients With Borderline Resectable Pancreatic Cancer Ohio State University Comprehensive Cancer Center NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
FOLFIRI Plus Bevacizuamb and QL1706 in Second-Line Treatment for mCRC Sun Yat-sen University NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
Efficacy and Safety of Serplulimab in Combination With Bevacizumab and FOLFIRINOX or NALIRIFOX as Second-Line Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Shanghai General Hospital, China NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Protective Role of Alpha-Lipoic Acid in Chemotherapy-Induced Mucositis Ain Shams University NA RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
SMAD4 Tailored Neoadjuvant Therapy for the Treatment of Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma, SMART-PANC Trial Northwestern University NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer CSPC Megalith Biopharmaceutical Co.,Ltd. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer University of Rochester NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma University of Wisconsin, Madison NA RECRUITING
(Jun 1, 2026)
PHASE2
Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC University of Wisconsin, Madison NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer XBiotech, Inc. NA COMPLETED
(Jun 1, 2026)
PHASE1, PHASE2
Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis Mayo Clinic NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1
Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS Mutation Cardiff Oncology NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer H. Lee Moffitt Cancer Center and Research Institute NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Optimizing Ocular Outcomes: A Dual-armed Study for Periorbital Burn Management Virginia Commonwealth University NA WITHDRAWN
(Jun 1, 2026)
PHASE1
Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advanced or Metastatic Pancreatic Cancer Mayo Clinic NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
IMMUNORARE5: A National Platform of 5 Academic Phase II Trials Coordinated by Lyon University Hospital to Assess the Safety and the Efficacy of the IMMUNOtherapy With Domvanalimab + Zimberelimab Combination in Patients With Advanced RARE Cancers Hospices Civils de Lyon NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
A Study of PHST001 in Advanced Solid Tumors Pheast Therapeutics NA RECRUITING
(Jun 1, 2026)
PHASE1
Efficacy and Safety of Trifluridine/Tipiracil (TAS-102) Combined With Bevacizumab and Serplulimab in Patients With Metastatic Colorectal Cancer Undergoing Cytoreductive Surgery: A Single-Arm, Single-Center Clinical Study Second Affiliated Hospital, School of Medicine, Zhejiang University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE1
A Clinical Study of Arfolitixorin in Patients With mCRC Isofol Medical AB NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity ECOG-ACRIN Cancer Research Group NA RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL) SCRI Development Innovations, LLC NA RECRUITING
(Jun 1, 2026)
PHASE2
Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer Genfleet Therapeutics (Shanghai) Inc. NA RECRUITING
(Jun 1, 2026)
PHASE3
EMB-01 in Combination With Chemotherapy for Unresectable or Metastatic Colorectal Cancer Shanghai EpimAb Biotherapeutics Co., Ltd. NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE1
Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer National Cancer Institute (NCI) NA COMPLETED
(May 1, 2026)
PHASE3
FOLFOXIRI With or Without Bevacizumab as First-line Treatment for Unresectable Liver-only Metastatic Colorectal Cancer Patients With RAS Mutation-type Sun Yat-sen University NA COMPLETED
(May 1, 2026)
PHASE2
A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors MedImmune LLC NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1, PHASE2
FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer National Cancer Institute (NCI) NA COMPLETED
(May 1, 2026)
PHASE2
Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer University of Nebraska NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Epidermal Growth Factor Receptor (EGFR) Antagonist Chimeric Anti-EGFR Monoclonal Antibody Trial Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. NA TERMINATED
(May 1, 2026)
PHASE3
Bevacizumab Plus mFOLFOXIRI as First-line Treatment for Patients With Unresectable Metastatic Colorectal Cancer Yanhong Deng NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer Virginia Commonwealth University NA RECRUITING
(May 1, 2026)
PHASE2
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer Erasmus Medical Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression Amgen NA COMPLETED
(May 1, 2026)
PHASE3
A Study of VS-6766 and Cetuximab in Patients With Advanced Colorectal Cancer University of Chicago NA SUSPENDED
(May 1, 2026)
PHASE1, PHASE2
Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC) Ciusss de L'Est de l'Île de Montréal NA RECRUITING
(May 1, 2026)
PHASE2
Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas Institut de Recherches Internationales Servier NA COMPLETED
(May 1, 2026)
PHASE2
Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations SWOG Cancer Research Network NA RECRUITING
(May 1, 2026)
PHASE3
Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer Shandong Cancer Hospital and Institute NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression Sixth Affiliated Hospital, Sun Yat-sen University NA RECRUITING
(May 1, 2026)
PHASE2
Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus First Hospital of China Medical University NA RECRUITING
(May 1, 2026)
PHASE2
Comparing Efficacy and Safety of Enlituo® Versus Erbitux® Plus FOLFOX in Locally Advanced/Metastatic Colorectal Cancer With RAS/BRAF Wild-type and MSS/pMMR Status. Taizhou Mabtech Pharmaceutical Co.,Ltd NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma Suzhou Zelgen Biopharmaceuticals Co.,Ltd NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study Genentech, Inc. NA COMPLETED
(Apr 1, 2026)
PHASE2
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. Astellas Pharma Global Development, Inc. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE3
A Trial to Evaluate Safety, Tolerability, and Preliminary Efficacy of Misetionamide (GP-2250) as Monotherapy or in Combination With Gemcitabine Persevere Therapeutics Inc. NA RECRUITING
(Apr 1, 2026)
PHASE1
A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment Ipsen NA COMPLETED
(Apr 1, 2026)
PHASE3
Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients Institut du Cancer de Montpellier - Val d'Aurelle NA RECRUITING
(Apr 1, 2026)
PHASE2
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies Arcus Biosciences, Inc. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Clinical Efficacy of QYHJ and Standard Chemotherapy in the Treatment of Advanced Pancreatic Cancer Fudan University NA COMPLETED
(Apr 1, 2026)
PHASE3
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers Arcus Biosciences, Inc. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
Total Neoadjuvant Therapy in Rectal Cancer National Cheng-Kung University Hospital NA RECRUITING
(Apr 1, 2026)
PHASE2
Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients Sun Yat-sen University NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Sintilimab Plus FOLFIRI as Second-line Therapy for Patients With HER2-negative Advanced Gastric Cancer Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation Tyligand Pharmaceuticals (Suzhou) Limited NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel UNC Lineberger Comprehensive Cancer Center NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer(SPARKLE) Sixth Affiliated Hospital, Sun Yat-sen University NA RECRUITING
(Apr 1, 2026)
PHASE2
Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer The Methodist Hospital Research Institute NA RECRUITING
(Apr 1, 2026)
PHASE1
Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND) Shandong Cancer Hospital and Institute NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer The Methodist Hospital Research Institute NA RECRUITING
(Apr 1, 2026)
PHASE2
A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors Suzhou Suncadia Biopharmaceuticals Co., Ltd. NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases UNICANCER NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM Jun Huang NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Sequential FOLFOX-HAIC-TACE Plus Sintilimab-Bevacizumab Neoadjuvant Therapy Versus Direct Resection in Resectable High-Risk Recurrence Hepatocellular Carcinoma BinYong Liang NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal Cancer Shanghai Henlius Biotech NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE1
Efficacy and Safety of Low-dose Bevacizumab Plus Adebrelimab Combined With Transarterial Chemoembolization Followed by Hepatic Arterial Infusion Chemotherapy (TACE-HAIC) as First-line Treatment for Unresectable Hepatocellular Carcinoma: A Single-arm Phase 2 Trial Third Affiliated Hospital, Sun Yat-Sen University NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
TAIC FOLFOX for Locally Advanced G/GEJA Guang'anmen Hospital of China Academy of Chinese Medical Sciences NA RECRUITING
(Apr 1, 2026)
PHASE2
Efficacy and Tolerance Evaluation in FOLFIRINOX Dose Adjusted in Elderly Patients With a Metastatic Pancreatic Cancer Institut Cancerologie de l'Ouest NA COMPLETED
(Mar 1, 2026)
PHASE2
Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers Novartis Pharmaceuticals NA COMPLETED
(Mar 1, 2026)
PHASE1
Platform Trial Evaluating Treatment of Neoadjuvant Trastuzumab-deruxtecan Containing Combination Therapies for HER2+, Resectable Esophagogastric Adenocarcinoma Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma Sun Yat-sen University NA RECRUITING
(Mar 1, 2026)
PHASE2
Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma UNICANCER NA RECRUITING
(Mar 1, 2026)
PHASE2
The Application of Intralesional 5-fluorouracil for the Management of Hypertrophic Facial Scars in the Periocular Region Resulting From Trauma and Surgical Procedures in Individuals Aged Over 18 Years Instituto de Oftalmología Fundación Conde de Valenciana NA RECRUITING
(Mar 1, 2026)
PHASE4




Generic Launch

Generic Release Date:

Tolak's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 18, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Tolak Generic API suppliers:

Fluorouracil is the generic name for the brand Tolak. 23 different companies have already filed for the generic of Tolak, with Fresenius Kabi Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tolak's generic

Alternative Brands for Tolak

There are several other brand drugs using the same active ingredient (Fluorouracil) as Tolak. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Extrovis
Carac


Apart from brand drugs containing the same ingredient, some generics have also been filed for Fluorouracil, Tolak's active ingredient. Check the complete list of approved generic manufacturers for Tolak





About Tolak

Tolak is a drug owned by Hill Dermaceuticals Inc. Tolak uses Fluorouracil as an active ingredient. Tolak was launched by Hill Dermaceuticals in 2015.

Approval Date:

Tolak was approved by FDA for market use on 18 September, 2015.

Active Ingredient:

Tolak uses Fluorouracil as the active ingredient. Check out other Drugs and Companies using Fluorouracil ingredient

Dosage:

Tolak is available in cream form for topical use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
4% CREAM Prescription TOPICAL