Pemetrexed Patent Expiration

Pemetrexed was first introduced by Eagle Pharmaceuticals Inc in its drug Pemfexy on Feb 8, 2020. Another drug containing Pemetrexed is Pemetrexed. 2 different companies have introduced drugs containing Pemetrexed.


Pemetrexed Patents

Given below is the list of patents protecting Pemetrexed, 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
Pemfexy US11793813 Pemetrexed formulations Feb 19, 2036 Eagle Pharms
Pemfexy US12115164 Pemetrexed Formulations Feb 19, 2036 Eagle Pharms
Pemfexy US9604990 Crystalline forms of pemetrexed diacid and manufacturing processes therefor Oct 28, 2035 Eagle Pharms
Pemfexy US7772209 Antifolate combination therapies May 24, 2022

(Expired)

Eagle Pharms



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 Pemetrexed's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 27 Jan, 2025 US11147817
Patent Issue Date Used in PTA Calculation 19 Oct, 2021 US11147817
Recordation of Patent Grant Mailed 19 Oct, 2021 US11147817
Email Notification 30 Sep, 2021 US11147817
Issue Notification Mailed 29 Sep, 2021 US11147817
Application Is Considered Ready for Issue 22 Sep, 2021 US11147817
Dispatch to FDC 22 Sep, 2021 US11147817
Issue Fee Payment Verified 20 Sep, 2021 US11147817
Issue Fee Payment Received 20 Sep, 2021 US11147817
Electronic Review 01 Jul, 2021 US11147817


Pemetrexed's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Pemetrexed:

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 Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE3
Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01) Bristol-Myers Squibb NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE2
Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth Factor Receptor Mutations Latin American Cooperative Oncology Group NA COMPLETED
(Aug 1, 2026)
PHASE2
A Phase 2 Study to Evaluate the Triplet Combination of Pemetrexed Plus AB928 (Etrumadenant) + AB122 (Zimberelimab) in Patients With Previously Treated Advanced or Metastatic MTAP Deficient Urothelial Carcinoma M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
High-dose Furmonertinib Combined With Bevacizumab and Intrathecal Pemetrexed Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Meningeal Metastasis Sun Yat-sen University NA COMPLETED
(Aug 1, 2026)
PHASE2
Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis Guangzhou Medical University NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Intrathecal Dual Checkpoint Inhibitor (PD-1 and CTLA-4) in Combination With Pemetrexed for Leptomeningeal Metastasis Guangzhou Medical University NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma MedImmune LLC NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM Biotheus Inc. NA COMPLETED
(Jun 1, 2026)
PHASE2
A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer AbbVie NA RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Phase II Study of Upfront SRT Plus Ivonescimab/Chemotherapy vs Ivonescimab/Chemotherapy in NSCLC Brain Mets European Organisation for Research and Treatment of Cancer - EORTC NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
MC200708 Pemetrexed and Pembrolizumab for the Treatment of Recurrent and/or Metastatic Salivary Gland Cancer Mayo Clinic NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification Hutchison Medipharma Limited NA COMPLETED
(May 1, 2026)
PHASE3
A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Immune Checkpoint Inhibitors Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC West China Hospital NA RECRUITING
(May 1, 2026)
PHASE2
Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure:Phase I/II Sichuan University NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer Sichuan University NA RECRUITING
(May 1, 2026)
PHASE1
Immune Checkpoint Inhibitor Combined With Pemetrexed Intrathecal Injection for Leptomeningeal Metastasis From Solid Tumors Guangzhou Medical University NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Relapsed or Refractory Primary Diffuse Large B-cell Lymphoma (DLBCL) of the Central Nervous System (CNS) Seoul National University Hospital NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Zorifertinib Plus Intra-Ommaya CSF Chemotherapy for Leptomeningeal Progression in NSCLC After Third-Generation EGFR-TKI Cancer Institute and Hospital, Chinese Academy of Medical Sciences NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer Genfleet Therapeutics (Shanghai) Inc. NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC Taipei Veterans General Hospital, Taiwan NA RECRUITING
(Mar 1, 2026)
PHASE2


Pemetrexed Generic API Manufacturers

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