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Data updated: May 26, 2026

OTREXUP PFS (methotrexate)

Oncology Approved 2013-10-11
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
12
Years on Market

Details

Status
Discontinued
First Approved
2013-10-11
Patent Cliff
2031

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SUBCUTANEOUS
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ASSERTIO SPECLTY
Active Ingredient: METHOTREXATE

OTREXUP PFS Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
66 FDA actions from 2013 to 2019 · 1 indication expansions
Dec 2019 SUPPL
Label · Labeling
FDA Letter Label
Jun 2019 SUPPL
Label · Labeling
FDA Letter Label
Mar 2018 SUPPL
Label · Labeling
FDA Letter Label

What OTREXUP PFS Treats

1 FDA approvals

Originally approved for its first indication in 2013 .

  • Other (1)
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Clinical Trial Registry

517 trials
Trial Sponsor ID Phase Status Title
NCT04530565 NCI-2020-06381 NCI-2020-06381, EA9181 Ph 3 active not recruiting Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
NCT04628767 NCI-2020-09850 NCI-2020-09850, EA8192 Ph 2, Ph 3 recruiting Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
NCT06124157 NCI-2023-09214 NCI-2023-09214, AALL2131 Ph 2 recruiting A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
NCT05691478 NCI-2022-08567 NCI-2022-08567, AOST2032 Ph 2, Ph 3 recruiting A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
NCT03808610 2016-0629 NCI-2018-03360, 2016-0629 Ph 1, Ph 2 terminated Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia
NCT06317662 NCI-2024-01994 NCI-2024-01994, AALL2321 Ph 2 recruiting Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia
NCT03286634 ASIA-DS-ALL-2016 Ph 2 active not recruiting ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016
NCT06997068 MC240701 24-009083 Ph 2 recruiting Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Head and Neck Cancer in a Rural Midwest United States Population
NCT03150693 A041501 NCI-2016-01981, U10CA180821 Ph 3 recruiting Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia
NCT04609046 NCI-2020-08331 NCI-2020-08331, A051901 Ph 1 recruiting Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma
NCT07446400 359-201-00015 Ph 1 recruiting A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
NCT04872790 STUDY00022691 NCI-2021-01791, STUDY00022691 Ph 1 active not recruiting Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia
NCT04043494 LBL 2018 UKM17_0023 2017-001691-39 Ph 3 recruiting International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
NCT07498465 PEPN2513 NCI-2026-01768, PEPN2513 Ph 1 withdrawn A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia
NCT04293562 AAML1831 NCI-2020-00546, AAML1831 Ph 3 recruiting A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
NCT07432815 MS-98-2025 Ph 4 recruiting Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant
NCT03593759 CHASM-CS-RCT UOttawaHI Ph 3 recruiting Cardiac Sarcoidosis Randomized Trial
NCT03959085 AALL1732 NCI-2019-02845, AALL1732 Ph 3 recruiting Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
NCT02112916 results posted NCI-2014-00712 NCI-2014-00712, s14-01925 Ph 3 active not recruiting Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
NCT06231745 314879 Ph 3 completed Paroxetine Safety and Efficacy in Rheumatoid Arthritis
NCT02101853 results posted NCI-2014-00631 NCI-2014-00631, s15-00970 Ph 3 active not recruiting Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
NCT03914625 NCI-2019-02187 NCI-2019-02187, AALL1731 Ph 3 active not recruiting A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
NCT02883049 results posted NCI-2011-03797 NCI-2011-03797, S12-01254 Ph 3 active not recruiting Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
NCT02981628 AALL1621 NCI-2016-01494, AALL1621 Ph 2 recruiting Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
NCT07388498 20230219 Ph 3 recruiting A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
NCT06177067 RAVAML NCI-2023-10509 Ph 1 recruiting Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
NCT03007147 AALL1631 NCI-2016-01588, AALL1631 Ph 3 active not recruiting Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT02003222 results posted NCI-2013-02229 NCI-2013-02229, ECOG-E1910 Ph 3 active not recruiting Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia
NCT06289673 INITIALL NCI-2024-01659 Ph 4 recruiting Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
NCT06390319 SJALL23T NCI-2024-03015 Ph 2 recruiting Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)
NCT06533748 SJALL23H NCI-2024-06013 Ph 2 recruiting Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
NCT03206671 B-NHL 2013 UKM12_0020 2013-003253-21 Ph 3 active not recruiting Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents
NCT03964090 190103 19-C-0103 Ph 2 active not recruiting Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)
NCT00558519 results posted CALGB-10403 CALGB-10403, ECOG C10403 Ph 2 completed Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT04898894 SELCLAX NCI-2021-03435 Ph 1 active not recruiting Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
NCT02203526 140157 14-C-0157 Ph 1 active not recruiting Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma
NCT07176390 7240-014 U1111-1320-8718, 2025-521745-25-00 Ph 2 recruiting A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)
NCT04960579 MM P-BCMA-ALLO1-001 XO44788 Ph 1 active not recruiting P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
NCT05645718 2022-0312 NCI-2022-10168 Ph 2 recruiting Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia
NCT06960577 D933RC00002 Ph 3 recruiting Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
NCT07543640 MS-506-2024 Ph 2 not yet recruiting EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.
NCT05761171 AALL2121 NCI-2023-00503, AALL2121 Ph 2 active not recruiting A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia
NCT05848687 IRB-68271 PEDSHEMALL0015, NCI-2023-04129 Ph 1, Ph 2 recruiting TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
NCT05519579 NSH 1354 Ph 2 recruiting Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
NCT06247787 PEPN2312 NCI-2023-11026, PEPN2312 Ph 1 recruiting A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy
NCT07361133 MO 2504-505-120-198 Ph 2 not yet recruiting Cyclophosphamide and Etoposide as a Metronomic Therapy in Advanced Head and Neck Squamous Cell Cancer
NCT01424982 2011-0030 NCI-2011-02941, 2011-0030 Ph 2 active not recruiting Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia
NCT04384692 RG1006507 NCI-2020-01626, 10093 Ph 2 active not recruiting Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis
NCT05998642 I244 Ph 2 recruiting Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
NCT04216524 2019-0587 NCI-2019-08358, 2019-0587 Ph 2 recruiting Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

Showing 50 of 517 trials

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Key Completed Trials

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

OTREXUP PFS FDA Label Details

View full patent landscape →
15 OB patents · 3 families · 102 international docs across 15 countries

OTREXUP PFS Patents & Exclusivity

Latest Patent: May 2031

Patents (15 active)

US8814834 Expires May 27, 2031
US8480631 Expires Mar 19, 2030
US8579865 Expires Mar 19, 2030
US8945063 Expires Mar 19, 2030
US9421333 Expires Mar 19, 2030
US11497753 Expires Mar 19, 2030
US12357642 Expires Mar 19, 2030
US10709844 Expires Mar 10, 2029
US11684723 Expires Mar 10, 2029
US9867949 Expires Mar 10, 2029
US8021335 Expires Oct 4, 2026
US9629959 Expires Jan 24, 2026
US8562564 Expires Jan 24, 2026
US9533102 Expires Jan 24, 2026
US11446441 Expires Jan 24, 2026
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2031
  • • 720 active patents

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Data Sources

FDA Approval: NDA204824 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.