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THIOPLEX

NDA

THIOTEPA | N020058 | IMMUNEX CORP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

4 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from eVenus Pharmaceutical Laboratories Inc. FDA-2015-P-1503 · 3 docket documents eVenus Pharmaceutical Laboratories Inc. filed this citizen petition under 21 CFR §10.20 and §10.30 requesting that the FDA Commissioner designate a reference listed drug for Thiotepa Injection 15mg/vial in the Orange Book and Drugs@FDA to enable future sponsors to submit abbreviated new drug applica	Other	2015-05-12	Granted	eVenus Pharmaceutical Laboratories Inc.
Citizen Petition From Lachman Consulting Services, Inc. FDA-2014-P-2140 · 7 docket documents Lachman Consulting Services, Inc. filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Thiotepa for Injection at a 100 mg/vial strength is suitable for submission as an Abbreviated New Drug Application, based	Other	2014-12-09	Denied	Lachman Consulting Services, Inc.
Citizen Petition from Hyman Phelps & McNamara PC FDA-2014-P-1470 · 3 docket documents Hyman, Phelps & McNamara PC filed this citizen petition pursuant to Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA designate Thiotepa for Injection, 15 mg/vial, approved under ANDA No. 075547, as a Reference Listed Drug in the Orange Book to enable prospective ANDA	505(q)	2014-09-29	Withdrawn	Hyman Phelps & McNamara PC
Citizen Petition From Strides Inc. A Mylan Company FDA-2014-P-0169 · 3 docket documents Strides Inc., a Mylan company, filed this petition on January 29, 2014, requesting that the FDA declare Thiotepa for Injection USP 15mg/vial suitable for submission as an abbreviated new drug application (ANDA) under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act. The petitioner see	Other	2014-02-18	Withdrawn	Strides Inc. A Mylan Company

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

193 trials from ClinicalTrials.gov — 12 recruiting, 14 active, 107 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant NCT02061800	Phase 1/2	Active	Diane George	14	2013-06-03 → 2026-07
TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies NCT03849651	Phase 2	Active	St. Jude Children's Research Hospital	69	2019-01-31 → 2026-06-07
A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT NCT04217278	Phase 2/3	Active	University of Birmingham	333	2020-01-27 → 2026-05
Haplocompatible Transplant Using TCRα/β Depletion Followed by CD45RA-Depleted Donor Lymphocyte Infusions for Severe Combined Immunodeficiency (SCID)NCT03597594	Phase 1/2	Active	St. Jude Children's Research Hospital	4	2021-09-02 → 2028-07-01
HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors NCT02875314	Phase 4	Active	Parth Patel	250	2015-09 → 2030-12
Immune Disorder HSCT Protocol NCT01821781	Phase 2	Active	Washington University School of Medicine	20	2013-04-29 → 2026-04
Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated (RB SFCE 2009)NCT02870907	Phase 2	Active	Institut Curie	195	2010-03-18 → 2031-03-01
Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes NCT03399773	Phase 2	Active	Fred Hutchinson Cancer Center	31	2022-05-10 → 2027-04-02
Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma NCT01511562	Phase 2	Active	Alliance for Clinical Trials in Oncology	113	2012-09 → 2027-05-02
Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant NCT02861417	Phase 2	Active	M.D. Anderson Cancer Center	204	2016-08-05 → 2026-08-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain7 active DMFs6 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

HERAEUS PRECIOUS METALS GMBH AND CO KGTHIOTEPA USP

DMF 139111998

IDT AUSTRALIA LTDTHIOTEPA USP

DMF 141701999

MSN LABORATORIES PRIVATE LTDTHIOTEPA USP [ROUTE CODE "ZT"]

DMF 304242016

NATCO PHARMA LTDTHIOTEPA

DMF 311042017

EMCURE PHARMACEUTICALS LTDTHIOTEPA USP

DMF 327462018

INDENA SPATHIOTEPA

DMF 330372019

SEACROSS PHARMA USA INCTHIOTEPA

DMF 384062023

SUMIKA FINE CHEMICALS CO LTDInactiveTHIOTEPA USP XX

DMF 53961984

SOGO PHARMACEUTICAL CO LTDInactiveTHIOTEPA

DMF 75181988

ICI COLOURS AND FINE CHEMSInactiveTHIOTEPA

DMF 82281989

JIANGSU HENGRUI MEDICINE CO LTDInactiveTHIOTEPA USP NON STERILE BULK DRUG

DMF 143161999

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveTHIOTEPA

DMF 145121999

MYLAN LABORATORIES LTDInactiveTHIOTEPA USP

DMF 263832012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 22, 1994

No patent or exclusivity listings for this strength.