Viewing data from:

TEPYLUTE

NDA

THIOTEPA | N216984 | SHORLA PHARMA LTD

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

11975013

Aug. 16, 2041

12622921

Aug. 16, 2041

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

No FDA citizen petitions matched from Regulations.gov

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.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$424.89

Highest Price

$3299.02

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
81927-0105-01TEPYLUTE 10MG/ML INJ,SOLN	$424.89	FSS	Shorla Oncology	08/14/2029
81927-0106-01TEPYLUTE 10MG/ML INJ,SOLN	$3299.02	FSS	Shorla Oncology	08/14/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jan 23, 2026	SUPPL -5	View Letter (PDF)
Feb 27, 2025	SUPPL -1	View Letter (PDF)
Jun 26, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 15MG/1.5ML (10MG/ML)

RLD

2 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 25, 2024

Patents (2) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11975013	Aug 16, 2041	—	—	Yes	—	—
12622921	Aug 16, 2041	—	—	—		—

#002 — 100MG/10ML (10MG/ML)

RLD

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 26, 2025