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

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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

No clinical trials found on ClinicalTrials.gov for this drug

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)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11975013	Aug 16, 2041	—	—	Yes	—	—
12622921	Aug 16, 2041	—	—	—	U-4530	—

#002 — 100MG/10ML (10MG/ML)

RLD

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 26, 2025

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

SHORLA added U.S. Patent 12,622,921 to the Orange Book for TEPYLUTE (thiotepa) NDA 216984, listed as a product-specific patent for the approved formulation.

New: New record

ADDED7/1/2026

Shorla added patent 12622921 to the Orange Book listing for Tepylute (thiotepa) NDA 216984.

New: New record