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URACIL MUSTARD

NDA

URACIL MUSTARD | N012892 | SHIRE DEVELOPMENT INC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)NCT06966700	Phase 3	Recruiting	Merck Sharp & Dohme LLC	2,400	2025-06-30 → 2034-12-29

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

API Supply Chain0 active DMFs3 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ASAHI KASEI FINECHEM CO LTDInactiveURACIL

DMF 99081992

KYOWA HAKKO KOGYO CO LTDInactiveURACIL

DMF 100841992

SHANGHAI TAI HENG INDUSTRY CO LTDInactiveURACIL

DMF 188322005

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 4, 2012	SUPPL -15	View Letter (PDF)
Oct 4, 2012	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.