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VASOTEC

NDA

ENALAPRILAT | N019309 | BIOVAIL LABORATORIES INTERNATIONAL SRL

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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs2 inactive

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

HIKMA PHARMACEUTICALS LLCENALAPRILAT USP

DMF 198092006

DR REDDYS LABORATORIES LTDENALAPRILAT USP

DMF 360392021

ESTEVE QUIMICA SAInactiveENALAPRILAT

DMF 127111997

EXCELLA GMBHInactiveENALAPRILAT

DMF 139041998

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 29, 2004	SUPPL -23	View Letter (PDF)
Oct 30, 2002	SUPPL -25	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 9, 1988

No patent or exclusivity listings for this strength.