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AGGRASTAT

NDA

TIROFIBAN HYDROCHLORIDE | N020912 | MEDICURE INTERNATIONAL INC

2 strengths0 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 Chain3 active DMFs1 inactive

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

GLAND PHARMA LTDTIROFIBAN HYDROCHLORIDE

DMF 231732009

FARMABIOS SPATIROFIBAN HYDROCHLORIDE MONOHYDRATE

DMF 272932013

WISDOM PHARMACEUTICAL CO LTDTIROFIBAN HYDROCHLORIDE

DMF 327012018

WISDOM PHARMACEUTICAL CO LTDInactiveTIROFIBAN HYDROCHLORIDE

DMF 269422013

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

Approval Letters

12 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 14, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INJECTION | Approved: Aug 31, 2016