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AGGRASTAT

NDA

TIROFIBAN HYDROCHLORIDE | N020913 | MEDICURE INTERNATIONAL INC

3 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Medicure International, Inc. v. Nexus Pharmaceuticals, Inc. 1:2019cv07979 1 patentANDA 213947tirofiban hydrochloride	N.D. Ill.	2019-12-05	Terminated 2020-11-30	—
MEDICURE INTERNATIONAL, INC. v. GLAND PHARMA LTD. 2:2018cv16246 2 patentsANDA 206888tirofiban hydrochloride	D.N.J.	2018-11-16	Terminated 2019-08-22	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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

11 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 14, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 17, 2002

#003 — EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Apr 20, 2000