Viewing data from:

TIROFIBAN HYDROCHLORIDE

ANDA

TIROFIBAN HYDROCHLORIDE | A206888 | GLAND PHARMA LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: AGGRASTAT(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
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).

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

1 letter from Drugs@FDA

Date	Submission	Document
Dec 1, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

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

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Apr 8, 2021

No patent or exclusivity listings for this strength.