Aggrastat Patent Expiration

Aggrastat is a drug owned by Medicure International Inc. It is protected by 6 US drug patents filed from 2013 to 2016 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 01, 2023. Details of Aggrastat's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US5733919 Compositions for inhibiting platelet aggregation
Oct, 2016

(7 years ago)

Expired
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5965581 Compositions for inhibiting platelet aggregation
Oct, 2016

(7 years ago)

Expired
US5972967 Compositions for inhibiting platelet aggregation
Oct, 2016

(7 years ago)

Expired
US5733919 Compositions for inhibiting platelet aggregation
Oct, 2016

(7 years ago)

Expired
US5978698 Angioplasty procedure using nonionic contrast media
Oct, 2017

(6 years ago)

Expired
US6136794 Platelet aggregation inhibition using low molecular weight heparin in combination with a GP IIb/IIIa antagonist
Jan, 2019

(5 years ago)

Expired
US6770660 Method for inhibiting platelet aggregation
May, 2023

(1 year, 2 months ago)

Expired

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US patents provide insights into the exclusivity only within the United States, but Aggrastat is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Aggrastat's family patents as well as insights into ongoing legal events on those patents.

Aggrastat's family patents

Aggrastat has patent protection in a total of 5 countries. It has a significant patent presence in the US with 66.7% of its patents being US patents. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Aggrastat.

Family Patents

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Generic Launch

Generic Release Date:

Aggrastat's generic launch date based on the expiry of its last outstanding patent is estimated to be May 01, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Aggrastat Generics:

Tirofiban Hydrochloride is the generic name for the brand Aggrastat. 3 different companies have already filed for the generic of Aggrastat, with Eugia Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aggrastat's generic

How can I launch a generic of Aggrastat before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Aggrastat's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aggrastat's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Aggrastat -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
12.5 mg/250 mL 03 Oct, 2018 1 08 Apr, 2021 01 May, 2023 Extinguished Non-Forfeiture Deferred
5 mg/100 mL 29 Aug, 2019 1 07 Feb, 2023 01 May, 2023 Extinguished Deferred




About Aggrastat

Aggrastat is a drug owned by Medicure International Inc. It is used for reducing thrombotic coronary events in patients with acute coronary syndrome. Aggrastat uses Tirofiban Hydrochloride as an active ingredient. Aggrastat was launched by Medicure in 1998.

Market Authorisation Date:

Aggrastat was approved by FDA for market use on 14 May, 1998.

Active Ingredient:

Aggrastat uses Tirofiban Hydrochloride as the active ingredient. Check out other Drugs and Companies using Tirofiban Hydrochloride ingredient

Treatment:

Aggrastat is used for reducing thrombotic coronary events in patients with acute coronary syndrome.

Dosage:

Aggrastat is available in the following dosage forms - solution form for intravenous use, injectable form for injection use, solution form for injection use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) INJECTABLE Discontinued INJECTION
EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) SOLUTION Discontinued INTRAVENOUS
EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION Prescription INTRAVENOUS
EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) SOLUTION Prescription INJECTION
EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION Prescription INTRAVENOUS