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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US5733919 | Compositions for inhibiting platelet aggregation |
Oct, 2016
(8 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6770660 | Method for inhibiting platelet aggregation |
May, 2023
(2 years ago) |
Expired
|
| US6136794 | Platelet aggregation inhibition using low molecular weight heparin in combination with a GP IIb/IIIa antagonist |
Jan, 2019
(6 years ago) |
Expired
|
| US5978698 | Angioplasty procedure using nonionic contrast media |
Oct, 2017
(7 years ago) |
Expired
|
| US5733919 | Compositions for inhibiting platelet aggregation |
Oct, 2016
(8 years ago) |
Expired
|
| US5972967 | Compositions for inhibiting platelet aggregation |
Oct, 2016
(8 years ago) |
Expired
|
| US5965581 | Compositions for inhibiting platelet aggregation |
Oct, 2016
(8 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Aggrastat's patents.
Latest Legal Activities on Aggrastat's Patents
Given below is the list of recent legal activities going on the following patents of Aggrastat.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 03 Aug, 2004 | US6770660 |
| Recordation of Patent Grant Mailed Critical | 03 Aug, 2004 | US6770660 |
| Issue Notification Mailed Critical | 15 Jul, 2004 | US6770660 |
| Receipt into Pubs | 08 Jul, 2004 | US6770660 |
| Application Is Considered Ready for Issue Critical | 06 Jul, 2004 | US6770660 |
| Dispatch to FDC | 06 Jul, 2004 | US6770660 |
| Issue Fee Payment Received Critical | 15 Jun, 2004 | US6770660 |
| Issue Fee Payment Verified Critical | 15 Jun, 2004 | US6770660 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 15 Jun, 2004 | US6770660 |
| Change in Power of Attorney (May Include Associate POA) Critical | 14 Jun, 2004 | US6770660 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 2002.
Approval Date:
Aggrastat was approved by FDA for market use on 17 May, 2002.
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 25MG BASE/500ML (EQ 0.05MG BASE/ML) | SOLUTION | Discontinued | INTRAVENOUS |
| EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |
| EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) | INJECTABLE | Discontinued | INJECTION |
| EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | SOLUTION | Prescription | INJECTION |
| EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | SOLUTION | Prescription | INTRAVENOUS |