Accupril Patent Expiration

Accupril is a drug owned by Pfizer Pharmaceuticals Ltd. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 04, 2015. Details of Accupril's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5684016

(Pediatric)

Method of treating cardiac insufficiency
May, 2015

(9 years ago)

Expired
US5684016 Method of treating cardiac insufficiency
Nov, 2014

(10 years ago)

Expired

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US patents provide insights into the exclusivity only within the United States, but Accupril 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 Accupril's family patents as well as insights into ongoing legal events on those patents.

Accupril's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Accupril's generic launch date based on the expiry of its last outstanding patent is estimated to be May 04, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Accupril Generic API suppliers:

Quinapril Hydrochloride is the generic name for the brand Accupril. 12 different companies have already filed for the generic of Accupril, with Sun Pharm Inds Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Accupril's generic

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

You can seek FDA approval to launch a generic drug before the expiration of Accupril's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Accupril'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 Accupril -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
5 mg, 10 mg, 20 mg and 40 mg





About Accupril

Accupril is a drug owned by Pfizer Pharmaceuticals Ltd. It is used for treating congestive heart failure. Accupril uses Quinapril Hydrochloride as an active ingredient. Accupril was launched by Pfizer Pharms in 1991.

Approval Date:

Accupril was approved by FDA for market use on 19 November, 1991.

Active Ingredient:

Accupril uses Quinapril Hydrochloride as the active ingredient. Check out other Drugs and Companies using Quinapril Hydrochloride ingredient

Treatment:

Accupril is used for treating congestive heart failure.

Dosage:

Accupril is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL