Paxil Cr Patent Expiration

Paxil Cr is a drug owned by Apotex Inc. It is protected by 13 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 Sep 17, 2017. Details of Paxil Cr'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).
US6121291

(Pediatric)

Paroxetine in the treatment of depression associated with withdrawal from heroin abuse and post-traumatic stress disorder
Sep, 2017

(7 years ago)

Expired
US6121291 Paroxetine in the treatment of depression associated with withdrawal from heroin abuse and post-traumatic stress disorder
Mar, 2017

(7 years ago)

Expired
US6548084

(Pediatric)

Controlled release compositions
Jan, 2017

(7 years ago)

Expired
US7229640

(Pediatric)

Paroxetine controlled release compositions
Jan, 2017

(7 years ago)

Expired
US7229640 Paroxetine controlled release compositions
Jul, 2016

(8 years ago)

Expired
US6548084 Controlled release compositions
Jul, 2016

(8 years ago)

Expired
US5872132

(Pediatric)

Form of paroxetine hydrochloride anhydrate
Nov, 2015

(8 years ago)

Expired
US5900423

(Pediatric)

Form of paroxetine hydrochloride anhydrate
Nov, 2015

(8 years ago)

Expired
US6133289

(Pediatric)

Paroxetine hydrochloride form A or C
Nov, 2015

(8 years ago)

Expired
US6133289 Paroxetine hydrochloride form A or C
May, 2015

(9 years ago)

Expired
US5872132 Form of paroxetine hydrochloride anhydrate
May, 2015

(9 years ago)

Expired
US5900423 Form of paroxetine hydrochloride anhydrate
May, 2015

(9 years ago)

Expired
US5422123

(Pediatric)

Tablets with controlled-rate release of active substances
Dec, 2012

(11 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 Paxil Cr's patents.

Given below is the list of recent legal activities going on the following patents of Paxil Cr.

Activity Date Patent Number
Patent litigations
Expire Patent 15 Jul, 2019 US7229640 (Litigated)
Maintenance Fee Reminder Mailed 28 Jan, 2019 US7229640 (Litigated)
Recordation of Patent Grant Mailed 12 Jun, 2007 US7229640 (Litigated)
Patent Issue Date Used in PTA Calculation 12 Jun, 2007 US7229640 (Litigated)
Issue Notification Mailed 23 May, 2007 US7229640 (Litigated)
Dispatch to FDC 12 Apr, 2007 US7229640 (Litigated)
Receipt into Pubs 12 Apr, 2007 US7229640 (Litigated)
Receipt into Pubs 03 Apr, 2007 US7229640 (Litigated)
Issue Fee Payment Verified 23 Feb, 2007 US7229640 (Litigated)
Mail Notice of Allowance 29 Dec, 2006 US7229640 (Litigated)

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

Paxil Cr's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Paxil Cr's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 17, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Paxil Cr Generics:

Paroxetine Hydrochloride is the generic name for the brand Paxil Cr. 23 different companies have already filed for the generic of Paxil Cr, with Prinston Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Paxil Cr's generic

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

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
25 mg 09 Sep, 2005 1 29 Jun, 2007 17 Sep, 2017 Eligible
37.5 mg 19 May, 2009 1 14 Apr, 2011 17 Mar, 2017 Eligible

Alternative Brands for Paxil Cr

Paxil Cr which is used for treating depression, panic disorder, premenstrual disorders, and social anxiety disorder., has several other brand drugs in the same treatment category and using the same active ingredient (Paroxetine Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Apotex
Paxil

(uses Paroxetine Hydrochloride)

Used for treating various mental health disorders such as depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, and posttraumatic stress disorder.
Sebela Ireland Ltd
Pexeva Used for treating depression and obsessive-compulsive disorder.

Apart from brand drugs containing the same ingredient, some generics have also been filed for Paroxetine Hydrochloride, Paxil Cr's active ingredient. Check the complete list of approved generic manufacturers for Paxil Cr





About Paxil Cr

Paxil Cr is a drug owned by Apotex Inc. It is used for treating depression, panic disorder, premenstrual disorders, and social anxiety disorder. Paxil Cr uses Paroxetine Hydrochloride as an active ingredient. Paxil Cr was launched by Apotex in 1999.

Approval Date:

Paxil Cr was approved by FDA for market use on 16 February, 1999.

Active Ingredient:

Paxil Cr uses Paroxetine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Paroxetine Hydrochloride ingredient

Treatment:

Paxil Cr is used for treating depression, panic disorder, premenstrual disorders, and social anxiety disorder.

Dosage:

Paxil Cr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 12.5MG BASE TABLET, EXTENDED RELEASE Prescription ORAL
EQ 37.5MG BASE TABLET, EXTENDED RELEASE Prescription ORAL
EQ 25MG BASE TABLET, EXTENDED RELEASE Prescription ORAL