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
(9 years ago) |
Expired
|
|
US5900423 (Pediatric) | Form of paroxetine hydrochloride anhydrate |
Nov, 2015
(9 years ago) |
Expired
|
|
US6133289 (Pediatric) | Paroxetine hydrochloride form A or C |
Nov, 2015
(9 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
(12 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.
Latest 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 |
|---|---|---|
 | ||
| Expire Patent Critical | 15 Jul, 2019 | US7229640 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 28 Jan, 2019 | US7229640 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 12 Jun, 2007 | US7229640 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 12 Jun, 2007 | US7229640 (Litigated) |
| Issue Notification Mailed Critical | 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 Critical | 23 Feb, 2007 | US7229640 (Litigated) |
| Mail Notice of Allowance Critical | 29 Dec, 2006 | US7229640 (Litigated) |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
| |||
| Sebela Ireland Ltd |
| |||
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 |