Paxil Patent Expiration

Paxil is a drug owned by Apotex Inc. It is protected by 18 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 Oct 23, 2019. Details of Paxil'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).
US6063927

(Pediatric)

Paroxetine derivatives
Oct, 2019

(5 years ago)

Expired
US6063927 Paroxetine derivatives
Apr, 2019

(5 years ago)

Expired
US6172233

(Pediatric)

Process for making paroxetine
Jul, 2018

(6 years ago)

Expired
US6172233 Process for making paroxetine
Jan, 2018

(6 years ago)

Expired
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
US5811436

(Pediatric)

Oral liquid compositions containing paroxetine resinate
Mar, 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
US6080759

(Pediatric)

Paroxetine hydrochloride form A
Nov, 2015

(9 years ago)

Expired
US5811436 Oral liquid compositions containing paroxetine resinate
Sep, 2015

(9 years ago)

Expired
US6113944

(Pediatric)

Paroxetine tablets and process to prepare them
Jun, 2015

(9 years ago)

Expired
US5872132 Form of paroxetine hydrochloride anhydrate
May, 2015

(9 years ago)

Expired
US6080759 Paroxetine hydrochloride form A
May, 2015

(9 years ago)

Expired
US5900423 Form of paroxetine hydrochloride anhydrate
May, 2015

(9 years ago)

Expired
US6133289 Paroxetine hydrochloride form A or C
May, 2015

(9 years ago)

Expired
US6113944 Paroxetine tablets and process to prepare them
Dec, 2014

(9 years ago)

Expired


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Paxil and ongoing litigations to help you estimate the early arrival of Paxil generic.

Paxil's Litigations

Paxil been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 25, 2004, against patent number US6063927. The petitioner , challenged the validity of this patent, with FRANCISCUS BERNARDUS GEMM BENNEKER et al as the respondent. Click below to track the latest information on how companies are challenging Paxil's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6063927 May, 2004 Motion Decision
(25 May, 2004)
FRANCISCUS BERNARDUS GEMM BENNEKER et al

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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

Paxil's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Paxil's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 23, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Paxil Generic API suppliers:

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

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

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
10 mg and 20 mg
10 mg/5 mL
10 mg, 20 mg, 30 mg and 40 mg

Alternative Brands for Paxil

Paxil which is used for treating various mental health disorders such as depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, and posttraumatic stress 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 Cr

(uses Paroxetine Hydrochloride)

Used for treating depression, panic disorder, premenstrual disorders, and social anxiety 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's active ingredient. Check the complete list of approved generic manufacturers for Paxil





About Paxil

Paxil is a drug owned by Apotex Inc. It is used for treating various mental health disorders such as depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, and posttraumatic stress disorder. Paxil uses Paroxetine Hydrochloride as an active ingredient. Paxil was launched by Apotex in 1998.

Approval Date:

Paxil was approved by FDA for market use on 09 October, 1998.

Active Ingredient:

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

Treatment:

Paxil is used for treating various mental health disorders such as depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, and posttraumatic stress disorder.

Dosage:

Paxil is available in the following dosage forms - suspension form for oral use, capsule form for oral use, tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
EQ 30MG BASE TABLET Prescription ORAL
EQ 20MG BASE TABLET Prescription ORAL
EQ 10MG BASE TABLET Prescription ORAL
EQ 10MG BASE/5ML SUSPENSION Prescription ORAL
EQ 40MG BASE TABLET Prescription ORAL
EQ 50MG BASE TABLET Discontinued ORAL