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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6063927 | May, 2004 |
Motion Decision
(25 May, 2004) | FRANCISCUS BERNARDUS GEMM BENNEKER et al | |
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
Explore Our Curated Drug Screens
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.
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 - tablet form for oral use, suspension form for oral use, capsule 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 |