Venlafaxine Hydrochloride is a drug owned by Osmotica Pharmaceutical Us Llc. 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 Mar 20, 2017. Details of Venlafaxine Hydrochloride'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). | |||
| US6419958 | Extended release formulation of venlafaxine hydrochloride |
Mar, 2017
(7 years ago) |
Expired
|
| US6403120 | Extended release formulation of venlafaxine hydrochloride |
Mar, 2017
(7 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Venlafaxine Hydrochloride 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 Venlafaxine Hydrochloride's family patents as well as insights into ongoing legal events on those patents.
Venlafaxine Hydrochloride's Family Patents
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Generic Launch
Generic Release Date:
Venlafaxine Hydrochloride's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 20, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Venlafaxine Hydrochloride Generic API suppliers:
Venlafaxine Hydrochloride is the generic name for the brand Venlafaxine Hydrochloride. 39 different companies have already filed for the generic of Venlafaxine Hydrochloride, with Cadila Pharms Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Venlafaxine Hydrochloride's generic
How can I launch a generic of Venlafaxine Hydrochloride before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Venlafaxine Hydrochloride's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Venlafaxine Hydrochloride'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 Venlafaxine Hydrochloride -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 37.5 mg, 75 mg and 150 mg | 12 Feb, 2009 | 1 | 18 Aug, 2010 | 20 Mar, 2017 | Eligible |
| 225 mg | 10 Jan, 2011 | 1 | 08 Jan, 2019 | 20 Mar, 2017 | Extinguished |
Alternative Brands for Venlafaxine Hydrochloride
Venlafaxine Hydrochloride which is used for treating major depressive disorder (MDD) and social anxiety disorder., has several other brand drugs in the same treatment category and using the same active ingredient (Venlafaxine 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 | ||||
|---|---|---|---|---|---|---|
| Abbvie |
| |||||
| Astrazeneca |
| |||||
| Otsuka |
| |||||
| Upjohn |
| |||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Venlafaxine Hydrochloride, Venlafaxine Hydrochloride's active ingredient. Check the complete list of approved generic manufacturers for Venlafaxine Hydrochloride
About Venlafaxine Hydrochloride
Venlafaxine Hydrochloride is a drug owned by Osmotica Pharmaceutical Us Llc. It is used for treating major depressive disorder (MDD) and social anxiety disorder. Venlafaxine Hydrochloride uses Venlafaxine Hydrochloride as an active ingredient. Venlafaxine Hydrochloride was launched by Osmotica Pharm Us in 2008.
Approval Date:
Venlafaxine Hydrochloride was approved by FDA for market use on 20 May, 2008.
Active Ingredient:
Venlafaxine Hydrochloride uses Venlafaxine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Venlafaxine Hydrochloride ingredient
Treatment:
Venlafaxine Hydrochloride is used for treating major depressive disorder (MDD) and social anxiety disorder.
Dosage:
Venlafaxine Hydrochloride is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 150MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 225MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 37.5MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 75MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |