Wellbutrin Xl is a drug owned by Bausch Health Us Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 30, 2018. Details of Wellbutrin Xl'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). | |||
| US6096341 | Delayed release tablet of bupropion hydrochloride |
Oct, 2018
(6 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Wellbutrin Xl 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 Wellbutrin Xl's family patents as well as insights into ongoing legal events on those patents.
Wellbutrin Xl's Family Patents
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Generic Launch
Generic Release Date:
Wellbutrin Xl's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 30, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Wellbutrin Xl Generic API suppliers:
Bupropion Hydrochloride is the generic name for the brand Wellbutrin Xl. 33 different companies have already filed for the generic of Wellbutrin Xl, with Invagen Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Wellbutrin Xl's generic
How can I launch a generic of Wellbutrin Xl before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Wellbutrin Xl's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Wellbutrin Xl'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 Wellbutrin Xl -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg and 300 mg | 21 Sep, 2004 | 1 | 14 Dec, 2006 | 30 Oct, 2018 | Eligible |
Alternative Brands for Wellbutrin Xl
There are several other brand drugs using the same active ingredient (Bupropion Hydrochloride) as Wellbutrin Xl. 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 | ||
|---|---|---|---|
| Axsome |
| ||
| Glaxosmithkline |
| ||
| Nalpropion |
| ||
| Twi Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Bupropion Hydrochloride, Wellbutrin Xl's active ingredient. Check the complete list of approved generic manufacturers for Wellbutrin Xl
About Wellbutrin Xl
Wellbutrin Xl is a drug owned by Bausch Health Us Llc. Wellbutrin Xl uses Bupropion Hydrochloride as an active ingredient. Wellbutrin Xl was launched by Bausch in 2003.
Approval Date:
Wellbutrin Xl was approved by FDA for market use on 28 August, 2003.
Active Ingredient:
Wellbutrin Xl uses Bupropion Hydrochloride as the active ingredient. Check out other Drugs and Companies using Bupropion Hydrochloride ingredient
Dosage:
Wellbutrin Xl is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 300MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |