Zyban is a drug owned by Glaxosmithkline. It is protected by 4 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 Aug 12, 2013. Details of Zyban'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). | |||
| US5427798 | Controlled sustained release tablets containing bupropion |
Aug, 2013
(11 years ago) |
Expired
|
| US5731000 | Stabilized pharmaceutical composition containing bupropion |
Aug, 2013
(11 years ago) |
Expired
|
| US5763493 | Stabilized pharmaceutical |
Aug, 2013
(11 years ago) |
Expired
|
| US5358970 | Pharmaceutical composition containing bupropion hydrochloride and a stabilizer |
Aug, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Zyban 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 Zyban's family patents as well as insights into ongoing legal events on those patents.
Zyban's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zyban's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 12, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zyban Generic API suppliers:
Bupropion Hydrochloride is the generic name for the brand Zyban. 33 different companies have already filed for the generic of Zyban, with Invagen Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zyban's generic
How can I launch a generic of Zyban before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zyban's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zyban'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 Zyban -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg |
Alternative Brands for Zyban
There are several other brand drugs using the same active ingredient (Bupropion Hydrochloride) as Zyban. 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 |
| |
| Bausch |
| |
| Glaxosmithkline |
| |
| Nalpropion |
| |
| Twi Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Bupropion Hydrochloride, Zyban's active ingredient. Check the complete list of approved generic manufacturers for Zyban
About Zyban
Zyban is a drug owned by Glaxosmithkline. Zyban uses Bupropion Hydrochloride as an active ingredient. Zyban was launched by Glaxosmithkline in 1997.
Approval Date:
Zyban was approved by FDA for market use on 14 May, 1997.
Active Ingredient:
Zyban uses Bupropion Hydrochloride as the active ingredient. Check out other Drugs and Companies using Bupropion Hydrochloride ingredient
Dosage:
Zyban is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |