Aplenzin is a drug owned by Bausch Health Us Llc. It is protected by 8 US drug patents filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 27, 2026. Details of Aplenzin'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7569610 | Modified release formulations of a bupropion salt |
Jun, 2026
(1 year, 10 months from now) | Active |
| US7241805 | Modified release formulations of a bupropion salt |
Jun, 2026
(1 year, 10 months from now) | Active |
| US7645802 | Bupropion hydrobromide and therapeutic applications |
Jun, 2026
(1 year, 10 months from now) | Active |
| US7572935 | Modified release formulations of a bupropion salt |
Jun, 2026
(1 year, 10 months from now) | Active |
| US7585897 | Modified release formulations of a bupropion salt |
Jun, 2026
(1 year, 10 months from now) | Active |
| US7662407 | Modified release formulations of a bupropion salt |
Jun, 2026
(1 year, 10 months from now) | Active |
| US7671094 | Bupropion hydrobromide and therapeutic applications |
Jun, 2026
(1 year, 10 months from now) | Active |
| US7649019 | Modified release formulations of a bupropion salt |
Jun, 2026
(1 year, 10 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Aplenzin's patents.
Latest Legal Activities on Aplenzin's Patents
Given below is the list of recent legal activities going on the following patents of Aplenzin.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Aug, 2021 | US7671094 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Jul, 2021 | US7662407 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Jun, 2021 | US7645802 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Jun, 2021 | US7649019 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 Feb, 2021 | US7585897 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 Feb, 2021 | US7572935 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 Feb, 2021 | US7569610 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Jan, 2019 | US7241805 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Aug, 2017 | US7671094 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) | 19 May, 2014 | US7662407 |
US patents provide insights into the exclusivity only within the United States, but Aplenzin 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 Aplenzin's family patents as well as insights into ongoing legal events on those patents.
Aplenzin's family patents
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Generic Launch
Generic Release Date:
Aplenzin's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 27, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aplenzin Generics:
There are no approved generic versions for Aplenzin as of now.
How can I launch a generic of Aplenzin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Aplenzin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aplenzin'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 Aplenzin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 174 mg | 28 Sep, 2009 | 1 | 27 Jun, 2026 | Extinguished | |
| 348 mg | 24 Sep, 2009 | 1 | 27 Jun, 2026 | Extinguished | |
| 522 mg | 24 Dec, 2009 | 1 | 27 Jun, 2026 | Extinguished |
About Aplenzin
Aplenzin is a drug owned by Bausch Health Us Llc. It is used for treating major depressive disorder with once-daily dosing. Aplenzin uses Bupropion Hydrobromide as an active ingredient. Aplenzin was launched by Bausch in 2008.
Can you believe Aplenzin received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Market Authorisation Date:
Aplenzin was approved by FDA for market use on 23 April, 2008.
Active Ingredient:
Aplenzin uses Bupropion Hydrobromide as the active ingredient. Check out other Drugs and Companies using Bupropion Hydrobromide ingredient
Treatment:
Aplenzin is used for treating major depressive disorder with once-daily dosing.
Dosage:
Aplenzin is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 174MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 522MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 348MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |