Brisdelle is a drug owned by Sebela Ireland Ltd. It is protected by 5 US drug patents filed from 2013 to 2016. Out of these, 4 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 06, 2029. Details of Brisdelle's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US7598271 | Crystalline paroxetine methane sulfonate |
May, 2025
(9 months from now) | Active |
| US8946251 | Method of treating thermoregulatory dysfunction with paroxetine |
Aug, 2026
(2 years from now) | Active |
| US8658663 | Method of treating thermoregulatory disfunction with paroxetine |
Apr, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5874447 | 4-Phenylpiperidine compounds for treating depression |
Jun, 2017
(7 years ago) |
Expired
|
| US9393237 | Method of treating thermoregulatory dysfunction with paroxetine |
Aug, 2026
(2 years 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 Brisdelle's patents.
Latest Legal Activities on Brisdelle's Patents
Given below is the list of recent legal activities going on the following patents of Brisdelle.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 03 Jan, 2024 | US9393237 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 20 Jul, 2022 | US8946251 (Litigated) |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 11 Aug, 2021 | US8658663 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) | 02 Jul, 2021 | US8658663 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) | 02 Jul, 2021 | US8946251 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) | 02 Jul, 2021 | US9393237 |
| Correspondence Address Change | 30 Jun, 2021 | US8946251 (Litigated) |
| Correspondence Address Change | 30 Jun, 2021 | US9393237 |
| Correspondence Address Change | 30 Jun, 2021 | US8658663 (Litigated) |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 03 Jan, 2020 | US9393237 |
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 Brisdelle and ongoing litigations to help you estimate the early arrival of Brisdelle generic.
Brisdelle's Litigations
Brisdelle has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 30, 2012, against patent number US8658663. The petitioner , challenged the validity or infringement of this patent, with Patricia Allison Tewes Richards as the respondent. Click below to track the latest information on how companies are challenging Brisdelle's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8658663 | January, 2012 | Decision | Patricia Allison Tewes Richards | |
FDA has granted some exclusivities to Brisdelle. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Brisdelle, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Brisdelle.
Exclusivity Information
Brisdelle holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Brisdelle's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 28, 2016 |
US patents provide insights into the exclusivity only within the United States, but Brisdelle 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 Brisdelle's family patents as well as insights into ongoing legal events on those patents.
Brisdelle's family patents
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Generic Launch
Generic Release Date:
Brisdelle's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 06, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Brisdelle Generics:
Paroxetine Mesylate is the generic name for the brand Brisdelle. 2 different companies have already filed for the generic of Brisdelle, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Brisdelle's generic
How can I launch a generic of Brisdelle before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Brisdelle's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Brisdelle'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 Brisdelle -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 7.5 mg | 07 Apr, 2014 | 1 | 13 Mar, 2019 | 06 Apr, 2029 | Extinguished |
About Brisdelle
Brisdelle is a drug owned by Sebela Ireland Ltd. It is used for managing moderate to severe vasomotor symptoms associated with menopause. Brisdelle uses Paroxetine Mesylate as an active ingredient. Brisdelle was launched by Sebela Ireland Ltd in 2013.
Market Authorisation Date:
Brisdelle was approved by FDA for market use on 28 June, 2013.
Active Ingredient:
Brisdelle uses Paroxetine Mesylate as the active ingredient. Check out other Drugs and Companies using Paroxetine Mesylate ingredient
Treatment:
Brisdelle is used for managing moderate to severe vasomotor symptoms associated with menopause.
Dosage:
Brisdelle is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 7.5MG BASE | CAPSULE | Prescription | ORAL |