Bonjesta is a drug owned by Duchesnay Inc. It is protected by 5 US drug patents filed from 2017 to 2018. 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 Feb 18, 2033. Details of Bonjesta'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). | |||
| US7560122 | Pharmaceutical dosage form bearing pregnancy-friendly indicia |
Jan, 2019
(5 years ago) |
Expired
|
| US9375404 | Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof |
Feb, 2033
(8 years from now) | Active |
| US9526703 | Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof |
Feb, 2033
(8 years from now) | Active |
| US9089489 | Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof |
Feb, 2033
(8 years from now) | Active |
| US9937132 | Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof |
Feb, 2033
(8 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 Bonjesta's patents.
Latest Legal Activities on Bonjesta's Patents
Given below is the list of recent legal activities going on the following patents of Bonjesta.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 15 Jan, 2024 | US9526703 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 26 Jul, 2023 | US9375404 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 12 Dec, 2022 | US9089489 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 29 Sep, 2021 | US9937132 |
| Expire Patent | 16 Aug, 2021 | US7560122 |
| Maintenance Fee Reminder Mailed | 01 Mar, 2021 | US7560122 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 09 Apr, 2020 | US9526703 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 29 Jul, 2019 | US9375404 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 01 Nov, 2018 | US9089489 |
| Patent Issue Date Used in PTA Calculation | 10 Apr, 2018 | US9937132 |
US patents provide insights into the exclusivity only within the United States, but Bonjesta 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 Bonjesta's family patents as well as insights into ongoing legal events on those patents.
Bonjesta's family patents
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Generic Launch
Generic Release Date:
Bonjesta's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 18, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bonjesta Generics:
Doxylamine Succinate; Pyridoxine Hydrochloride is the generic name for the brand Bonjesta. 4 different companies have already filed for the generic of Bonjesta, 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 Bonjesta's generic
How can I launch a generic of Bonjesta before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Bonjesta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Bonjesta'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 Bonjesta -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg/20 mg | 28 Aug, 2018 | 1 | 01 Mar, 2022 | 18 Feb, 2033 | Deferred |
About Bonjesta
Bonjesta is a drug owned by Duchesnay Inc. It is used for managing nausea and vomiting of pregnancy in non-responsive women. Bonjesta uses Doxylamine Succinate; Pyridoxine Hydrochloride as an active ingredient. Bonjesta was launched by Duchesnay in 2016.
Market Authorisation Date:
Bonjesta was approved by FDA for market use on 07 November, 2016.
Active Ingredient:
Bonjesta uses Doxylamine Succinate; Pyridoxine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Doxylamine Succinate; Pyridoxine Hydrochloride ingredient
Treatment:
Bonjesta is used for managing nausea and vomiting of pregnancy in non-responsive women.
Dosage:
Bonjesta is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG;20MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |