Bijuva is a drug owned by Mayne Pharma Llc. It is protected by 24 US drug patents filed from 2018 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 21, 2032. Details of Bijuva'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. | |||
| US11865179 | Progesterone formulations having a desirable PK profile |
Nov, 2032
(8 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). | |||
| US10206932 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US9301920 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US11033626 | Progesterone formulations having a desirable pk profile |
Nov, 2032
(8 years from now) | Active |
| US9006222 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US10806740 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US9114145 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US11793819 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US9114146 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US8933059 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US8846649 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US8846648 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US10675288 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US8993548 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US8987237 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US11166963 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US8993549 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US11529360 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US8633178 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US10639375 | Progesterone formulations |
Nov, 2032
(8 years from now) | Active |
| US10052386 | Progesterone formulations |
Nov, 2032
(8 years from now) | Active |
| US11110099 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US11103516 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(8 years from now) | Active |
| US11103513 | Natural combination hormone replacement formulations and therapies |
Nov, 2032
(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 Bijuva's patents.
Latest Legal Activities on Bijuva's Patents
Given below is the list of recent legal activities going on the following patents of Bijuva.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Mail O.P. Petition Decision | 14 Jun, 2024 | US9301920 |
| Email Notification | 14 Jun, 2024 | US9301920 |
| Petition Decision - Accept Late Payment of Maintenance Fees - Granted | 11 Jun, 2024 | US9301920 |
| Mail-Petition Decision - Accept Late Payment of Maintenance Fees - Granted | 11 Jun, 2024 | US9301920 |
| O.P. Petition Decision | 11 Jun, 2024 | US9301920 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 23 May, 2024 | US9301920 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 May, 2024 | US9301920 |
| Petition to Accept Late Payment of Maintenance Fee Payment Filed | 23 May, 2024 | US9301920 |
| Surcharge, Petition to Accept Pymt After Exp, Unintentional | 23 May, 2024 | US9301920 |
| Expire Patent | 13 May, 2024 | US9301920 |
FDA has granted several exclusivities to Bijuva. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Bijuva, 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 Bijuva.
Exclusivity Information
Bijuva holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Bijuva's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 28, 2021 |
Several oppositions have been filed on Bijuva's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Bijuva's generic, the next section provides detailed information on ongoing and past EP oppositions related to Bijuva patents.
Bijuva's oppositions filed in EPO
Bijuva has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 23, 2019, by Rieck, Markus. This opposition was filed on patent number EP13807121A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP19163006A | Sep, 2022 | Dr. Schön, Neymeyr & Partner Patentanwälte mbB | Granted and Under Opposition |
| EP19163006A | Sep, 2022 | Rieck, Markus | Granted and Under Opposition |
| EP12850845A | Mar, 2022 | Generics [UK] Limited | Granted and Under Opposition |
| EP12850845A | Mar, 2022 | Dr. Schön, Neymeyr & Partner Patentanwälte mbB | Granted and Under Opposition |
| EP12850845A | Mar, 2022 | Rieck, Markus | Granted and Under Opposition |
| EP13807188A | Jan, 2022 | Rieck, Markus | Revoked |
| EP13807121A | Dec, 2019 | Rieck, Markus | Revoked |
US patents provide insights into the exclusivity only within the United States, but Bijuva 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 Bijuva's family patents as well as insights into ongoing legal events on those patents.
Bijuva's family patents
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Generic Launch
Generic Release Date:
Bijuva's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 21, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bijuva Generics:
Estradiol; Progesterone is the generic name for the brand Bijuva. 1 company has already filed for the generic of Bijuva. Check out the entire list of companies who have already received approval for Bijuva's generic
How can I launch a generic of Bijuva before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Bijuva's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Bijuva'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 Bijuva -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/100 mg | 06 Jan, 2020 | 1 | 16 May, 2022 | 21 Nov, 2032 | Eligible |
About Bijuva
Bijuva is a drug owned by Mayne Pharma Llc. It is used for relieving menopause symptoms, including vasomotor symptoms. Bijuva uses Estradiol; Progesterone as an active ingredient. Bijuva was launched by Mayne Pharma in 2021.
Market Authorisation Date:
Bijuva was approved by FDA for market use on 28 December, 2021.
Active Ingredient:
Bijuva uses Estradiol; Progesterone as the active ingredient. Check out other Drugs and Companies using Estradiol; Progesterone ingredient
Treatment:
Bijuva is used for relieving menopause symptoms, including vasomotor symptoms.
Dosage:
Bijuva is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG;100MG | CAPSULE | Prescription | ORAL |
| 0.5MG;100MG | CAPSULE | Prescription | ORAL |