Imvexxy is a drug owned by Mayne Pharma Llc. It is protected by 20 US drug patents filed from 2018 to 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 02, 2034. Details of Imvexxy'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). | |||
| US11266661 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Feb, 2034
(9 years from now) | Active |
| US10398708 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Dec, 2033
(9 years from now) | Active |
| US10258630 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Dec, 2033
(9 years from now) | Active |
| US9180091 | Soluble estradiol capsule for vaginal insertion |
Dec, 2033
(9 years from now) | Active |
| US10668082 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Jun, 2033
(8 years from now) | Active |
| US10568891 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Jun, 2033
(8 years from now) | Active |
| US10888516 | Soluble estradiol capsule for vaginal insertion |
Jun, 2033
(8 years from now) | Active |
| US11116717 | Soluble estradiol capsule for vaginal insertion |
Jun, 2033
(8 years from now) | Active |
| US11065197 | Soluble estradiol capsule for vaginal insertion |
Jun, 2033
(8 years from now) | Active |
| US11123283 | Soluble estradiol capsule for vaginal insertion |
Jun, 2033
(8 years from now) | Active |
| US10471072 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Jun, 2033
(8 years from now) | Active |
| US11246875 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Nov, 2032
(7 years from now) | Active |
| US9289382 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Nov, 2032
(7 years from now) | Active |
| US11304959 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Nov, 2032
(7 years from now) | Active |
| US10537581 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Nov, 2032
(7 years from now) | Active |
| US10806697 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Nov, 2032
(7 years from now) | Active |
| US11497709 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Nov, 2032
(7 years from now) | Active |
| US11241445 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Nov, 2032
(7 years from now) | Active |
| US10835487 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Nov, 2032
(7 years from now) | Active |
| US11351182 | Vaginal inserted estradiol pharmaceutical compositions and methods |
Nov, 2032
(7 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 Imvexxy's patents.
Latest Legal Activities on Imvexxy's Patents
Given below is the list of recent legal activities going on the following patents of Imvexxy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 17 Jul, 2024 | US11116717 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 17 Jul, 2024 | US10806697 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 17 Jul, 2024 | US10668082 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 17 Jul, 2024 | US10806697 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 17 Jul, 2024 | US10568891 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 17 Jul, 2024 | US10537581 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 17 Jul, 2024 | US10668082 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 17 Jul, 2024 | US10568891 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 17 Jul, 2024 | US10537581 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 17 Jul, 2024 | US11123283 |
FDA has granted several exclusivities to Imvexxy. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Imvexxy, 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 Imvexxy.
Exclusivity Information
Imvexxy holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Imvexxy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 29, 2021 |
Several oppositions have been filed on Imvexxy'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 Imvexxy's generic, the next section provides detailed information on ongoing and past EP oppositions related to Imvexxy patents.
Imvexxy's Oppositions Filed in EPO
Imvexxy 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 Imvexxy 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 Imvexxy's family patents as well as insights into ongoing legal events on those patents.
Imvexxy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Imvexxy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 02, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Imvexxy Generic API suppliers:
Estradiol is the generic name for the brand Imvexxy. 25 different companies have already filed for the generic of Imvexxy, with Mylan Technologies having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Imvexxy's generic
How can I launch a generic of Imvexxy before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Imvexxy's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Imvexxy'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 Imvexxy -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 4 mcg and 10 mcg | 30 Dec, 2019 | 1 | 20 Dec, 2033 |
Alternative Brands for Imvexxy
Imvexxy which is used for treating symptoms of vulvar and vaginal atrophy, as well as moderate to severe dyspareunia., has several other brand drugs using the same active ingredient (Estradiol). 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Abbvie |
| ||||||||
| Agile |
| ||||||||
| Apil |
| ||||||||
| Avion Pharms |
| ||||||||
| Bayer Hlthcare |
| ||||||||
| Exeltis Usa Inc |
| ||||||||
| Janssen Pharms |
| ||||||||
| Mayne Pharma |
| ||||||||
| Millicent |
| ||||||||
| Mylan Speciality Lp |
| ||||||||
| Noven |
| ||||||||
| Noven Pharms Inc |
| ||||||||
| Novo Nordisk Inc |
| ||||||||
| Organon Usa Organon |
| ||||||||
| Padagis Us |
| ||||||||
| Sandoz |
| ||||||||
| Sumitomo Pharma |
| ||||||||
| Teva Branded Pharm |
| ||||||||
| Teva Womens |
| ||||||||
| Wyeth Pharms Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Estradiol, Imvexxy's active ingredient. Check the complete list of approved generic manufacturers for Imvexxy
About Imvexxy
Imvexxy is a drug owned by Mayne Pharma Llc. It is used for treating symptoms of vulvar and vaginal atrophy, as well as moderate to severe dyspareunia. Imvexxy uses Estradiol as an active ingredient. Imvexxy was launched by Mayne Pharma in 2018.
Approval Date:
Imvexxy was approved by FDA for market use on 29 May, 2018.
Active Ingredient:
Imvexxy uses Estradiol as the active ingredient. Check out other Drugs and Companies using Estradiol ingredient
Treatment:
Imvexxy is used for treating symptoms of vulvar and vaginal atrophy, as well as moderate to severe dyspareunia.
Dosage:
Imvexxy is available in insert form for vaginal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.01MG | INSERT | Prescription | VAGINAL |
| 0.004MG | INSERT | Prescription | VAGINAL |