Mirvaso is a drug owned by Galderma Laboratories Lp. It is protected by 12 US drug patents filed from 2013 to 2019. Out of these, 11 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 13, 2031. Details of Mirvaso'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). | |||
| US8053427 | Brimonidine gel composition |
Jun, 2031
(6 years from now) | Active |
| US8163725 | Gel compositions and methods of use |
Jun, 2031
(6 years from now) | Active |
| US10201517 | Brimonidine gel compositions and methods of use |
Jun, 2031
(6 years from now) | Active |
| US9861631 | Methods and compositions for safe and effective treatment of erythema |
Mar, 2031
(5 years from now) | Active |
| US8513249 | Methods and compositions for safe and effective treatment of erythema |
Mar, 2031
(5 years from now) | Active |
| US8513247 | Methods and compositions for safe and effective treatment of erythema |
Mar, 2031
(5 years from now) | Active |
| US9861632 | Methods and compositions for safe and effective treatment of erythema |
Mar, 2031
(5 years from now) | Active |
| US7439241 | Compounds, formulations, and methods for treating or preventing rosacea |
Aug, 2025
(3 months from now) | Active |
| US8231885 | Compounds, formulations, and methods for ameliorating telangiectasis |
May, 2025
(11 days from now) | Active |
| US8410102 | Methods and compositions for treating or preventing erythema |
May, 2025
(11 days from now) | Active |
| US8426410 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders |
May, 2025
(11 days from now) | Active |
| US8859551 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders |
May, 2024
(11 months ago) |
Expired
|
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 Mirvaso's patents.
Latest Legal Activities on Mirvaso's Patents
Given below is the list of recent legal activities going on the following patents of Mirvaso.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 Jan, 2024 | US8231885 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Oct, 2023 | US8163725 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 May, 2023 | US8053427 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Aug, 2022 | US10201517 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Apr, 2022 | US8859551 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Jun, 2021 | US9861631 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Jun, 2021 | US9861632 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Feb, 2021 | US8513247 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Feb, 2021 | US8513249 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Sep, 2020 | US8426410 (Litigated) |
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 Mirvaso and ongoing litigations to help you estimate the early arrival of Mirvaso generic.
Mirvaso's Litigations
Mirvaso been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 16, 2014, against patent number US8426410. The petitioner , challenged the validity of this patent, with Jack Dejovin et al as the respondent. Click below to track the latest information on how companies are challenging Mirvaso's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7439241 | May, 2014 |
Decision
(16 May, 2014) | Jack Dejovin et al | |
| US8426410 | May, 2014 |
Decision
(16 May, 2014) | Jack Dejovin et al | |
FDA has granted some exclusivities to Mirvaso. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mirvaso, 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 Mirvaso.
Exclusivity Information
Mirvaso holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Mirvaso's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Aug 23, 2016 |
Several oppositions have been filed on Mirvaso'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 Mirvaso's generic, the next section provides detailed information on ongoing and past EP oppositions related to Mirvaso patents.
Mirvaso's Oppositions Filed in EPO
Mirvaso has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 26, 2012, by Allergan, Inc.. This opposition was filed on patent number EP04753601A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP11185810A | Apr, 2015 | Beiersdorf AG | Patent maintained as amended |
| EP04753601A | Jul, 2012 | ALLERGAN, INC. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Mirvaso 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 Mirvaso's family patents as well as insights into ongoing legal events on those patents.
Mirvaso's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mirvaso's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 13, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mirvaso Generic API suppliers:
Brimonidine Tartrate is the generic name for the brand Mirvaso. 13 different companies have already filed for the generic of Mirvaso, with Sandoz having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mirvaso's generic
How can I launch a generic of Mirvaso before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Mirvaso's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mirvaso'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 Mirvaso -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0033 | 15 Dec, 2014 | 1 | 13 Jun, 2031 | Extinguished |
Alternative Brands for Mirvaso
Mirvaso which is used for treating facial redness associated with rosacea., has several other brand drugs using the same active ingredient (Brimonidine Tartrate). 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 |
| ||
| Alcon Labs Inc |
| ||
| Bausch And Lomb Inc |
| ||
| Sandoz |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Brimonidine Tartrate, Mirvaso's active ingredient. Check the complete list of approved generic manufacturers for Mirvaso
About Mirvaso
Mirvaso is a drug owned by Galderma Laboratories Lp. It is used for treating facial redness associated with rosacea. Mirvaso uses Brimonidine Tartrate as an active ingredient. Mirvaso was launched by Galderma Labs Lp in 2013.
Approval Date:
Mirvaso was approved by FDA for market use on 23 August, 2013.
Active Ingredient:
Mirvaso uses Brimonidine Tartrate as the active ingredient. Check out other Drugs and Companies using Brimonidine Tartrate ingredient
Treatment:
Mirvaso is used for treating facial redness associated with rosacea.
Dosage:
Mirvaso is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.33% BASE | GEL | Prescription | TOPICAL |