Mirvaso Patent Expiration

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
US8513249 Methods and compositions for safe and effective treatment of erythema
Mar, 2031

(6 years from now)

Active
US8513247 Methods and compositions for safe and effective treatment of erythema
Mar, 2031

(6 years from now)

Active
US9861631 Methods and compositions for safe and effective treatment of erythema
Mar, 2031

(6 years from now)

Active
US9861632 Methods and compositions for safe and effective treatment of erythema
Mar, 2031

(6 years from now)

Active
US7439241 Compounds, formulations, and methods for treating or preventing rosacea
Aug, 2025

(10 months from now)

Active
US8410102 Methods and compositions for treating or preventing erythema
May, 2025

(7 months from now)

Active
US8231885 Compounds, formulations, and methods for ameliorating telangiectasis
May, 2025

(7 months from now)

Active
US8426410 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
May, 2025

(7 months from now)

Active
US8859551 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
May, 2024

(4 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.

Given below is the list of recent legal activities going on the following patents of Mirvaso.

Activity Date Patent Number
Patent litigations
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.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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

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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
Patent litigations
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

Mirvaso has patent protection in a total of 31 countries. It's US patent count contributes only to 27.0% of its total global patent coverage. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Mirvaso.

Family Patents

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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 Generics:

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
Alphagan P
Combigan
Alcon Labs Inc
Simbrinza
Bausch And Lomb Inc
Lumify
Lumify Preservative Free
Sandoz
Qoliana


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