Finacea Patent Expiration

Finacea is a drug owned by Leo Pharma As. It is protected by 10 US drug patents filed from 2013 to 2019. Out of these, 4 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 28, 2029. Details of Finacea'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).
US6534070 Composition with azelaic acid
Nov, 2018

(5 years ago)

Expired
US6730288 Mousse composition
Sep, 2019

(4 years ago)

Expired
US8900554 Foamable composition and uses thereof
Oct, 2023

(8 months ago)

Expired
US8722021 Foamable carriers
Oct, 2023

(8 months ago)

Expired
US10322085 Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Oct, 2023

(8 months ago)

Expired
US8435498 Penetrating pharmaceutical foam
Mar, 2024

(4 months ago)

Expired
US7700076 Penetrating pharmaceutical foam
Sep, 2027

(3 years from now)

Active
US10117812 Foamable composition combining a polar solvent and a hydrophobic carrier
Oct, 2027

(3 years from now)

Active
US9265725 Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Dec, 2027

(3 years from now)

Active
US9211259 Antibiotic kit and composition and uses thereof
Feb, 2029

(4 years from now)

Active

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Several oppositions have been filed on Finacea'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 Finacea's generic, the next section provides detailed information on ongoing and past EP oppositions related to Finacea patents.

Finacea's oppositions filed in EPO

Finacea has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 29, 2014, by Guderma Gmbh. This opposition was filed on patent number EP03772600A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP03772600A Sep, 2015 Henkel AG & Co. KGaA Patent maintained as amended
EP03772600A Dec, 2014 Guderma GmbH Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Finacea 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 Finacea's family patents as well as insights into ongoing legal events on those patents.

Finacea's family patents

Finacea has patent protection in a total of 21 countries. It's US patent count contributes only to 47.6% 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 Finacea.

Family Patents

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Generic Launch

Generic Release Date:

Finacea's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 28, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Finacea Generics:

Azelaic Acid is the generic name for the brand Finacea. 5 different companies have already filed for the generic of Finacea, with Actavis Labs Ut Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Finacea's generic

How can I launch a generic of Finacea before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Finacea's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Finacea'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 Finacea -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0.15 27 Jul, 2012 1 19 Nov, 2018 18 Nov, 2018 Extinguished
0.15 14 Sep, 2017 1 07 Oct, 2020 28 Feb, 2029 Eligible




About Finacea

Finacea is a drug owned by Leo Pharma As. It is used for treating inflammatory papules and pustules of mild to moderate rosacea. Finacea uses Azelaic Acid as an active ingredient. Finacea was launched by Leo Pharma As in 2002.

Market Authorisation Date:

Finacea was approved by FDA for market use on 24 December, 2002.

Active Ingredient:

Finacea uses Azelaic Acid as the active ingredient. Check out other Drugs and Companies using Azelaic Acid ingredient

Treatment:

Finacea is used for treating inflammatory papules and pustules of mild to moderate rosacea.

Dosage:

Finacea is available in aerosol, foam form for topical use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
15% AEROSOL, FOAM Prescription TOPICAL