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
(9 months ago) |
Expired
|
| US10322085 | Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof |
Oct, 2023
(9 months ago) |
Expired
|
| US8722021 | Foamable carriers |
Oct, 2023
(9 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 |
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 Finacea's patents.
Latest Legal Activities on Finacea's Patents
Given below is the list of recent legal activities going on the following patents of Finacea.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Dec, 2022 | US10322085 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Apr, 2022 | US10117812 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 Nov, 2021 | US8722021 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Oct, 2021 | US7700076 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Sep, 2020 | US8435498 |
| Patent Issue Date Used in PTA Calculation | 18 Jun, 2019 | US10322085 |
| Recordation of Patent Grant Mailed | 18 Jun, 2019 | US10322085 |
| Email Notification | 30 May, 2019 | US10322085 |
| Post Issue Communication - Certificate of Correction | 29 May, 2019 | US10117812 |
| Issue Notification Mailed | 29 May, 2019 | US10322085 |
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 |
|---|---|---|---|
 | |||
| 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
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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 |