Alvesco is a drug owned by Covis Pharma Gmbh. It is protected by 9 US drug patents filed in 2013. Out of these, 1 drug patents are active and 8 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 01, 2028. Details of Alvesco'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). | |||
| US6036942 | Seal configuration for aerosol canister |
Apr, 2013
(11 years ago) |
Expired
|
| US5605674 | Medicinal aerosol formulations |
Feb, 2014
(10 years ago) |
Expired
|
| US5683677 | Medicinal aerosol formulations |
Nov, 2014
(9 years ago) |
Expired
|
| US5775321 | Seal configuration for aerosol canister |
Jul, 2015
(9 years ago) |
Expired
|
| US6006745 | Device for delivering an aerosol |
Dec, 2016
(7 years ago) |
Expired
|
| US5482934 | Pregna-1,4-diene3,20-dione-16-17-acetal-21 esters, process for their preparation, composition, and methods for the treatment of inflammatory conditions |
Oct, 2017
(6 years ago) |
Expired
|
| US6120752 | Medicinal aerosol products containing formulations of ciclesonide and related steroids |
May, 2018
(6 years ago) |
Expired
|
| US6264923 | Medicinal aerosol formulation of ciclesonide and related compounds |
May, 2018
(6 years ago) |
Expired
|
| US8371292 | Use of ciclesonide for the treatment of respiratory diseases |
Feb, 2028
(3 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 Alvesco's patents.
Latest Legal Activities on Alvesco's Patents
Given below is the list of recent legal activities going on the following patents of Alvesco.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Jul, 2020 | US8371292 |
| Post Issue Communication - Certificate of Correction | 07 Oct, 2014 | US8371292 |
| Email Notification | 09 Aug, 2014 | US8371292 |
| Mail-Petition Decision - Dismissed | 05 Aug, 2014 | US8371292 |
| Petition Decision - Dismissed | 04 Aug, 2014 | US8371292 |
| Adjustment of PTA Calculation by PTO | 03 Aug, 2014 | US8371292 |
| Petition Entered | 01 Mar, 2013 | US8371292 |
| Patent Issue Date Used in PTA Calculation | 12 Feb, 2013 | US8371292 |
| Recordation of Patent Grant Mailed | 12 Feb, 2013 | US8371292 |
| Issue Notification Mailed | 23 Jan, 2013 | US8371292 |
FDA has granted several exclusivities to Alvesco. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Alvesco, 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 Alvesco.
Exclusivity Information
Alvesco holds 2 exclusivities. All of its exclusivities have expired in 2015. Details of Alvesco's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 20, 2011 |
| M(M-125) | Dec 17, 2015 |
Several oppositions have been filed on Alvesco'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 Alvesco's generic, the next section provides detailed information on ongoing and past EP oppositions related to Alvesco patents.
Alvesco's oppositions filed in EPO
Alvesco has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 25, 2014, by Generics [Uk] Ltd (Trading As Mylan). This opposition was filed on patent number EP04766791A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP04766791A | Sep, 2014 | Generics [UK] Ltd (trading as Mylan) | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Alvesco 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 Alvesco's family patents as well as insights into ongoing legal events on those patents.
Alvesco's family patents
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Generic Launch
Generic Release Date:
Alvesco's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 01, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Alvesco Generics:
There are no approved generic versions for Alvesco as of now.
About Alvesco
Alvesco is a drug owned by Covis Pharma Gmbh. It is used for treating asthma and inflammatory conditions in adolescents and adults. Alvesco uses Ciclesonide as an active ingredient. Alvesco was launched by Covis in 2008.
Market Authorisation Date:
Alvesco was approved by FDA for market use on 10 January, 2008.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Alvesco is 10 January, 2008, its NCE-1 date is estimated to be 20 October, 2010
Active Ingredient:
Alvesco uses Ciclesonide as the active ingredient. Check out other Drugs and Companies using Ciclesonide ingredient
Treatment:
Alvesco is used for treating asthma and inflammatory conditions in adolescents and adults.
Dosage:
Alvesco is available in aerosol, metered form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.16MG/INH | AEROSOL, METERED | Prescription | INHALATION |
| 0.08MG/INH | AEROSOL, METERED | Prescription | INHALATION |