Alvesco Patent Expiration

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. Alvesco's patents have been open to challenges since 20 October, 2010. 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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8371292 Use of ciclesonide for the treatment of respiratory diseases
Feb, 2028

(3 years from now)

Active
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
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

(7 years ago)

Expired
US6006745 Device for delivering an aerosol
Dec, 2016

(7 years ago)

Expired
US5775321 Seal configuration for aerosol canister
Jul, 2015

(9 years ago)

Expired
US5683677 Medicinal aerosol formulations
Nov, 2014

(10 years ago)

Expired
US5605674 Medicinal aerosol formulations
Feb, 2014

(10 years ago)

Expired
US6036942 Seal configuration for aerosol canister
Apr, 2013

(11 years 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 Alvesco's patents.

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

Activity Date Patent Number
Patent litigations
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

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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
Patent litigations
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

Alvesco has patent protection in a total of 12 countries. It's US patent count contributes only to 31.6% of its total global patent coverage. Click below to unlock the full patent family tree for Alvesco.

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.

Alternative Brands for Alvesco

Alvesco which is used for treating asthma and inflammatory conditions in adolescents and adults., has several other brand drugs in the same treatment category and using the same active ingredient (Ciclesonide). 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 Treatment Area
Covis
Zetonna

(uses Ciclesonide)

Used for treating inflammatory conditions, seasonal and perennial allergic rhinitis in adults and adolescents, and respiratory diseases in children.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Ciclesonide. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Covis
Omnaris






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.

Approval Date:

Alvesco was approved by FDA for market use on 10 January, 2008.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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