Dovonex Patent Expiration

Dovonex is a drug owned by Leo Pharma As. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 09, 2015. Details of Dovonex's patents and their expiration are given in the table below.

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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).
USRE39706 Crystalline form of a vitamin D analogue
Jun, 2015

(10 years ago)

Expired
US5763426 Crystalline form of a vitamin D analogue
Jun, 2015

(10 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 Dovonex's patents.

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

Activity Date Patent Number
Patent litigations
Recordation of Patent Grant Mailed 26 Jun, 2007 USRE39706
Electronic Review 09 Jun, 2007 USRE39706
Email Notification 08 Jun, 2007 USRE39706
Issue Notification Mailed 08 Jun, 2007 USRE39706
Receipt into Pubs 09 May, 2007 USRE39706
Dispatch to FDC 08 May, 2007 USRE39706
Dispatch to FDC 03 May, 2007 USRE39706
Application Is Considered Ready for Issue 07 Mar, 2007 USRE39706
Dispatch to FDC 07 Mar, 2007 USRE39706
Issue Fee Payment Received 19 Dec, 2006 USRE39706

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

Dovonex's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Dovonex's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 09, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Dovonex Generic API suppliers:

Calcipotriene is the generic name for the brand Dovonex. 6 different companies have already filed for the generic of Dovonex, with Chartwell Rx having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Dovonex's generic

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

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

Strength Submission Date Expiration Date of Last Qualifying Patent 180-Day Status First Applicant Approval Generic Competition Status
25 mg / 5 mL
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02 Dec, 2009 09 Jun, 2015 Eligible 30 May, 2012 Less
25 mg / 5 mL
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19 May, 2006 09 Jun, 2015 Eligible 06 May, 2008 Less


Alternative Brands for Dovonex

There are several other brand drugs using the same active ingredient (Calcipotriene) as Dovonex. 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
Leo Pharma As
Enstilar
Taclonex
Mayne Pharma
Sorilux
Mc2
Wynzora


Apart from brand drugs containing the same ingredient, some generics have also been filed for Calcipotriene, Dovonex's active ingredient. Check the complete list of approved generic manufacturers for Dovonex





About Dovonex

Dovonex is a drug owned by Leo Pharma As. Dovonex uses Calcipotriene as an active ingredient. Dovonex was launched by Leo in 1996.

Approval Date:

Dovonex was approved by FDA for market use on 22 July, 1996.

Active Ingredient:

Dovonex uses Calcipotriene as the active ingredient. Check out other Drugs and Companies using Calcipotriene ingredient

Dosage:

Dovonex is available in the following dosage forms - cream form for topical use, solution form for topical use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.005% CREAM Prescription TOPICAL
0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION Discontinued TOPICAL