Vivelle-dot Patent Expiration

Vivelle-dot is a drug owned by Sandoz Inc. It is protected by 4 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 Aug 12, 2014. Details of Vivelle-dot'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).
US5656286 Solubility parameter based drug delivery system and method for altering drug saturation concentration
Aug, 2014

(10 years ago)

Expired
US6024976 Solubility parameter based drug delivery system and method for altering drug saturation concentration
Jan, 2014

(10 years ago)

Expired
US5958446 Solubility parameter based drug delivery system and method for altering drug saturation concentration
Dec, 2012

(11 years ago)

Expired
US5474783 Solubility parameter based drug delivery system and method for altering drug saturation concentration
Dec, 2012

(11 years ago)

Expired

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

Vivelle-dot's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Vivelle-dot's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 12, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Vivelle-dot Generic API suppliers:

Estradiol is the generic name for the brand Vivelle-dot. 25 different companies have already filed for the generic of Vivelle-dot, with Mylan Technologies having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vivelle-dot's generic

How can I launch a generic of Vivelle-dot before its drug patent expiration? :

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0.025 mg/day 0.0375 mg/day 0.05 mg/days 0.075 mg/day 0.1 mg/day 27 Apr, 2010 1 19 Dec, 2014 12 Aug, 2014 Extinguished

Alternative Brands for Vivelle-dot

There are several other brand drugs using the same active ingredient (Estradiol) as Vivelle-dot. 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.


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





About Vivelle-dot

Vivelle-Dot is a drug owned by Sandoz Inc. Vivelle-Dot uses Estradiol as an active ingredient. Vivelle-Dot was launched by Sandoz in 2002.

Approval Date:

Vivelle-dot was approved by FDA for market use on 03 May, 2002.

Active Ingredient:

Vivelle-dot uses Estradiol as the active ingredient. Check out other Drugs and Companies using Estradiol ingredient

Dosage:

Vivelle-dot is available in system form for transdermal use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.1MG/24HR SYSTEM Prescription TRANSDERMAL
0.075MG/24HR SYSTEM Prescription TRANSDERMAL
0.05MG/24HR SYSTEM Prescription TRANSDERMAL
0.0375MG/24HR SYSTEM Prescription TRANSDERMAL
0.025MG/24HR SYSTEM Prescription TRANSDERMAL