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
(12 years ago) |
Expired
|
US5474783 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Dec, 2012
(12 years ago) |
Expired
|
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
Explore Our Curated Drug Screens
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.
Drug Owner | Drug Name | ||||||||
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Abbvie |
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Agile |
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Apil |
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Avion Pharms |
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Bayer Hlthcare |
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Exeltis Usa Inc |
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Janssen Pharms |
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Mayne Pharma |
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Millicent |
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Mylan Speciality Lp |
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Noven |
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Noven Pharms Inc |
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Novo Nordisk Inc |
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Organon Usa Organon |
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Padagis Us |
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Sumitomo Pharma |
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Teva Branded Pharm |
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Teva Womens |
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Wyeth Pharms Inc |
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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 |