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
(12 years ago) |
Expired
|
| US6024976 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Jan, 2014
(12 years ago) |
Expired
|
| US5958446 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Dec, 2012
(13 years ago) |
Expired
|
| US5474783 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Dec, 2012
(13 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
Clinical Trials
Recent Clinical Trials on Vivelle-dot:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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. 26 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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 27 Apr, 2010 | 12 Aug, 2014 | Extinguished | 19 Dec, 2014 | Less |
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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Abbvie |
| ||||||||
| Agile |
| ||||||||
| Apil |
| ||||||||
| Avion Pharms |
| ||||||||
| Bayer Hlthcare |
| ||||||||
| Exeltis Usa Inc |
| ||||||||
| Janssen Pharms |
| ||||||||
| Mayne Pharma |
| ||||||||
| Millicent Mfg Pr |
| ||||||||
| Noven |
| ||||||||
| Noven Pharms Inc |
| ||||||||
| Novo Nordisk Inc |
| ||||||||
| Organon Usa Organon |
| ||||||||
| Padagis Us |
| ||||||||
| Sumitomo Pharma Am |
| ||||||||
| Teva Branded Pharm |
| ||||||||
| Teva Womens |
| ||||||||
| Viatris |
| ||||||||
| Wyeth Pharms Inc |
|
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 1999.
Approval Date:
Vivelle-dot was approved by FDA for market use on 08 January, 1999.
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 |