Evamist is a drug owned by Padagis Us Llc. 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 Nov 30, 2021. Details of Evamist'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). | |||
| US6978945 | Dispensing device |
Nov, 2021
(4 years ago) |
Expired
|
| US6923983 | Transdermal delivery of hormones |
Feb, 2017
(9 years ago) |
Expired
|
| US6299900 | Dermal penetration enhancers and drug delivery systems involving same |
Feb, 2017
(9 years ago) |
Expired
|
| US6818226 | Dermal penetration enhancers and drug delivery systems involving same |
Feb, 2017
(9 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 Evamist's patents.
Latest Legal Activities on Evamist's Patents
Given below is the list of recent legal activities going on the following patents of Evamist.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Notice of Final Determination -Election Required | 09 Jan, 2019 | US6818226 |
| FDA Final Eligibility Letter
Critical | 19 Mar, 2018 | US6818226 |
| Interim Patent Term Extension Granted
Critical | 31 Jan, 2018 | US6818226 |
| Expire Patent
Critical | 28 Aug, 2017 | US6923983 |
| transaction for FDA Determination of Regulatory Review Period | 21 Aug, 2017 | US6818226 |
| transaction for FDA Determination of Regulatory Review Period | 05 Jun, 2017 | US6818226 |
| Interim Patent Term Extension Granted
Critical | 15 Feb, 2017 | US6818226 |
| Second letter to regulating agency to determine regulatory review period | 07 Dec, 2016 | US6818226 |
| Letter from FDA or Dept of Agriculture re PTE application | 26 Apr, 2016 | US6818226 |
| Patent Term Extension Application under 35 USC 156 Filed | 12 Feb, 2013 | US6818226 |
US patents provide insights into the exclusivity only within the United States, but
Evamist 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 Evamist's family patents as well as insights into
ongoing legal events
on those patents.
Evamist's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Evamist:
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:
Evamist's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 30, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Evamist Generic API suppliers:
Estradiol is the generic name for the brand Evamist. 26 different companies have already filed for the generic of Evamist, with Mylan Technologies having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Evamist's generic
Alternative Brands for Evamist
Evamist which is used for managing menopausal and postmenopausal symptoms., has several other brand drugs using the same active ingredient (Estradiol). 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 |
| ||||||||
| Sandoz |
| ||||||||
| 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, Evamist's active ingredient. Check the complete list of approved generic manufacturers for Evamist
About Evamist
Evamist is a drug owned by Padagis Us Llc. It is used for managing menopausal and postmenopausal symptoms. Evamist uses Estradiol as an active ingredient. Evamist was launched by Padagis in 2007.
Approval Date:
Evamist was approved by FDA for market use on 27 July, 2007.
Active Ingredient:
Evamist uses Estradiol as the active ingredient. Check out other Drugs and Companies using Estradiol ingredient
Treatment:
Evamist is used for managing menopausal and postmenopausal symptoms.
Dosage:
Evamist is available in spray form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.53MG/SPRAY | SPRAY | Prescription | TRANSDERMAL |