Minivelle is a drug owned by Noven Pharmaceuticals Inc. It is protected by 8 US drug patents filed from 2013 to 2018. Out of these, 4 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 04, 2030. Details of Minivelle's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8231906 | Transdermal estrogen device and delivery |
Jul, 2030
(3 years from now) | Active |
| US9724310 | Transdermal estrogen device and delivery |
Jul, 2028
(1 year, 9 months from now) | Active |
| US5656286 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Aug, 2014
(12 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9833419 | Transdermal estrogen device and delivery |
Jul, 2028
(1 year, 9 months from now) | Active |
| US9730900 | Transdermal estrogen device and delivery |
Jul, 2028
(1 year, 9 months from now) | Active |
| US6841716 | Patch |
Apr, 2020
(6 years ago) |
Expired
|
| US5646286 | Palladium catalyzed vinylic substitution reactions with 2-substituted-pyridines |
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
|
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 Minivelle's patents.
Latest Legal Activities on Minivelle's Patents
Given below is the list of recent legal activities going on the following patents of Minivelle.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 May, 2025 | US9833419 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Jan, 2025 | US9730900 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Jan, 2025 | US9724310 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Jan, 2024 | US8231906 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Jan, 2021 | US9730900 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Jan, 2021 | US9724310 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Jan, 2021 | US9833419 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Dec, 2019 | US8231906 |
| Termination or Final Written Decision | 10 Sep, 2018 | US9833419 |
| Request for Trial Denied
Critical | 12 Jun, 2018 | US9724310 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Minivelle and ongoing
litigations to
help you estimate the early arrival of Minivelle generic.
Minivelle's Litigations
Minivelle been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 04, 2017, against patent number US9730900. The petitioner Mylan Technologies, Inc., challenged the validity of this patent, with Noven Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Minivelle's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9833419 | May, 2018 |
Terminated-Settled
(10 Sep, 2018) | Noven Pharmaceuticals, Inc. | Mylan Technologies, Inc. |
| US9724310 | December, 2017 |
Terminated-Settled
(12 Jun, 2018) | Noven Pharmaceuticals, Inc. | Mylan Technologies, Inc. |
| US9730900 | December, 2017 |
Terminated-Settled
(12 Jun, 2018) | Noven Pharmaceuticals, Inc. | Mylan Technologies, Inc. |
Several oppositions have been filed on Minivelle's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Minivelle's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Minivelle patents.
Minivelle's Oppositions Filed in EPO
Minivelle has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 23, 2016, by 3M Innovative Properties Company. This opposition was filed on patent number EP09790211A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP09790211A | Mar, 2016 | 3M Innovative Properties Company | Revoked |
US patents provide insights into the exclusivity only within the United States, but
Minivelle 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 Minivelle's family patents as well as insights into
ongoing legal events
on those patents.
Minivelle's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Minivelle:
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:
Minivelle's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 04, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Minivelle Generic API suppliers:
Estradiol is the generic name for the brand Minivelle. 26 different companies have already filed for the generic of Minivelle, with Mylan Technologies having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Minivelle's generic
How can I launch a generic of Minivelle before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Minivelle's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Minivelle'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 Minivelle -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 08 May, 2015 | 04 Jul, 2030 | Deferred | 15 Aug, 2018 | Less | |
| 18 Aug, 2014 | 04 Jul, 2030 | Deferred | 15 Aug, 2018 | Less |
Alternative Brands for Minivelle
Minivelle which is used for hormone replacement therapy., 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 Pharms Inc |
| ||||||||
| Novo Nordisk Inc |
| ||||||||
| Organon Usa Organon |
| ||||||||
| Padagis Us |
| ||||||||
| 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, Minivelle's active ingredient. Check the complete list of approved generic manufacturers for Minivelle
About Minivelle
Minivelle is a drug owned by Noven Pharmaceuticals Inc. It is used for hormone replacement therapy. Minivelle uses Estradiol as an active ingredient. Minivelle was launched by Noven in 2014.
Approval Date:
Minivelle was approved by FDA for market use on 23 September, 2014.
Active Ingredient:
Minivelle uses Estradiol as the active ingredient. Check out other Drugs and Companies using Estradiol ingredient
Treatment:
Minivelle is used for hormone replacement therapy.
Dosage:
Minivelle is available in film, extended release form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.0375MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 0.075MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 0.1MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 0.05MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 0.025MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |