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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US5656286 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Aug, 2014
(9 years ago) |
Expired
|
| US9724310 | Transdermal estrogen device and delivery |
Jul, 2028
(3 years from now) | Active |
| US8231906 | Transdermal estrogen device and delivery |
Jul, 2030
(5 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6024976 | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
Jan, 2014
(10 years ago) |
Expired
|
| US5646286 | Palladium catalyzed vinylic substitution reactions with 2-substituted-pyridines |
Aug, 2014
(9 years ago) |
Expired
|
| US6841716 | Patch |
Apr, 2020
(4 years ago) |
Expired
|
| US9730900 | Transdermal estrogen device and delivery |
Jul, 2028
(3 years from now) | Active |
| US9833419 | Transdermal estrogen device and delivery |
Jul, 2028
(3 years from now) | Active |
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.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Jan, 2024 | US8231906 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Jan, 2021 | US9833419 |
| 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, 8th Year, Large Entity | 18 Dec, 2019 | US8231906 |
| Termination or Final Written Decision | 10 Sep, 2018 | US9833419 |
| Request for Trial Denied | 12 Jun, 2018 | US9730900 |
| Request for Trial Denied | 12 Jun, 2018 | US9724310 |
| Petition Requesting Trial | 18 May, 2018 | US9833419 |
| Patent Issue Date Used in PTA Calculation | 05 Dec, 2017 | US9833419 |
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 has 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 or infringement 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 | Noven Pharmaceuticals, Inc. | Mylan Technologies, Inc. |
| US9724310 | December, 2017 | Terminated-Settled | Noven Pharmaceuticals, Inc. | Mylan Technologies, Inc. |
| US9730900 | December, 2017 | Terminated-Settled | 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
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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 Generics:
Estradiol is the generic name for the brand Minivelle. 22 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 | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0375 mg/day 0.05 mg/day 0.075 mg/day 0.1 mg/day | 18 Aug, 2014 | 1 | 15 Aug, 2018 | 04 Jul, 2030 | Deferred |
| 0.025 mg/day | 08 May, 2015 | 1 | 15 Aug, 2018 | 04 Jul, 2030 | Deferred |
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.
Market Authorisation 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 |
|---|---|---|---|
| 0.05MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 0.1MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 0.075MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 0.0375MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |
| 0.025MG/24HR | FILM, EXTENDED RELEASE | Prescription | TRANSDERMAL |