Vivlodex is a drug owned by Iceutica Operations Llc. It is protected by 3 US drug patents filed from 2016 to 2018 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 31, 2035. Details of Vivlodex'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). | |||
| US9808468 | Formulation of meloxicam |
Mar, 2035
(9 years from now) | Active |
| US9649318 | Formulation of meloxicam |
Mar, 2035
(9 years from now) | Active |
| US9526734 | Formulation of meloxicam |
Mar, 2033
(7 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 Vivlodex's patents.
Latest Legal Activities on Vivlodex's Patents
Given below is the list of recent legal activities going on the following patents of Vivlodex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 07 May, 2021 | US9808468 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 16 Nov, 2020 | US9649318 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 16 Oct, 2020 | US9649318 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 29 Jun, 2020 | US9526734 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 22 May, 2020 | US9526734 |
| Patent Issue Date Used in PTA Calculation
Critical | 07 Nov, 2017 | US9808468 |
| Recordation of Patent Grant Mailed
Critical | 07 Nov, 2017 | US9808468 |
| Email Notification
Critical | 19 Oct, 2017 | US9808468 |
| Issue Notification Mailed
Critical | 18 Oct, 2017 | US9808468 |
| Application Is Considered Ready for Issue
Critical | 29 Sep, 2017 | US9808468 |
FDA has granted several exclusivities to Vivlodex. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Vivlodex, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Vivlodex.
Exclusivity Information
Vivlodex holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Vivlodex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 22, 2018 |
US patents provide insights into the exclusivity only within the United States, but
Vivlodex 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 Vivlodex's family patents as well as insights into
ongoing legal events
on those patents.
Vivlodex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vivlodex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 31, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vivlodex Generic API suppliers:
Meloxicam is the generic name for the brand Vivlodex. 24 different companies have already filed for the generic of Vivlodex, with Novitium Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vivlodex's generic
How can I launch a generic of Vivlodex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vivlodex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vivlodex'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 Vivlodex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 10 mg | 09 Jan, 2017 | 1 | 01 Jun, 2020 | 31 Mar, 2033 | Extinguished Deferred |
Alternative Brands for Vivlodex
Vivlodex which is used for managing osteoarthritis pain., has several other brand drugs using the same active ingredient (Meloxicam). 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 | |
|---|---|---|
| Avondale Pharms |
| |
| Axsome |
| |
| Azurity |
| |
| Baudax |
| |
| Heron Theraps Inc |
| |
| Nanjing Delova |
| |
| Tersera |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Meloxicam, Vivlodex's active ingredient. Check the complete list of approved generic manufacturers for Vivlodex
About Vivlodex
Vivlodex is a drug owned by Iceutica Operations Llc. It is used for managing osteoarthritis pain. Vivlodex uses Meloxicam as an active ingredient. Vivlodex was launched by Iceutica Operations in 2015.
Approval Date:
Vivlodex was approved by FDA for market use on 22 October, 2015.
Active Ingredient:
Vivlodex uses Meloxicam as the active ingredient. Check out other Drugs and Companies using Meloxicam ingredient
Treatment:
Vivlodex is used for managing osteoarthritis pain.
Dosage:
Vivlodex is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |
| 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |