Dyanavel Xr is a drug owned by Tris Pharma Inc. It is protected by 7 US drug patents filed from 2015 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 07, 2036. Details of Dyanavel Xr'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). | |||
| US11590228 | Extended release amphetamine compositions |
Sep, 2036
(10 years from now) | Active |
| US8062667 | Modified release formulations containing drug-ion exchange resin complexes |
Mar, 2029
(3 years from now) | Active |
| US8597684 | Modified release formulations containing drug-ion exchange resin complexes |
Mar, 2027
(1 year, 4 months from now) | Active |
| US10086087 | Modified release formulations containing drug-ion exchange resin complexes |
Mar, 2027
(1 year, 4 months from now) | Active |
| US8747902 | Modified release formulations containing drug-ion exchange resin complexes |
Mar, 2027
(1 year, 4 months from now) | Active |
| US8883217 | Modified release formulations containing drug-ion exchange resin complexes |
Mar, 2027
(1 year, 4 months from now) | Active |
| US9675703 | Modified release formulations containing drug - ion exchange resin complexes |
Mar, 2027
(1 year, 4 months 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 Dyanavel Xr's patents.
Latest Legal Activities on Dyanavel Xr's Patents
Given below is the list of recent legal activities going on the following patents of Dyanavel Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Post Issue Communication - Certificate of Correction | 06 Nov, 2023 | US11590228 |
| Email Notification
Critical | 29 Sep, 2023 | US11590228 |
| Mail Pub Notice re 312 amendment | 29 Sep, 2023 | US11590228 |
| Post Issue Communication - Certificate of Correction Denied | 27 Sep, 2023 | US11590228 |
| POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION | 26 Sep, 2023 | US11590228 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 May, 2023 | US8062667 (Litigated) |
| Recordation of Patent Grant Mailed
Critical | 28 Feb, 2023 | US11590228 |
| Patent Issue Date Used in PTA Calculation
Critical | 28 Feb, 2023 | US11590228 |
| Application ready for PDX access by participating foreign offices
Critical | 28 Feb, 2023 | US11590228 |
| Email Notification
Critical | 11 Feb, 2023 | US11590228 |
FDA has granted several exclusivities to Dyanavel Xr. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Dyanavel Xr, 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
Dyanavel Xr.
Exclusivity Information
Dyanavel Xr holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Dyanavel Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 19, 2018 |
US patents provide insights into the exclusivity only within the United States, but
Dyanavel Xr 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 Dyanavel Xr's family patents as well as insights into
ongoing legal events
on those patents.
Dyanavel Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Dyanavel Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 07, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Dyanavel Xr Generics:
There are no approved generic versions for Dyanavel Xr as of now.
Alternative Brands for Dyanavel Xr
Dyanavel Xr which is used for managing symptoms of Attention Deficit Hyperactivity Disorder., has several other brand drugs in the same treatment category and using the same active ingredient (Amphetamine; Amphetamine Aspartate/dextroamphetamine Sulfate). 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 | Treatment Area | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Tris Pharma Inc |
| |||||||||
About Dyanavel Xr
Dyanavel Xr is a drug owned by Tris Pharma Inc. It is used for managing symptoms of Attention Deficit Hyperactivity Disorder. Dyanavel Xr uses Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate as an active ingredient. Dyanavel Xr was launched by Tris Pharma Inc in 2015.
Approval Date:
Dyanavel Xr was approved by FDA for market use on 19 October, 2015.
Active Ingredient:
Dyanavel Xr uses Amphetamine; Amphetamine Aspartate/dextroamphetamine Sulfate as the active ingredient. Check out other Drugs and Companies using Amphetamine; Amphetamine Aspartate/dextroamphetamine Sulfate ingredient
Treatment:
Dyanavel Xr is used for managing symptoms of Attention Deficit Hyperactivity Disorder.
Dosage:
Dyanavel Xr is available in suspension, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE | Prescription | ORAL |