Adzenys Xr-odt is a drug owned by Neos Therapeutics. It is protected by 5 US drug patents filed from 2016 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 28, 2032. Details of Adzenys Xr-odt'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). | |||
| US8709491 | Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles |
Jun, 2032
(7 years from now) | Active |
| US9017731 | Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles |
Jun, 2032
(7 years from now) | Active |
| US9265737 | Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles |
Jun, 2032
(7 years from now) | Active |
| US9839619 | Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles |
Jun, 2032
(7 years from now) | Active |
| US8840924 | Compositions and methods of making rapidly dissolving ionically masked formulations |
Apr, 2026
(1 year, 3 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 Adzenys Xr-odt's patents.
Latest Legal Activities on Adzenys Xr-odt's Patents
Given below is the list of recent legal activities going on the following patents of Adzenys Xr-odt.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 21 Oct, 2022 | US9017731 (Litigated) |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 03 Jun, 2021 | US9839619 |
| Email Notification Critical | 09 Apr, 2020 | US9839619 |
| Change in Power of Attorney (May Include Associate POA) Critical | 09 Apr, 2020 | US9839619 |
| Change in Power of Attorney (May Include Associate POA) Critical | 09 Apr, 2020 | US9017731 (Litigated) |
| Email Notification Critical | 09 Apr, 2020 | US9017731 (Litigated) |
| Correspondence Address Change Critical | 08 Apr, 2020 | US9839619 |
| Correspondence Address Change Critical | 08 Apr, 2020 | US9017731 (Litigated) |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 29 Oct, 2018 | US9017731 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 12 Dec, 2017 | US9839619 |
US patents provide insights into the exclusivity only within the United States, but Adzenys Xr-odt 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 Adzenys Xr-odt's family patents as well as insights into ongoing legal events on those patents.
Adzenys Xr-odt's Family Patents
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Generic Launch
Generic Release Date:
Adzenys Xr-odt's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 28, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Adzenys Xr-odt Generic API suppliers:
Amphetamine is the generic name for the brand Adzenys Xr-odt. 1 company has already filed for the generic of Adzenys Xr-odt. Check out the entire list of companies who have already received approval for Adzenys Xr-odt's generic
How can I launch a generic of Adzenys Xr-odt before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Adzenys Xr-odt's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Adzenys Xr-odt'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 Adzenys Xr-odt -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg | 10 May, 2016 | 1 | 22 Jun, 2023 | 28 Jan, 2032 | Deferred |
Alternative Brands for Adzenys Xr-odt
There are several other brand drugs using the same active ingredient (Amphetamine) as Adzenys Xr-odt. 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 | |||||||
|---|---|---|---|---|---|---|---|---|
| Azurity |
| |||||||
| Neos Theraps Inc |
| |||||||
| Noven Pharms Inc |
| |||||||
| Takeda Pharms Usa |
| |||||||
| Teva Womens |
| |||||||
| Tris Pharma Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Amphetamine, Adzenys Xr-odt's active ingredient. Check the complete list of approved generic manufacturers for Adzenys Xr-odt
About Adzenys Xr-odt
Adzenys Xr-Odt is a drug owned by Neos Therapeutics. Adzenys Xr-Odt uses Amphetamine as an active ingredient. Adzenys Xr-Odt was launched by Neos Theraps in 2016.
Approval Date:
Adzenys Xr-odt was approved by FDA for market use on 27 January, 2016.
Active Ingredient:
Adzenys Xr-odt uses Amphetamine as the active ingredient. Check out other Drugs and Companies using Amphetamine ingredient
Dosage:
Adzenys Xr-odt is available in tablet, orally disintegrating, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |
| EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |
| EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |
| EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |
| EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |
| EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE | Prescription | ORAL |