Adzenys Er is a drug owned by Neos Therapeutics Inc. It is protected by 3 US drug patents filed in 2017 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 Er'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 |
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 Er's patents.
Latest Legal Activities on Adzenys Er's Patents
Given below is the list of recent legal activities going on the following patents of Adzenys Er.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 21 Oct, 2022 | US9017731 (Litigated) |
| 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 | US9017731 (Litigated) |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 29 Oct, 2018 | US9017731 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 28 Apr, 2015 | US9017731 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 28 Apr, 2015 | US9017731 (Litigated) |
| Issue Notification Mailed Critical | 08 Apr, 2015 | US9017731 (Litigated) |
| Dispatch to FDC | 31 Mar, 2015 | US9017731 (Litigated) |
| Mail Response to 312 Amendment (PTO-271) Critical | 30 Mar, 2015 | US9017731 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Adzenys Er 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 Er's family patents as well as insights into ongoing legal events on those patents.
Adzenys Er's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Adzenys Er'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 Er Generic API suppliers:
Amphetamine is the generic name for the brand Adzenys Er. 1 company has already filed for the generic of Adzenys Er. Check out the entire list of companies who have already received approval for Adzenys Er's generic
Alternative Brands for Adzenys Er
There are several other brand drugs using the same active ingredient (Amphetamine) as Adzenys Er. 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 |
| |||||||
| Noven Pharms Inc |
| |||||||
| Takeda Pharms Usa |
| |||||||
| Teva Womens |
| |||||||
| Tris Pharma Inc |
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Apart from brand drugs containing the same ingredient, some generics have also been filed for Amphetamine, Adzenys Er's active ingredient. Check the complete list of approved generic manufacturers for Adzenys Er
About Adzenys Er
Adzenys Er is a drug owned by Neos Therapeutics Inc. Adzenys Er uses Amphetamine as an active ingredient. Adzenys Er was launched by Neos Theraps Inc in 2017.
Approval Date:
Adzenys Er was approved by FDA for market use on 15 September, 2017.
Active Ingredient:
Adzenys Er uses Amphetamine as the active ingredient. Check out other Drugs and Companies using Amphetamine ingredient
Dosage:
Adzenys Er is available in suspension, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1.25MG BASE/ML | SUSPENSION, EXTENDED RELEASE | Discontinued | ORAL |