Austedo Xr is a drug owned by Teva Neuroscience Inc. It is protected by 21 US drug patents filed from 2023 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 10, 2041. Details of Austedo 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9550780 | Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Sep, 2033
(8 years from now) | Active |
| US8524733 | Benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Apr, 2031
(5 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11311488 | Osmotic dosage forms comprising deutetrabenazine and methods of use thereof |
Jun, 2041
(16 years from now) | Active |
|
US11179386 (Pediatric) | Analogs of deutetrabenazine, their preparation and use |
Sep, 2038
(13 years from now) | Active |
|
US11813232 (Pediatric) | Analogs of deutetrabenazine, their preparation and use |
Sep, 2038
(13 years from now) | Active |
| US11179386 | Analogs of deutetrabenazine, their preparation and use |
Mar, 2038
(12 years from now) | Active |
| US11813232 | Analogs of deutetrabenazine, their preparation and use |
Mar, 2038
(12 years from now) | Active |
|
US12016858 (Pediatric) | Methods for the treatment of abnormal involuntary movement disorders |
Sep, 2036
(11 years from now) | Active |
|
US11648244 (Pediatric) | Methods for the treatment of abnormal involuntary movement disorders |
Sep, 2036
(11 years from now) | Active |
|
US11446291 (Pediatric) | Methods for the treatment of abnormal involuntary movement disorders |
Sep, 2036
(11 years from now) | Active |
|
US11564917 (Pediatric) | Methods for the treatment of abnormal involuntary movement disorders |
Sep, 2036
(11 years from now) | Active |
|
US10959996 (Pediatric) | Methods for the treatment of abnormal involuntary movement disorders |
Sep, 2036
(11 years from now) | Active |
|
US11357772 (Pediatric) | Methods for the treatment of abnormal involuntary movement disorders |
Sep, 2036
(11 years from now) | Active |
| US11357772 | Methods for the treatment of abnormal involuntary movement disorders |
Mar, 2036
(10 years from now) | Active |
| US10959996 | Methods for the treatment of abnormal involuntary movement disorders |
Mar, 2036
(10 years from now) | Active |
| US11446291 | Methods for the treatment of abnormal involuntary movement disorders |
Mar, 2036
(10 years from now) | Active |
| US11564917 | Methods for the treatment of abnormal involuntary movement disorders |
Mar, 2036
(10 years from now) | Active |
| US11648244 | Methods for the treatment of abnormal involuntary movement disorders |
Mar, 2036
(10 years from now) | Active |
| US12016858 | Methods for the treatment of abnormal involuntary movement disorders |
Mar, 2036
(10 years from now) | Active |
|
US9550780 (Pediatric) | Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Mar, 2034
(8 years from now) | Active |
|
US8524733 (Pediatric) | Benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Oct, 2031
(6 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 Austedo Xr's patents.
Latest Legal Activities on Austedo Xr's Patents
Given below is the list of recent legal activities going on the following patents of Austedo Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jun, 2024 | US9550780 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Nov, 2023 | US11813232 |
| Recordation of Patent Grant Mailed Critical | 14 Nov, 2023 | US11813232 |
| Email Notification Critical | 14 Nov, 2023 | US11813232 |
| Recordation of Patent eGrant | 14 Nov, 2023 | US11813232 |
| Patent eGrant Notification | 14 Nov, 2023 | US11813232 |
| Mail Patent eGrant Notification | 14 Nov, 2023 | US11813232 |
| Email Notification Critical | 27 Oct, 2023 | US11813232 |
| Issue Notification Mailed Critical | 25 Oct, 2023 | US11813232 |
| Application Is Considered Ready for Issue Critical | 16 Oct, 2023 | US11813232 |
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 Austedo Xr and ongoing litigations to help you estimate the early arrival of Austedo Xr generic.
Austedo Xr's Litigations
Austedo Xr been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Sep 08, 2021, against patent number US8524733. The petitioner Apotex Inc., challenged the validity of this patent, with Auspex Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Austedo Xr's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8524733 | September, 2021 |
Terminated-Denied
(09 Mar, 2022) | Auspex Pharmaceuticals, Inc. | Apotex Inc. |
US patents provide insights into the exclusivity only within the United States, but Austedo 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 Austedo Xr's family patents as well as insights into ongoing legal events on those patents.
Austedo Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Austedo Xr's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 10, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Austedo Xr Generic API suppliers:
Deutetrabenazine is the generic name for the brand Austedo Xr. 1 company has already filed for the generic of Austedo Xr. Check out the entire list of companies who have already received approval for Austedo Xr's generic
Alternative Brands for Austedo Xr
Austedo Xr which is used for managing movement disorders associated with neurological conditions., has several other brand drugs in the same treatment category and using the same active ingredient (Deutetrabenazine). 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Deutetrabenazine, Austedo Xr's active ingredient. Check the complete list of approved generic manufacturers for Austedo Xr
About Austedo Xr
Austedo Xr is a drug owned by Teva Neuroscience Inc. It is used for managing movement disorders associated with neurological conditions. Austedo Xr uses Deutetrabenazine as an active ingredient. Austedo Xr was launched by Teva in 2023.
Approval Date:
Austedo Xr was approved by FDA for market use on 17 February, 2023.
Active Ingredient:
Austedo Xr uses Deutetrabenazine as the active ingredient. Check out other Drugs and Companies using Deutetrabenazine ingredient
Treatment:
Austedo Xr is used for managing movement disorders associated with neurological conditions.
Dosage:
Austedo Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 42MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 30MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 18MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 24MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 48MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 6MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 36MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 12MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |