Austedo is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is protected by 26 US drug patents filed from 2017 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 15, 2038. Details of Austedo's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US8524733 | Benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Apr, 2031
(6 years from now) | Active |
| US9550780 | Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Sep, 2033
(9 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8524733 (Pediatric) | Benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Oct, 2031
(7 years from now) | Active |
| US9814708 | Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Sep, 2033
(9 years from now) | Active |
| US9296739 | Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Sep, 2033
(9 years from now) | Active |
| US9233959 | Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Sep, 2033
(9 years from now) | Active |
| US11666566 | Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Sep, 2033
(9 years from now) | Active |
|
US9296739 (Pediatric) | Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Mar, 2034
(9 years from now) | Active |
|
US9550780 (Pediatric) | Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Mar, 2034
(9 years from now) | Active |
|
US9814708 (Pediatric) | Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Mar, 2034
(9 years from now) | Active |
|
US11666566 (Pediatric) | Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Mar, 2034
(9 years from now) | Active |
|
US9233959 (Pediatric) | Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2 |
Mar, 2034
(9 years from now) | Active |
| US11564917 | Methods for the treatment of abnormal involuntary movement disorders |
Mar, 2036
(11 years from now) | Active |
| US11357772 | Methods for the treatment of abnormal involuntary movement disorders |
Mar, 2036
(11 years from now) | Active |
| US11648244 | Methods for the treatment of abnormal involuntary movement disorders |
Mar, 2036
(11 years from now) | Active |
| US10959996 | Methods for the treatment of abnormal involuntary movement disorders |
Mar, 2036
(11 years from now) | Active |
| US11446291 | Methods for the treatment of abnormal involuntary movement disorders |
Mar, 2036
(11 years from now) | Active |
|
US11446291 (Pediatric) | Methods for the treatment of abnormal involuntary movement disorders |
Sep, 2036
(12 years from now) | Active |
|
US11648244 (Pediatric) | Methods for the treatment of abnormal involuntary movement disorders |
Sep, 2036
(12 years from now) | Active |
|
US11564917 (Pediatric) | Methods for the treatment of abnormal involuntary movement disorders |
Sep, 2036
(12 years from now) | Active |
|
US11357772 (Pediatric) | Methods for the treatment of abnormal involuntary movement disorders |
Sep, 2036
(12 years from now) | Active |
|
US10959996 (Pediatric) | Methods for the treatment of abnormal involuntary movement disorders |
Sep, 2036
(12 years from now) | Active |
| US11813232 | Analogs of deutetrabenazine, their preparation and use |
Mar, 2038
(13 years from now) | Active |
| US11179386 | Analogs of deutetrabenazine, their preparation and use |
Mar, 2038
(13 years from now) | Active |
|
US11179386 (Pediatric) | Analogs of deutetrabenazine, their preparation and use |
Sep, 2038
(14 years from now) | Active |
|
US11813232 (Pediatric) | Analogs of deutetrabenazine, their preparation and use |
Sep, 2038
(14 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's patents.
Latest Legal Activities on Austedo's Patents
Given below is the list of recent legal activities going on the following patents of Austedo.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jun, 2024 | US9550780 |
| Patent eGrant Notification | 14 Nov, 2023 | US11813232 |
| Recordation of Patent eGrant | 14 Nov, 2023 | US11813232 |
| Patent Issue Date Used in PTA Calculation | 14 Nov, 2023 | US11813232 |
| Mail Patent eGrant Notification | 14 Nov, 2023 | US11813232 |
| Recordation of Patent Grant Mailed | 14 Nov, 2023 | US11813232 |
| Email Notification | 14 Nov, 2023 | US11813232 |
| Email Notification | 27 Oct, 2023 | US11813232 |
| Issue Notification Mailed | 25 Oct, 2023 | US11813232 |
| Application Is Considered Ready for Issue | 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 and ongoing litigations to help you estimate the early arrival of Austedo generic.
Austedo's Litigations
Austedo has 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 or infringement of this patent, with Auspex Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Austedo's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8524733 | September, 2021 | Terminated-Denied | Auspex Pharmaceuticals, Inc. | Apotex Inc. |
FDA has granted some exclusivities to Austedo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Austedo, 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 Austedo.
Exclusivity Information
Austedo holds 6 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Austedo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-751) | Aug 30, 2020 |
| New Chemical Entity Exclusivity(NCE) | Apr 03, 2022 |
| Orphan Drug Exclusivity(ODE) | Apr 03, 2024 |
| Orphan Drug Exclusivity(ODE-134) | Apr 03, 2024 |
| M(M-54) | Jun 24, 2024 |
| Pediatric Exclusivity(PED) | Dec 24, 2024 |
US patents provide insights into the exclusivity only within the United States, but Austedo 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's family patents as well as insights into ongoing legal events on those patents.
Austedo's family patents
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Generic Launch
Generic Release Date:
Austedo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 15, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Austedo Generics:
There are no approved generic versions for Austedo as of now.
How can I launch a generic of Austedo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Austedo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Austedo'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 Austedo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 6 mg, 9 mg and 12 mg | 05 Apr, 2021 | 2 | 07 Mar, 2036 |
About Austedo
Austedo is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is used for treating Huntington's chorea and tardive dyskinesia. Austedo uses Deutetrabenazine as an active ingredient. Austedo was launched by Teva Branded Pharm in 2017.
Market Authorisation Date:
Austedo was approved by FDA for market use on 03 April, 2017.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Austedo is 03 April, 2017, its NCE-1 date is estimated to be 25 December, 2023
Active Ingredient:
Austedo uses Deutetrabenazine as the active ingredient. Check out other Drugs and Companies using Deutetrabenazine ingredient
Treatment:
Austedo is used for treating Huntington's chorea and tardive dyskinesia.
Dosage:
Austedo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 6MG | TABLET | Prescription | ORAL |
| 9MG | TABLET | Prescription | ORAL |
| 12MG | TABLET | Prescription | ORAL |