Azstarys is a drug owned by Commave Therapeutics Sa. It is protected by 6 US drug patents filed in 2021 out of which none have expired yet. Azstarys's patents have been open to challenges since 07 May, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 09, 2037. Details of Azstarys'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. | |||
| US10584112 | Methylphenidate-prodrugs, processes of making and using the same |
Dec, 2037
(12 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). | |||
| US10858341 | Compositions comprising methylphenidate-prodrugs, processes of making and using the same |
Dec, 2037
(12 years from now) | Active |
| US10584113 | Methylphenidate-prodrugs, processes of making and using the same |
Dec, 2037
(12 years from now) | Active |
| US10759778 | Methylphenidate-prodrugs, processes of making and using the same |
Dec, 2037
(12 years from now) | Active |
| US10954213 | Compositions comprising methylphenidate-prodrugs, processes of making and using the same |
Dec, 2037
(12 years from now) | Active |
| US9079928 | Methylphenidate-oxoacid conjugates, processes of making and using the same |
Jul, 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 Azstarys's patents.
Latest Legal Activities on Azstarys's Patents
Given below is the list of recent legal activities going on the following patents of Azstarys.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US9079928 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 31 Dec, 2023 | US10858341 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 31 Dec, 2023 | US10759778 |
| transaction for FDA Determination of Regulatory Review Period | 29 Nov, 2023 | US9079928 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Sep, 2023 | US10584112 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Sep, 2023 | US10584113 |
| Email Notification Critical | 17 May, 2023 | US9079928 |
| Electronic Review Critical | 17 May, 2023 | US9079928 |
| Second letter to regulating agency to determine regulatory review period | 16 May, 2023 | US9079928 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Jan, 2023 | US9079928 |
FDA has granted several exclusivities to Azstarys. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Azstarys, 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 Azstarys.
Exclusivity Information
Azstarys holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Azstarys's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 07, 2026 |
US patents provide insights into the exclusivity only within the United States, but Azstarys 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 Azstarys's family patents as well as insights into ongoing legal events on those patents.
Azstarys's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Azstarys's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 09, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Azstarys Generics:
There are no approved generic versions for Azstarys as of now.
About Azstarys
Azstarys is a drug owned by Commave Therapeutics Sa. It is used for managing symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) with Serdexmethylphenidate and Dexmethylphenidate. Azstarys uses Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride as an active ingredient. Azstarys was launched by Commave Therap in 2021.
Approval Date:
Azstarys was approved by FDA for market use on 07 May, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Azstarys is 07 May, 2021, its NCE-1 date is estimated to be 07 May, 2025.
Active Ingredient:
Azstarys uses Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride as the active ingredient. Check out other Drugs and Companies using Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride ingredient
Treatment:
Azstarys is used for managing symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) with Serdexmethylphenidate and Dexmethylphenidate.
Dosage:
Azstarys is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10.4MG BASE;EQ 52.3MG BASE | CAPSULE | Prescription | ORAL |
| EQ 5.2MG BASE;EQ 26.1MG BASE | CAPSULE | Prescription | ORAL |
| EQ 7.8MG BASE;EQ 39.2MG BASE | CAPSULE | Prescription | ORAL |